Drugs / Cabozantinib
Cabozantinib
also known as
XL184 · Cabozantinib S-malate · cabometyx · BMS-907351 · BMS-907351 FREE BASE · Cabo · CABOZANTINIB (BMS-907351) · Cabozantinib malate · +5 more
Small molecule targets AXL, FLT3, KDR, KIT, MET, RET, ROS1, TYRO3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 22 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed differentiated thyroid carcinoma 1 milestone | |||||
| Filed | US (FDA) | CABOMETYX | differentiated thyroid carcinoma | 2021-08-05 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for CABOMETYX® (cabozantinib)” exelixis.com ↗ |
| Filed hepatocellular carcinoma 3 milestones | |||||
| Filed | Japan (PMDA) | CABOMETYX | hepatocellular carcinoma | 2020-01-29 | “Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX® (cabozantinib) in Japan, has applied to...” exelixis.com ↗ |
| Filed | EU (EMA) | Cabometyx | hepatocellular carcinoma | 2018-03-28 | “the European Medicines Agency validated its application for a new indication for cabozantinib as a treatment for previously treated advanced HCC” exelixis.com ↗ “On March 28, 2018, Ipsen announced that the European Medicines Agency validated its application” exelixis.com ↗ |
| Filed | US (FDA) | CABOMETYX | hepatocellular carcinoma | 2018-03-15 | “the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for CABOMETYX® (cabozantinib) tablets as a treatment for patients...” ipsen.com ↗ “On March 15, 2018, Exelixis announced the completed submission of a supplemental New Drug Application (sNDA) to the FDA for CABOMETYX” exelixis.com ↗ “FDA accepted for filing the company’s sNDA for CABOMETYX tablets as a treatment for patients with previously treated advanced HCC.” exelixis.com ↗ |
| Filed medullary thyroid gland carcinoma 2 milestones | |||||
| Filed | EU (EMA) | COMETRIQ | medullary thyroid gland carcinoma | 2012-11-29 | “Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for COMETRIQ™ (cabozantinib)” exelixis.com ↗ |
| Filed | US (FDA) | — | medullary thyroid gland carcinoma | 2012-05-30 | “Exelixis recently submitted a New Drug Application (NDA) for cabozantinib in MTC to the U.S. Food and Drug Administration” exelixis.com ↗ “completed the rolling submission of its New Drug Application (NDA) for cabozantinib” exelixis.com ↗ “completed its NDA submission in May 2012” exelixis.com ↗ |
| Filed pancreatic neuroendocrine tumor 1 milestone | |||||
| Filed | US (FDA) | CABOMETYX | pancreatic neuroendocrine tumor | 2024-08-06 | “FDA accepted its sNDA for cabozantinib for patients with previously treated advanced pancreatic NET (pNET), and for patients with previously treated advanced extra-pancreatic...” exelixis.com ↗ “the U.S. Food and Drug Administration (FDA) had accepted the supplemental New Drug Application (sNDA) for cabozantinib” exelixis.com ↗ “following the FDA’s acceptance of its sNDA and assignment of a PDUFA target action date of April 3, 2025” exelixis.com ↗ “its supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) has been accepted in the U.S.” exelixis.com ↗ |
| Filed renal cell adenocarcinoma 5 milestones | |||||
| Filed | EU (EMA) | CABOMETYX | renal cell adenocarcinoma | 2020-09-19 | “Ipsen and Bristol Myers Squibb have each submitted type II variation applications for Cabometyx® in combination with Opdivo® to the European Medicines Agency (EMA).” ipsen.com ↗ “each submitted type II variation applications for Opdivo plus CABOMETYX to the European Medicines Agency (EMA).” exelixis.com ↗ “each submitted type II variation applications for Opdivo plus CABOMETYX to the European Medicines Agency (EMA).” bms.com ↗ |
| Filed | Japan (PMDA) | CABOMETYX | renal cell adenocarcinoma | 2019-04-25 | “submitted a supplemental application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Manufacturing and Marketing Approval of CABOMETYX in combination with OPDIVO” exelixis.com ↗ “In April 2019, Takeda applied for approval to manufacture and sell cabozantinib as a treatment for unresectable and metastatic renal cell carcinoma (RCC) in Japan.” exelixis.com ↗ “has applied to the Japanese Ministry of Health, Labor and Welfare (MHLW) for approval to manufacture and sell CABOMETYX®” exelixis.com ↗ |
| Filed | EU (EMA) | CABOMETYX | renal cell adenocarcinoma | 2017-08-28 | “to European Medicines Agency (EMA) the regulatory dossier for cabozantinib as a treatment for first-line advanced RCC in the European Union on August 28, 2017;” exelixis.com ↗ “submitted type II variation applications for CABOMETYX in combination with OPDIVO for the treatment of metastatic RCC to the European Medicines Agency (EMA)” exelixis.com ↗ “Cabometyx® (cabozantinib) in combination with nivolumab for 1L renal cell carcinoma (RCC) filing with EMA based on successful Phase 3 CheckMate -9ER” ipsen.com ↗ “The validations of the type II variation applications to the European Medicines Agency (EMA) for Cabometyx® in combination with Opdivo® last year” ipsen.com ↗ “submitted to the EMA the regulatory dossier for cabozantinib as a treatment for first-line advanced RCC in the European Union on August 28, 2017” exelixis.com ↗ “the European Medicines Agency (EMA) had validated BMS' and Ipsen’s type II variation applications for cabozantinib plus nivolumab” exelixis.com ↗ |
| Filed | EU (EMA) | — | renal cell adenocarcinoma | 2016-01-11 | “today announced that it has submitted a Marketing Authorization Application (MAA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC)” exelixis.com ↗ “On January 11, 2016, Exelixis announced the submission of a Marketing Authorization Application (MAA) for cabozantinib as a treatment for patients with advanced RCC” exelixis.com ↗ |
| Filed | US (FDA) | CABOMETYX | renal cell adenocarcinoma | 2015-10-22 | “Bristol Myers Squibb and Exelixis recently completed their respective U.S. Food and Drug Administration (FDA) submissions for Opdivo in combination with CABOMETYX” exelixis.com ↗ “In August 2020, Exelixis announced the submission of an sNDA to the FDA for CABOMETYX in combination with Bristol Myers Squibb’s (BMS) OPDIVO” exelixis.com ↗ “completed the submission of its rolling New Drug Application (NDA) for cabozantinib as a treatment for patients with advanced RCC” exelixis.com ↗ “the company has filed the first component of the application for potential approval of cabozantinib in the United States.” exelixis.com ↗ “recently completed their respective U.S. FDA submissions for Cabometyx® in combination with Opdivo®” ipsen.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (7) | US (FDA) | CABOMETYX | — | 2017-12-19 – 2025-09-10 | fda.gov ↗ |
| Label expansion | US (FDA) | COMETRIQ | — | 2016-05-20 | fda.gov ↗ |
| Approved | EU (EMA) | Cometriq | — | 2014-03-21 | europa.eu ↗ |
| Approved | US (FDA) | COMETRIQ | — | 2012-11-29 | fda.gov ↗ |
Trials 239 · started per year
today
US approved 2012
EU approved 2014
1
3
2
3
4
16
17
8
7
4
10
25
19
38
22
23
18
7
6
6
20062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05188118 | Feb 2023 → Feb 2025 | renal cell carcinoma | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 143 trials · 1 missed | ||||||
| Phase 1 | NCT07848295 | Dec 2026 → Oct 2030 expected | clear cell renal carcinoma | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06502171 | Jun 2026 → Aug 2033 expected | neurofibromatosis type 1, plexiform neurofibroma | Girish Dhall, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT07187869 | Mar 2026 → Apr 2027 expected | clear cell renal carcinoma | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07194044 | Feb 2026 → Oct 2030 expected | Ewing sarcoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT06132945 | Nov 2023 → Nov 2027 expected | metastatic malignant neoplasm in the brain, renal cell carcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06156410 | Oct 2023 → Nov 2027 expected | Ewing sarcoma, osteosarcoma | Children's Hospital of Philadelphia | Recruiting | No outcome recorded |
| Phase 1 | NCT06026410 | Oct 2023 → Jan 2027 expected | clear cell renal carcinoma, colorectal cancer, non-small cell lung carcinoma, pancreatic ductal adenocarcinoma | Kura Oncology, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05613894 | Jul 2023 → Dec 2026 | prostate carcinoma | University of Utah | Suspended | No outcome recorded |
| Phase 1 | NCT05249114 | Dec 2022 → Dec 2027 expected | neuroendocrine neoplasm | Providence Health & Services | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05536141 | Oct 2022 → Mar 2029 expected | clear cell renal carcinoma | Arcus Biosciences, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05092373 | Apr 2022 → Sep 2026 overdue | endometrial carcinoma, fallopian tube carcinoma, female breast carcinoma, hepatocellular carcinoma +5 | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05038839 | Feb 2022 → May 2026 | refractory malignant neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT04514484 | Nov 2021 → Nov 2024 overdue | HIV infectious disease, Kaposi's sarcoma, castration-resistant prostate carcinoma, cutaneous melanoma +14 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04878029 | Jul 2021 → Nov 2027 expected | infiltrating bladder urothelial carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 1 | NCT04868773 | Jul 2021 → Aug 2023 | colorectal carcinoma, metastatic malignant neoplasm | University of California, Irvine | Completed | No outcome recorded |
| Phase 1 | NCT04477512 | Feb → Sep 2021 | metastatic prostate carcinoma | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT04661852 | Dec 2020 → Oct 2022 | Ewing sarcoma, osteosarcoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT04540705 | Sep 2020 → Jan 2024 | renal cell carcinoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04173338 | Jan 2020 → Mar 2022 | malignant mesothelioma, non-small cell lung carcinoma, urothelial carcinoma | Augusta University | Terminated | No outcome recorded |
| Phase 1 | NCT03816345 | Jul 2019 → Mar 2028 expected | Crohn disease, Sjogren syndrome, cancer, dermatomyositis +7 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT03667482 | Sep 2018 → Jul 2024 | head and neck squamous cell carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03611595 | Aug 2018 → Feb 2026 | cancer | Peter Zage | Completed | No outcome recorded |
| Phase 1 | NCT03200587 | Jun 2018 → Apr 2020 | renal cell carcinoma | University of Utah | Completed | No outcome recorded |
| Phase 1 | NCT03299946 | May 2018 → Dec 2019 | hepatocellular carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 1 | NCT03170960 | Sep 2017 → Feb 2023 overdue | castration-resistant prostate carcinoma, colorectal cancer, differentiated thyroid carcinoma, endometrial cancer +10 | Exelixis | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02496208 | Jul 2015 → Sep 2026 overdue | bladder squamous cell carcinoma, clear cell renal carcinoma, infiltrating bladder urothelial carcinoma sarcomatoid variant, kidney medullary carcinoma +7 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02008383 | Jan 2014 → May 2018 | colorectal cancer | John Strickler, M.D. | Completed | No outcome recorded |
| Phase 1 | NCT01961765 | Nov 2013 → May 2016 | acute myeloid leukemia | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01822522 | Jun 2013 → May 2019 | HIV infectious disease, metastatic malignant neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01835184 | May 2013 → Sep 2014 | melanoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT01761773 | Dec 2012 → Apr 2013 | impaired renal function disease | Exelixis | Completed | No outcome recorded |
| Phase 1 | NCT01709435 | Nov 2012 → Dec 2018 | central nervous system neoplasm, medullary thyroid gland carcinoma, melanoma, refractory malignant neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01663272 | Jul 2012 → Jan 2015 | malignant pancreatic neoplasm | University of Michigan Rogel Cancer Center | Completed | Missed primary |
| Phase 1 | NCT01582295 | Jun 2012 → Aug 2014 | plasma cell myeloma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01574937 | Apr 2012 → Dec 2014 | prostate cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01493869 | Sep 2011 → May 2014 | — | Exelixis | Completed | No outcome recorded |
| Phase 1 | NCT01347788 | Apr 2011 → May 2013 | prostate adenocarcinoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01553656 | Feb 2011 → May 2015 | non-small cell lung carcinoma | Exelixis | Completed | No outcome recorded |
| Phase 1 | NCT01100619 | Apr 2010 → Aug 2012 | renal cell carcinoma, thyroid Hurthle cell carcinoma, thyroid gland papillary carcinoma | Exelixis | Completed | No outcome recorded |
| Phase 1 | NCT01018745 | Jan → Jul 2010 | neoplasm | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00960492 | Sep 2009 → Nov 2012 | giant cell glioblastoma, gliosarcoma | Exelixis | Completed | No outcome recorded |
| Phase 1 | NCT00215605 | Sep 2005 → Apr 2011 | lymphoma, thyroid gland carcinoma | Exelixis | Completed | No outcome recorded |
| Phase 1/222 trials · 1 met primary | ||||||
| Phase 1/2 | NCT07293351 | Mar 2026 → Nov 2029 expected | renal cell carcinoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06811116 | Nov 2025 → Aug 2027 expected | hepatocellular carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06835972 | Feb 2025 → Feb 2027 expected | renal cell carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06716853 | Oct 2024 → Jan 2026 | clear cell renal carcinoma | Genenta Science | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT05797805 | Sep 2023 → May 2026 overdue | hepatocellular carcinoma | Iterion Therapeutics | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05559879 | Aug 2023 → Apr 2027 expected | carcinoma, endometrial cancer | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05663710 | Jun 2023 → Oct 2027 | clear cell renal carcinoma | M.D. Anderson Cancer Center | Suspended | No outcome recorded |
| Phase 1/2 | NCT05039281 | Sep 2022 → Dec 2027 expected | gliosarcoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05048901 | Sep 2021 → Aug 2027 expected | digestive system neuroendocrine neoplasm | National Health Research Institutes, Taiwan | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04497038 | Aug 2021 → May 2023 | adult hepatocellular carcinoma | University of Michigan Rogel Cancer Center | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04151563 | Apr 2021 → Dec 2023 | non-small cell lung carcinoma | Bristol-Myers Squibb | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04300140 | Feb 2021 → Aug 2023 | clear cell renal carcinoma | Aravive, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04220229 | Jun 2020 → Apr 2024 | soft tissue sarcoma | University of Washington | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03425201 | Oct 2019 → Jul 2024 | urothelial carcinoma | CRIS Cancer Foundation | Completed | No outcome recorded |
| Phase 1/2 | NCT03957551 | Aug 2019 → Jun 2024 | metastatic melanoma | John Rieth | Terminated | No outcome recorded |
| Phase 1/2 | NCT03539822 | Oct 2018 → Jun 2028 expected | colorectal cancer, esophageal adenocarcinoma, gastric cancer, hepatocellular carcinoma | Anwaar Saeed | Recruiting | Met primary |
| Phase 1/2 | NCT03201250 | Feb 2018 → Apr 2021 | plasma cell myeloma | University of Nebraska | Terminated | No outcome recorded |
| Phase 1/2 | NCT03149822 | Sep 2017 → Dec 2022 | renal cell carcinoma | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 1/2 | NCT01866293 | May 2013 → Aug 2016 | refractory plasma cell neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01658878 | Oct 2012 → Nov 2024 | hepatocellular carcinoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT01683994 | Sep 2012 → Jul 2018 | prostate neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/2 | NCT00596648 | Feb 2008 → Aug 2012 | non-small cell lung carcinoma | Exelixis | Completed | No outcome recorded |
| Phase 2147 trials · 12 met primary · 6 missed | ||||||
| Phase 2 | NCT06900595 | Feb 2026 → Jun 2029 expected | adrenal cortex carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07151326 | Sep 2025 → Jun 2028 expected | hepatocellular carcinoma | National Health Research Institutes, Taiwan | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06006013 | Jan 2025 → Dec 2027 expected | adrenal cortex carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT05859217 | Dec 2024 → Jun 2026 overdue | non-small cell lung carcinoma | Jun Zhang, MD, PhD | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06341712 | Nov 2024 → Feb 2026 | pediatric osteosarcoma | Ipsen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06535737 | Aug 2024 → Jul 2026 overdue | hepatocellular carcinoma | Chulalongkorn University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05904080 | Feb 2024 → Jun 2028 | nasopharyngeal carcinoma | National Cancer Institute (NCI) | Suspended | No outcome recorded |
| Phase 2 | NCT05931393 | Dec 2023 → Sep 2026 overdue | renal cell carcinoma | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05836571 | Oct 2023 → May 2028 expected | extraskeletal myxoid chondrosarcoma, leiomyosarcoma, liposarcoma, undifferentiated pleomorphic sarcoma | National Cancer Institute LAO | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05127824 | Jul 2023 → Dec 2027 expected | clear cell renal carcinoma | Jodi Maranchie | Recruiting | No outcome recorded |
| Show all 147 trials opens the full record — a long page | ||||||
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05691478 | Mar 2023 → Mar 2030 | conventional osteosarcoma, localized osteosarcoma | National Cancer Institute (NCI) | Suspended | No outcome recorded |
| Phase 318 trials · 6 met primary · 4 missed | ||||||
| Phase 3 | NCT06475989 | Dec 2024 → Sep 2030 expected | differentiated thyroid carcinoma | ECOG-ACRIN Cancer Research Group | Recruiting | No outcome recorded |
| Phase 3 | NCT06364631 | Apr 2024 → May 2032 expected | clear cell renal carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT05092958 | Jun 2022 → Jul 2029 expected | renal pelvis urothelial carcinoma, ureter cancer, urethra transitional cell carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04446117 | Oct 2020 → Apr 2024 overdue | metastatic prostate carcinoma, prostate adenocarcinoma | Exelixis | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04471428 | Oct 2020 → Sep 2022 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT04338269 | Jul 2020 → Jan 2023 | renal cell carcinoma | Hoffmann-La Roche | Terminated | Missed primary |
| Phase 3 | NCT03937219 | Jun 2019 → Jan 2022 overdue | renal cell carcinoma | Exelixis | Active not recruiting | Met primary |
| Phase 3 | NCT03793166 | Jun 2019 → Jan 2028 expected | clear cell renal carcinoma, metastatic carcinoma in the bone, metastatic malignant neoplasm in the lymph nodes, rhabdoid tumor of the kidney +1 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03768063 | Feb 2019 → Jul 2028 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03375320 | Oct 2018 → Aug 2023 overdue | enterochromaffin cell serotonin-producing pancreatic neuroendocrine tumor, functional pancreatic neuroendocrine tumor, lung neuroendocrine neoplasm, non-functional pancreatic neuroendocrine tumor +1 | National Cancer Institute (NCI) | Active not recruiting | Met primary |
| Phase 3 | NCT03690388 | Oct 2018 → Aug 2020 overdue | differentiated thyroid carcinoma | Exelixis | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03755791 | Jun 2018 → Nov 2021 overdue | hepatocellular carcinoma | Exelixis | Active not recruiting | Mixed |
| Phase 3 | NCT03141177 | Jul 2017 → Feb 2020 overdue | renal cell carcinoma | Bristol-Myers Squibb | Active not recruiting | Met primary |
| Phase 3 | NCT01908426 | Sep 2013 → Oct 2017 | hepatocellular carcinoma | Exelixis | Completed | Met primary |
| Phase 3 | NCT01865747 | Jun 2013 → May 2015 | renal cell carcinoma | Exelixis | Completed | Met primary |
| Phase 3 | NCT01605227 | Jul 2012 → Sep 2014 | castration-resistant prostate carcinoma | Exelixis | Completed | Missed primary |
| Phase 3 | NCT01522443 | Mar 2012 → Oct 2014 | castration-resistant prostate carcinoma | Exelixis | Terminated | Missed primary |
| Phase 3 | NCT00704730 | Jun 2008 → Oct 2011 | thyroid cancer | Exelixis | Completed | Met primary |
| Phase 44 trials · 1 missed | ||||||
| Phase 4 | NCT07010393 | Jul 2025 → Dec 2027 expected | thyroid tumor | Fujian Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06934057 | May 2025 → Apr 2028 expected | renal cell carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 4 | NCT03963206 | Sep 2019 → Oct 2021 | hepatocellular carcinoma | Hospices Civils de Lyon | Completed | No outcome recorded |
| Phase 4 | NCT01896479 | Feb 2015 → Jul 2020 overdue | medullary thyroid gland carcinoma | Exelixis | Active not recruiting | Missed primary |
| Phase not applicable3 trials | ||||||
| — | NCT05063058 | Jan 2016 → Nov 2019 | melanoma | Charite University, Berlin, Germany | Completed | No outcome recorded |
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| — | NCT01812668 | Mar 2013 → Jan 2019 | hormone-resistant prostate carcinoma, prostate adenocarcinoma | Barbara Ann Karmanos Cancer Institute | Completed | No outcome recorded |
| Comparator or background therapy24 trials | ||||||
| Phase 1 | NCT05122546 Background | Nov 2021 → Jan 2027 expected | clear cell renal carcinoma, papillary renal cell carcinoma, sarcomatoid renal cell carcinoma | City of Hope Medical Center | Active not recruiting | Missed primary |
| Phase 1 | NCT03798626 Background | May 2019 → Mar 2023 | colorectal cancer, gastroesophageal cancer, renal cell carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02293980 Background | Nov 2014 → Jan 2017 overdue | clear cell renal carcinoma | Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02071862 Background | Feb 2014 → Mar 2019 | gastrointestinal stromal tumor, mesothelioma, non-small cell lung carcinoma, renal cell carcinoma +1 | Calithera Biosciences, Inc | Completed | No outcome recorded |
| Phase 2 | NCT07077161 Comparator | Jan 2026 → Sep 2027 expected | renal cell carcinoma | dr. Tom van der Hulle | Recruiting | No outcome recorded |
| Phase 2 | NCT05773274 Comparator | Jan 2024 → Apr 2029 expected | digestive system neuroendocrine tumor, grade 1/2 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05673824 Background | Jan 2023 → Sep 2025 | poisoning | Fudan University | Completed | No outcome recorded |
| Phase 2 | NCT05012371 Comparator | Feb 2022 → Oct 2027 expected | clear cell renal carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03428217 Background | Apr 2018 → Aug 2020 | clear cell renal carcinoma | Calithera Biosciences, Inc | Completed | Missed primary |
| Phase 2 | NCT01835158 Comparator | Jul 2013 → Apr 2016 | clear cell renal carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT07383441 Background | Jun 2026 → Jan 2033 expected | clear cell renal carcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 3 | NCT07620574 Background | May 2026 → May 2030 expected | colorectal cancer, differentiated thyroid carcinoma, hepatocellular carcinoma, pancreatic neuroendocrine tumor +2 | Exelixis | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07405164 Background | Mar 2026 → Apr 2034 expected | cancer, von Hippel-Lindau disease | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07227402 Comparator | Nov 2025 → Feb 2032 expected | renal cell carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07011719 Background | Sep 2025 → Apr 2028 expected | clear cell renal carcinoma | Arcus Biosciences, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06726421 Background | Sep 2024 → Sep 2030 expected | renal cell carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT04760288 Comparator | Nov 2023 → Oct 2027 | medullary thyroid gland carcinoma | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 3 | NCT04586231 Comparator | Feb 2021 → Feb 2026 overdue | renal cell carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | Mixed |
| Phase 3 | NCT04211337 Comparator | Feb 2020 → May 2023 overdue | medullary thyroid gland carcinoma | Loxo Oncology, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT03729245 Comparator | Dec 2018 → Jan 2022 | renal cell carcinoma | Nektar Therapeutics | Terminated | Missed primary Stop: Business |
| Phase 4 | NCT07028125 Background | Oct 2025 → Oct 2028 expected | renal cell carcinoma | Centre Francois Baclesse | Recruiting | No outcome recorded |
| Phase 4 | NCT06903312 Comparator | Jun 2025 → Oct 2027 expected | renal cell carcinoma | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | No outcome recorded |
| — | NCT02592356 Background | Nov 2015 → Mar 2024 | malignant adrenal gland pheochromocytoma, medullary thyroid gland carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| — | NCT01683110 Background | — | medullary thyroid gland carcinoma | Exelixis | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 210
| Date | Issuer | Release |
|---|---|---|
| 2026-09-28 | Eisai Inc. | Results U.S. FDA Approves WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma With a Clear Cell Component (ccRCC) Approval based on results from the Phase 3 LITESPARK-011 trial evaluating WELIREG in combination with LENVIMA compared to cabozantinib for the treatment of patients with advanced ccRCC following treatment with a PD-1/PD-L1 inhibitor WELIREG plus LENVIMA is the first approved combination of a HIF-2 alpha inhibitor and a multi-targeted VEGFR-TKI for these patients eisai.com ↗
WELIREG plus LENVIMA resulted in a median PFS of 14.6 months (95% CI, 11.1-16.6) versus 10.6 months (95% CI, 9.2-11.1) with cabozantinib. |
| 2026-07-27 | Kura Oncology, Inc. | Results Kura Oncology Reports Durable Clinical Activity of Darlifarnib Plus Cabozantinib in Cabozantinib-Naïve Clear Cell Renal Cell Carcinoma Patients at KCRS 2026 kuraoncology.com ↗
The long-term data compare favorably with benchmarks for advanced RCC, showing robust antitumor activity with darlifarnib plus cabozantinib, as well as evidence of durable benefit. |
| 2026-05-30 | Exelixis | Results Exelixis Announces Results from Subgroup Analysis of Phase 3 CABINET Pivotal Trial Evaluating CABOMETYX® (cabozantinib) in Non-Functional and Functional Neuroendocrine Tumors at ASCO 2026 exelixis.com ↗
In both non-functional and functional NET, cabozantinib delivered substantial improvements in disease control compared to placebo, with median progression-free survival increasing threefold in non-functional NET and more than doubling in functional NET compared to placebo. |
| 2026-04-17 | Kura Oncology, Inc. | Results Kura Oncology Reports Darlifarnib Plus Cabozantinib Demonstrates Robust Activity in Patients With Clear Cell Renal Cell Carcinoma Previously Treated With Cabozantinib kuraoncology.com ↗
In this setting, the combination of darlifarnib and cabozantinib demonstrated robust antitumor activity along with a manageable safety profile as demonstrated in all RCC patients across multiple dose levels, including full dose cabozantinib. |
| 2026-03-02 | Eisai Inc. | Results WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) This is the first positive Phase 3 trial of a multi-targeted tyrosine kinase inhibitor in combination with a HIF-2 alpha inhibitor, the first for patients with RCC whose disease progressed on or after treatment with anti-PD-1/L1 therapy, and the first to improve PFS compared to a modern tyrosine kinase inhibitor Based on these data, the U.S. FDA accepts for review two supplemental New Drug Applications for WELIREG plus LENVIMA in certain previously treated patients with advanced RCC eisai.com ↗ |
| 2026-02-28 | Merck Sharp & Dohme LLC | Results WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) merck.com ↗ |
| 2025-10-28 | Eisai Inc. | Results Merck & Co., Inc., Rahway, NJ, USA and Eisai Announce WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Met Primary Endpoint of Progression-Free Survival (PFS) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma First treatment regimen to demonstrate a statistically significant improvement in PFS for patients whose disease progressed following anti-PD-1/L1 therapy, compared with cabozantinib in Phase 3 study LITESPARK-011 marks the first positive Phase 3 study of a HIF-2 alpha inhibitor in combination with a multi-targeted VEGF tyrosine kinase inhibitor eisai.com ↗
At a pre-specified interim analysis, WELIREG plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in PFS compared to cabozantinib in these patients. |
| 2025-10-18 | Kura Oncology, Inc. | Results Kura Oncology Announces Preliminary Data from Its Farnesyl Transferase Inhibitor (FTI) Programs at the 2025 European Society for Medical Oncology (ESMO) Congress kuraoncology.com ↗ |
| 2025-10-18 | Exelixis | Results Exelixis Announces Results from Subgroup Analysis of CABINET Phase 3 Pivotal Trial Evaluating CABOMETYX® (cabozantinib) in Advanced Lung and Thymic Neuroendocrine Tumors at ESMO 2025 exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced results from a subgroup analysis of the CABINET phase 3 pivotal trial evaluating CABOMETYX® (cabozantinib) versus placebo in patients with previously treated advanced neuroendocrine tumors (NET) originating in the lungs or thymus. |
| 2025-07-24 | Ipsen | Regulatory Cabometyx® approved in the EU for previously treated advanced neuroendocrine tumors ipsen.com ↗
Cabometyx® is the first and only systemic therapy to be approved in the European Union for previously treated unresectable or metastatic neuroendocrine tumors, regardless of tumor site, grade or previous non-somatostatin analogue-based systemic therapy1,2 |
| 2025-07-24 | Exelixis | Regulatory Exelixis’ Partner Ipsen Receives European Commission Approval for CABOMETYX® (cabozantinib) for Patients with Previously Treated Advanced Neuroendocrine Tumors exelixis.com ↗ |
| 2025-06-20 | Ipsen | Regulatory Ipsen receives positive CHMP opinion for Cabometyx® in previously treated advanced neuroendocrine tumors ipsen.com ↗ |
| 2025-06-20 | Exelixis | Regulatory Exelixis’ Partner Ipsen Receives Positive CHMP Opinion for CABOMETYX® (cabozantinib) for Patients with Previously Treated Advanced Neuroendocrine Tumors exelixis.com ↗
The CHMP’s recommendation is a pivotal milestone for our partner Ipsen as they work to bring CABOMETYX to patients in Europe, and we look forward to hearing the European Commission’s decision in the coming months. |
| 2025-06-01 | Arcus Biosciences, Inc. | Results Initial Data from the ARC-20 Study of Casdatifan Plus Cabozantinib Showed Nearly Half of Patients with Metastatic Kidney Cancer Had a Confirmed Response arcusbio.com ↗
Treatment with casdatifan, a HIF-2a inhibitor, plus cabozantinib, a tyrosine kinase inhibitor, showed a confirmed overall response rate (ORR) of 46% in patients who reached a minimum of 12 weeks (two scans) of follow-up |
| 2025-03-26 | Exelixis | Regulatory Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) for Patients with Previously Treated Advanced Neuroendocrine Tumors exelixis.com ↗ |
| 2025-02-15 | Exelixis | Results Exelixis Announces Final Five-Year Follow-up Results from CheckMate -9ER Trial Evaluating CABOMETYX® (cabozantinib) in Combination with Opdivo® (nivolumab) in Patients with Advanced Kidney Cancer at ASCO GU 2025 exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced final results from the phase 3 CheckMate -9ER pivotal trial evaluating CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) versus sunitinib for patients with previously untreated advanced renal cell carcinoma (RCC). |
| 2025-01-24 | Exelixis | Results Exelixis Announces Results from Subgroup Analysis of Phase 3 CABINET Pivotal Study Evaluating Cabozantinib in Advanced Gastrointestinal Neuroendocrine Tumors Presented at ASCO GI 2025 exelixis.com ↗
The analysis showed cabozantinib was associated with an improvement in progression-free survival (PFS) compared with placebo in patients with advanced GI neuroendocrine tumors (NET), which was a subgroup of the epNET cohort. |
| 2025-01-09 | Exelixis | Regulatory Exelixis Provides Update on Oncologic Drugs Advisory Committee Meeting for Cabozantinib (CABOMETYX®) for the Treatment of Patients with Previously Treated Advanced Neuroendocrine Tumors exelixis.com ↗
The sNDA remains under consideration by FDA with a Prescription Drug User Fee Act action date of April 3, 2025. |
| 2024-11-26 | Exelixis | Regulatory Exelixis Provides Regulatory Update Related to Supplemental New Drug Application for Cabozantinib (CABOMETYX®) for the Treatment of Patients with Previously Treated Advanced Neuroendocrine Tumors exelixis.com ↗
will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. |
| 2024-09-16 | Ipsen | Results Final results from CABINET Phase III trial reinforce efficacy benefits of Cabometyx® in advanced neuroendocrine tumors ipsen.com ↗
These data demonstrated a statistically significant reduction in the risk of disease progression or death for Cabometyx versus placebo of 77% (hazard ratio (HR) 0.23) and 62% (HR 0.38) for people living with advanced pNETs and epNETs, respectively. |
| 2024-09-16 | Exelixis | Results Exelixis Announces Final Results from Phase 3 Pivotal CABINET Study Evaluating Cabozantinib in Advanced Neuroendocrine Tumors Presented at ESMO 2024 and Published in New England Journal of Medicine exelixis.com ↗
These data are being presented today at the 2024 European Society for Medical Oncology Congress (ESMO 2024) during the Proffered Paper Session: NETs and Endocrine Tumours at 2:45 p.m. CET and were simultaneously published in the New England Journal of Medicine (NEJM). |
| 2024-09-15 | Ipsen | Results Ipsen provides update on CONTACT-02 Phase III trial in metastatic castration-resistant prostate cancer following final overall survival analysis ipsen.com ↗
At a median follow-up of 24.0 months, these data demonstrated a numerical but not statistically significant improvement in OS for the combination versus a second NHT (hazard ratio: 0.89; 95% confidence interval: 0.72-1.10; P=0.296). |
| 2024-09-15 | Exelixis | Results Exelixis Presents Final Overall Survival Results from Phase 3 CONTACT-02 Pivotal Study Evaluating Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Metastatic Castration-Resistant Prostate Cancer at ESMO 2024 exelixis.com ↗
At a median follow-up of 24.0 months, the final analysis of OS showed a numerical but not statistically significant improvement favoring cabozantinib in combination with atezolizumab (hazard ratio: 0.89; 95% confidence interval: 0.72-1.10; P=0.296). |
| 2024-08-06 | Exelixis | Regulatory Exelixis Announces U.S. Food and Drug Administration (FDA) Accepted the Supplemental New Drug Application for Cabozantinib for Patients with Advanced Neuroendocrine Tumors exelixis.com ↗ |
| 2024-08-06 | Exelixis | Regulatory Exelixis Announces Second Quarter 2024 Financial Results and Provides Corporate Update exelixis.com ↗
On the regulatory front, the FDA accepted the sNDA for cabozantinib in advanced NET, granted standard review and assigned a target action date of April 3, 2025. |
| 2024-01-25 | Exelixis | Results Exelixis Announces Detailed Results of Phase 3 CONTACT-02 Pivotal Trial Evaluating Cabozantinib in Combination with Atezolizumab in Metastatic Castration-Resistant Prostate Cancer Presented at ASCO GU 2024 exelixis.com ↗ |
| 2024-01-22 | Ipsen | Results Latest Phase III trial data investigating Cabometyx® in combination with immunotherapy to be presented at ASCO GU 2024 ipsen.com ↗
Detailed top-line results from Phase III CONTACT-02 trial demonstrated statistically significant progression-free survival benefit for combination of Cabometyx® and atezolizumab in metastatic castration-resistant prostate cancer |
| 2024-01-22 | Bristol-Myers Squibb | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Long-Term Survival Benefits After Four Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma bms.com ↗
Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ: EXEL) today announced four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo ® (nivolumab) in combination with CABOMETYX ® (cabozantinib) vs. sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). |
| 2024-01-22 | Exelixis | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Long-Term Survival Benefits After Four Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma exelixis.com ↗
Superior overall survival (OS) was also observed in patients treated with the combination. |
| 2024-01-17 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at ASCO GU 2024 Showcase Transformative Research in the Treatment of Genitourinary Cancers bms.com ↗
These data demonstrate meaningful, long-term efficacy benefits seen with the combination therapy over sunitinib and reinforce it as a standard of care for previously untreated advanced RCC. |
| 2023-10-22 | Exelixis | Results Detailed Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Neuroendocrine Tumors Presented at ESMO 2023 exelixis.com ↗
The study met the primary objective for each cohort, demonstrating that cabozantinib provided dramatic improvements in median progression-free survival (PFS) for the patients in the pNET and epNET cohorts. |
| 2023-08-24 | Exelixis | Results Exelixis Announces Positive Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Pancreatic and Extra-Pancreatic Neuroendocrine Tumors exelixis.com ↗
Cabozantinib substantially prolonged the time without disease progression or death in both of the trial’s cohorts. |
| 2023-08-22 | Ipsen | Regulatory European Commission approves Cabometyx® in combination with Opdivo® as a first-line treatment for patients living with advanced renal cell carcinoma ipsen.com ↗
today announced that the European Commission (EC) has approved Cabometyx® (cabozantinib) in combination with Bristol Myers Squibb’s Opdivo® (nivolumab) for the first-line treatment of advanced renal cell carcinoma (aRCC). |
| 2023-08-22 | Eli Lilly and Company | Results Lilly's Retevmo® (selpercatinib) Demonstrates Superior Progression-Free Survival Compared to Approved Multikinase Inhibitors in RET-Mutant Medullary Thyroid Cancer lilly.com ↗
The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS). |
| 2023-08-21 | Ipsen | Results Exelixis and Ipsen Announce Positive Results from Phase 3 CONTACT-02 Pivotal Trial Evaluating Cabozantinib in Combination with Atezolizumab in Metastatic Castration-Resistant Prostate Cancer ipsen.com ↗
Cabozantinib in combination with atezolizumab demonstrated a statistically significant reduction in the risk of disease progression or death compared with a second novel hormonal therapy in patients with metastatic castration-resistant prostate cancer |
| 2023-08-21 | Exelixis | Results Exelixis and Ipsen Announce Positive Results from Phase 3 CONTACT-02 Pivotal Trial Evaluating Cabozantinib in Combination with Atezolizumab in Metastatic Castration-Resistant Prostate Cancer exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) and Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the global phase 3 CONTACT-02 pivotal trial met one of two primary endpoints, demonstrating a statistically significant improvement in progression-free survival (PFS) at the primary analysis. |
| 2023-03-02 | Exelixis | Results Exelixis Provides Update on Phase 3 CONTACT-03 Trial Evaluating Cabozantinib in Combination with Atezolizumab in Patients with Previously Treated Advanced Kidney Cancer exelixis.com ↗
the phase 3 CONTACT-03 study did not meet its primary endpoint of progression-free survival (PFS). |
| 2023-02-13 | Ipsen | Results Cabometyx® in combination with nivolumab shows durable survival benefits at over three-years’ follow-up in first-line advanced renal cell carcinoma ipsen.com ↗
Three-year data – with a median follow-up of 44 months – from the Phase III CheckMate -9ER trial demonstrate maintained overall survival benefits with Cabometyx plus nivolumab compared to sunitinib regardless of IMDC risk score1 |
| 2023-02-13 | Bristol-Myers Squibb | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Shows Durable Survival with Over Three Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma bms.com ↗
Data to be featured at ASCO GU 2023 demonstrate continued overall survival, progression-free survival and objective response rate benefits with Opdivo in combination with CABOMETYX compared to sunitinib, regardless of IMDC risk score |
| 2023-02-13 | Exelixis | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Shows Durable Survival with Over Three Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma exelixis.com ↗
Data to be featured at ASCO GU 2023 demonstrate continued overall survival, progression-free survival and objective response rate benefits with Opdivo in combination with CABOMETYX compared to sunitinib, regardless of IMDC risk score |
| 2022-12-08 | Ipsen | Results Ipsen provides update on Phase III CONTACT-01 trial evaluating cabozantinib in combination with atezolizumab in patients with metastatic non-small cell lung cancer previously treated with immunotherapy and chemotherapy ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the CONTACT-01 study did not meet its primary endpoint of overall survival (OS) at the final analysis. |
| 2022-12-08 | Exelixis | Results Exelixis Provides Update on Phase 3 CONTACT-01 Trial Evaluating Cabozantinib in Combination with Atezolizumab in Patients with Metastatic Non-Small Cell Lung Cancer Previously Treated with Immunotherapy and Chemotherapy exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced that the CONTACT-01 study did not meet its primary endpoint of overall survival at the final analysis. |
| 2022-09-07 | Exelixis | Results Exelixis Announces Detailed Results from Phase 3 COSMIC-313 Pivotal Trial in Patients with Previously Untreated Advanced Kidney Cancer at ESMO 2022 exelixis.com ↗
Cabozantinib in combination with nivolumab and ipilimumab significantly reduced the risk of disease progression or death compared with the combination of nivolumab and ipilimumab |
| 2022-07-11 | Exelixis | Results Exelixis Announces Cabozantinib in Combination with Nivolumab and Ipilimumab Significantly Improved Progression-Free Survival in Phase 3 COSMIC-313 Pivotal Trial in Patients with Previously Untreated Advanced Kidney Cancer exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced that COSMIC-313 met its primary endpoint, demonstrating significant improvement in progression-free survival (PFS) at the primary analysis. |
| 2022-05-27 | Ipsen | Results ASCO 2022: New Cabometyx® data show encouraging results in monotherapy and in combination across different tumor types including metastatic non-small cell lung cancer ipsen.com ↗
The data from this analysis showed Cabometyx maintained its PFS vs placebo irrespective of prior lenvatinib and/or sorafenib treatment. |
| 2022-05-26 | Exelixis | Results Exelixis Announces Results from Phase 2 Trial of Cabozantinib in Combination with Pembrolizumab in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma at ASCO 2022 exelixis.com ↗
The trial met its primary endpoint of objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at 54%. |
| 2022-05-26 | Exelixis | Results Exelixis Announces Detailed Results from Urothelial Carcinoma and Non-Small Cell Lung Cancer Cohorts of the COSMIC-021 Trial at ASCO 2022 exelixis.com ↗ |
| 2022-05-18 | Ono Pharmaceutical Co., Ltd. | Regulatory Opdivo® Intravenous Infusion Approved for the Treatment of Previously Untreated or Advanced Renal Cell Carcinoma in Combination with Cabozantinib in Taiwan ono-pharma.com ↗ |
| 2022-05-03 | Ipsen | Regulatory European Commission approves Cabometyx® as a second-line treatment for people living with radioactive iodine-refractory differentiated thyroid cancer ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Commission (EC) has approved the use of Cabometyx® (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy. |
| 2022-05-03 | Exelixis | Regulatory Exelixis’ Partner Ipsen Receives European Commission Approval for CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer exelixis.com ↗
This approval allows for the marketing of CABOMETYX in this indication in all 27 member states of the European Union, Norway, Liechtenstein and Iceland. |
| 2022-03-25 | Ipsen | Regulatory Ipsen receives positive CHMP opinion for Cabometyx® in radioactive iodine-refractory differentiated thyroid cancer ipsen.com ↗ |
| 2022-03-25 | Exelixis | Regulatory Exelixis’ Partner Ipsen Receives Positive CHMP Opinion for CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced that its partner Ipsen received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), for CABOMETYX® (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy. |
| 2022-03-14 | Exelixis | Results Exelixis Announces Final Overall Survival Results from Phase 3 COSMIC-312 Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Patients with Previously Untreated Advanced Liver Cancer exelixis.com ↗
The final analysis showed neither improvement nor detriment in OS for cabozantinib in combination with atezolizumab versus sorafenib. |
| 2022-02-15 | Ono Pharmaceutical Co., Ltd. | Regulatory Opdivo® Intravenous Infusion Approved in South Korea for Two Adjuvant Treatments and Three Combination Treatments ono-pharma.com ↗ |
| 2022-02-15 | Ipsen | Results Cabometyx® in combination with Opdivo® demonstrated continued survival and quality of life benefits with over two years of follow-up in the Phase III CheckMate -9ER trial ipsen.com ↗
Updated results to be presented at ASCO GU 2022 showed sustained efficacy and tumor shrinkage benefits with Cabometyx (cabozantinib) in combination with Opdivo (nivolumab) compared to sunitinib1 |
| 2022-02-14 | Bristol-Myers Squibb | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Continued Survival Benefits with Over Two Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma bms.com ↗
Updated results to be presented at ASCO GU 2022 show sustained efficacy benefits with Opdivo in combination with CABOMETYX compared to sunitinib |
| 2022-02-14 | Exelixis | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Continued Survival Benefits with Over Two Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma exelixis.com ↗
Updated results to be presented at ASCO GU 2022 show sustained efficacy benefits with Opdivo in combination with CABOMETYX compared to sunitinib |
| 2022-01-18 | Exelixis | Results Exelixis Announces Detailed Results for Cabozantinib in Combination with Immunotherapies in Patients with Advanced Colorectal Cancer at ASCO GI 2022 exelixis.com ↗
Cabozantinib in combination with atezolizumab evaluated in cohort 16 of the phase 1b COSMIC-021 trial demonstrated encouraging clinical activity with a manageable safety profile in patients with previously treated metastatic colorectal cancer |
| 2021-11-20 | Exelixis | Results Exelixis Announces Detailed Results from Phase 3 COSMIC-312 Pivotal Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Patients with Previously Untreated Advanced Liver Cancer at ESMO Asia Virtual Oncology Week 2021 exelixis.com ↗
Median PFS was 6.8 months for cabozantinib in combination with atezolizumab (n=250) versus 4.2 months for sorafenib (n=122). |
| 2021-09-20 | Exelixis | Results Exelixis Announces Final Results from Phase 3 COSMIC-311 Pivotal Trial of CABOMETYX® in Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer Presented at ESMO 2021 exelixis.com ↗
At a median follow-up of 10.1 months, the significant improvement in PFS with CABOMETYX was maintained, with consistent benefit in subgroups based on prior treatment. |
| 2021-09-18 | Ipsen | Results ESMO 2021: Cabometyx® demonstrates sustained 78% reduction in risk of disease progression or death in people living with uncommon form of thyroid cancer ipsen.com ↗ |
| 2021-09-18 | Exelixis | Results Exelixis Announces Detailed Phase 1b Results from Cohort 6 of COSMIC-021 Trial in Patients with Metastatic Castration-Resistant Prostate Cancer Presented at ESMO 2021 exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced detailed results from the expanded cohort 6 of the phase 1b COSMIC-021 trial of cabozantinib (CABOMETYX®) in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer (CRPC). |
| 2021-09-17 | Exelixis | Regulatory Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy and who are radioactive iodine-refractory or ineligible. |
| 2021-09-16 | Exelixis | Results Exelixis Announces CABOMETYX® in Combination with OPDIVO® Provides Efficacy Benefits Regardless of Prior Nephrectomy in Patients with Previously Untreated Advanced Renal Cell Carcinoma Based on CheckMate -9ER Analysis Presented at ESMO 2021 exelixis.com ↗
Progression-free survival and objective response rate benefits were observed with combination regimen versus sunitinib regardless of prior nephrectomy status |
| 2021-08-25 | Ono Pharmaceutical Co., Ltd. | Regulatory Ono and Takeda Receive an Approval for Opdivo® (nivolumab) and CABOMETYX® (cabozantinib) Combination Therapy in Japan for Treatment of Unresectable or Metastatic Renal Cell Carcinoma ono-pharma.com ↗ |
| 2021-08-25 | Exelixis | Regulatory Exelixis Announces Partner Takeda and Ono Receive Approval in Japan for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) for the Treatment of Unresectable or Metastatic Renal Cell Carcinoma exelixis.com ↗ |
| 2021-08-05 | Exelixis | Regulatory Exelixis Announces U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer exelixis.com ↗
The FDA granted Priority Review designation and assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 4, 2021. |
| 2021-06-28 | Ipsen | Results Exelixis and Ipsen Announce Cabozantinib in Combination with an Immune Checkpoint Inhibitor Significantly Improved Progression-Free Survival in Phase 3 COSMIC-312 Pivotal Trial in Patients with Previously Untreated Advanced Liver Cancer ipsen.com ↗
cabozantinib in combination with atezolizumab significantly reduced the risk of disease progression or death by 37% compared with sorafenib |
| 2021-06-28 | Exelixis | Results Exelixis and Ipsen Announce Cabozantinib in Combination with an Immune Checkpoint Inhibitor Significantly Improved Progression-Free Survival in Phase 3 COSMIC-312 Pivotal Trial in Patients with Previously Untreated Advanced Liver Cancer exelixis.com ↗
In the analysis of the primary endpoint of PFS in the PFS intent-to-treat population, cabozantinib in combination with atezolizumab significantly reduced the risk of disease progression or death by 37% compared with sorafenib (hazard ratio: 0.63; 99% confidence interval: 0.44-0.91; P=0.0012). |
| 2021-06-07 | Ipsen | Results Exelixis and Ipsen Announce Detailed Results from Phase 3 COSMIC-311 Pivotal Trial of Cabozantinib in Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer Presented at ASCO 2021 ipsen.com ↗
New findings demonstrate the significant progression-free survival benefit seen in the intent-to-treat population was also consistent across subgroups |
| 2021-06-07 | Exelixis | Results Exelixis and Ipsen Announce Detailed Results from Phase 3 COSMIC-311 Pivotal Trial of Cabozantinib in Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer Presented at ASCO 2021 exelixis.com ↗
Results from the trial, which met the co-primary endpoint of significant improvement in progression-free survival (PFS) assessed by blinded independent radiology committee (BIRC), are in press to be published in The Lancet Oncology and have been submitted to the U.S. Food and Drug Administration (FDA). |
| 2021-06-04 | Exelixis | Results Exelixis Announces Quality-Adjusted Survival Benefit Demonstrated in Analysis of Phase 3 CheckMate -9ER Trial of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) in Patients with Previously Untreated Advanced Renal Cell Carcinoma exelixis.com ↗
Patients treated with CABOMETYX in combination with OPDIVO had significantly longer total time without symptoms or toxicity |
| 2021-06-04 | Exelixis | Results Exelixis Announces Positive Phase 2 Results for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) in Patients with Metastatic Non-Clear Cell Renal Cell Carcinoma at ASCO 2021 exelixis.com ↗
Exelixis, Inc. (NASDAQ: EXEL) today announced promising phase 2 results for CABOMETYX® (cabozantinib) in combination with Bristol Myers Squibb’s OPDIVO® (nivolumab) in patients with advanced or metastatic non-clear cell renal cell carcinoma (nccRCC) from an investigator-sponsored trial. |
| 2021-06-04 | Exelixis | Results Exelixis Announces Consistent Efficacy Benefits Across Subgroups of Phase 3 CheckMate -9ER Trial of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-line Treatment for Patients with Advanced Renal Cell Carcinoma exelixis.com ↗
Efficacy benefits with recently approved combination regimen observed regardless of baseline International Metastatic Renal Cell Carcinoma Database Consortium risk status, organ site of metastases or extent of tumor burden |
| 2021-05-24 | Exelixis | Results Exelixis Announces Phase 1b Results from Cohort 6 of COSMIC-021 Trial in Patients with Metastatic Castration-Resistant Prostate Cancer exelixis.com ↗
The combination of cabozantinib and atezolizumab evaluated in cohort 6 of the COSMIC-021 phase 1b trial resulted in objective response rates of 27% and 18% per investigator assessment and Blinded Independent Radiology Committee, respectively |
| 2021-04-14 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives European Commission Approval for Opdivo® (nivolumab) in Combination with Cabometyx® (cabozantinib) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo ® (nivolumab) in combination with Cabometyx ® (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma (RCC). |
| 2021-03-31 | Ipsen | Regulatory European Commission approves Cabometyx® in combination with Opdivo® as a first-line treatment for patients living with advanced renal cell carcinoma ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Commission (EC) has approved Cabometyx® (cabozantinib) in combination with Bristol Myers Squibb’s Opdivo® (nivolumab) for the first-line treatment of advanced renal cell carcinoma (aRCC). |
| 2021-03-31 | Exelixis | Regulatory Exelixis’ Partner Ipsen Receives European Commission Approval for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced its partner Ipsen received approval from the European Commission (EC) for CABOMETYX® (cabozantinib) in combination with OPDIVO® (nivolumab) as a first-line treatment for advanced renal cell carcinoma (RCC). |
| 2021-02-26 | Ipsen | Regulatory Ipsen receives positive CHMP opinion recommending Cabometyx® in combination with Opdivo® as first-line treatment for patients living with advanced renal cell carcinoma ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for Cabometyx® (cabozantinib) in combination with Bristol Myers Squibb’s Opdivo® (nivolumab) for the first-line treatment of advanced renal cell carcinoma (aRCC). |
| 2021-02-26 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo® (nivolumab) in Combination with Cabometyx® (cabozantinib) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma bms.com ↗
has recommended approval of Opdivo ® (nivolumab) in combination with Cabometyx ® (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma (RCC). |
| 2021-02-26 | Exelixis | Regulatory Exelixis’ Partner Ipsen Receives Positive CHMP Opinion for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ: EXEL) today announced that its partner Ipsen received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), for CABOMETYX® (cabozantinib) in combination with OPDIVO® (nivolumab) for the first-line treatment of advanced renal cell carcinoma (RCC). |
| 2021-02-25 | Exelixis | Regulatory Exelixis Announces Breakthrough Therapy Designation Granted to Cabozantinib for the Treatment of Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer exelixis.com ↗ |
| 2021-02-13 | Exelixis | Results Exelixis Highlights Positive Results for CABOMETYX® (cabozantinib) in Patients with Metastatic Papillary Renal Cell Carcinoma in SWOG S1500/PAPMET Study at ASCO GU exelixis.com ↗
Median PFS was 9.0 months (95% CI: 6-12) with CABOMETYX (n=44) versus 5.6 months (95% CI: 3-7) with sunitinib (n=46) (hazard ratio [HR] 0.60; 95% confidence interval [CI]: 0.37 to 0.97; p=0.019). |
| 2021-02-12 | Exelixis | Results Exelixis Announces Final Phase 1 Results from Clinical Trial Sponsored by the National Cancer Institute at ASCO GU for Cabozantinib in Combination with Nivolumab with or without Ipilimumab in Patients with Refractory Metastatic Genitourinary Tumors exelixis.com ↗
The ORR for the 16 patients with previously treated metastatic renal cell carcinoma (RCC) was 62.5%. |
| 2021-02-08 | Ipsen | Results New data from pivotal Phase III CheckMate -9ER trial of Cabometyx® in combination with Opdivo® showed significantly improved QoL benefits and sustained superior efficacy versus sunitinib in patients living with aRCC ipsen.com ↗
With a median follow-up of two years, Cabometyx® in combination with Opdivo® continues to demonstrate superior progression-free survival, overall survival and objective response rate compared to sunitinib1 |
| 2021-02-08 | Bristol-Myers Squibb | Results OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Shows Sustained Survival and Response Rate Benefits as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma in the Phase 3 CheckMate -9ER Trial bms.com ↗
With a median follow-up of two years, OPDIVO in combination with CABOMETYX continues to demonstrate superior progression-free survival, overall survival and objective response rate compared to sunitinib |
| 2021-02-08 | Exelixis | Results OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Shows Sustained Survival and Response Rate Benefits as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma in the Phase 3 CheckMate -9ER Trial exelixis.com ↗
With a median follow-up of two years, OPDIVO in combination with CABOMETYX continues to demonstrate superior progression-free survival, overall survival and objective response rate compared to sunitinib |
| 2021-02-08 | Exelixis | Results Exelixis Announces Positive Findings at ASCO GU for CABOMETYX® (cabozantinib) in Patients with Brain Metastases from Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ: EXEL) today announced results from a retrospective analysis evaluating CABOMETYX® (cabozantinib) activity in brain metastases in patients with renal cell carcinoma (RCC). |
| 2021-02-05 | Ipsen | Results Ipsen to showcase commitment to going beyond traditional outcome measures for patients living with renal cell carcinoma at ASCO GU 2021 ipsen.com ↗
Highlights include extended follow-up and health-related quality of life data from the pivotal CheckMate -9ER trial, further supporting superiority of Cabometyx® (cabozantinib) in combination with Opdivo® (nivolumab) versus sunitinib in first-line advanced RCC1,2 |
| 2021-01-22 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) as First-line Treatment for Patients with Advanced Renal Cell Carcinoma bms.com ↗
was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). |
| 2021-01-22 | Exelixis | Regulatory Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ: EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) for patients with advanced renal cell carcinoma (RCC) as a first-line treatment in combination with OPDIVO® (nivolumab). |
| 2020-12-21 | Exelixis | Results Exelixis Announces Cabozantinib Significantly Improved Progression-Free Survival in COSMIC-311 Phase 3 Pivotal Trial in Patients with Previously Treated Radioiodine-Refractory Differentiated Thyroid Cancer exelixis.com ↗
Cabozantinib reduced the risk of disease progression or death by 78% with a hazard ratio of 0.22 (96% CI 0.13 – 0.36; p<0.0001) at this planned interim analysis. |
| 2020-11-27 | Exelixis | Regulatory Exelixis Announces Partner Takeda Receives Approval in Japan for CABOMETYX® (cabozantinib) for the Treatment of Unresectable Hepatocellular Carcinoma That Has Progressed After Prior Systemic Therapy exelixis.com ↗
Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX® (cabozantinib) in Japan, received approval from the Japanese Ministry of Health, Labor and Welfare to manufacture and market CABOMETYX as a treatment for patients with unresectable hepatocellular carcinoma (HCC) that has progressed after prior systemic therapy. |
| 2020-10-27 | Exelixis | Regulatory Exelixis Announces Takeda and Ono Submit Supplemental Application for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) for the Treatment of Unresectable, Advanced or Metastatic Renal Cell Carcinoma in Japan exelixis.com ↗
Exelixis, Inc. (NASDAQ: EXEL) today announced that Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX® (cabozantinib) in Japan, and Ono Pharmaceutical Co., Ltd. (Ono), have submitted a supplemental application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Manufacturing and Marketing approval of CABOMETYX in combination with OPDIVO® (nivolumab) for the treatment of patients with unresectable, advanced or metastatic renal cell carcinoma (RCC). |
| 2020-10-19 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Accepts for Priority Review Applications for OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Advanced Renal Cell Carcinoma bms.com ↗
The FDA granted Priority Review to both applications and assigned a Prescription Drug User Fee Act (PDUFA) goal date, or target action date, of February 20, 2021. |
| 2020-10-19 | Exelixis | Regulatory U.S. Food and Drug Administration Accepts for Priority Review Applications for OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Advanced Renal Cell Carcinoma exelixis.com ↗
The FDA granted Priority Review to both applications and assigned a Prescription Drug User Fee Act (PDUFA) goal date, or target action date, of February 20, 2021. |
| 2020-09-21 | Exelixis | Results Exelixis Announces Results From Two Renal Cell Carcinoma Cohorts of the COSMIC-021 Trial of Cabozantinib in Combination With Atezolizumab exelixis.com ↗
Exelixis, Inc. (NASDAQ: EXEL) today announced positive phase 1b clinical trial results for the combination of cabozantinib (CABOMETYX®) and atezolizumab (TECENTRIQ®) in patients with locally advanced or metastatic solid tumors. |
| 2020-09-19 | Ipsen | Results ESMO 2020: Cabometyx® (cabozantinib) in combination with Opdivo® (nivolumab) demonstrates significant survival benefits in patients with advanced renal cell carcinoma in pivotal Phase III CheckMate -9ER trial ipsen.com ↗
Cabometyx® in combination with Opdivo® reduced the risk of death by 40% versus sunitinib (HR: 0.60 [98.89% Confidence Interval [CI]: 0.40–0.89]; p= 0.0010; median OS not reached in either arm). |
| 2020-09-19 | Bristol-Myers Squibb | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Significant Survival Benefits in Patients with Advanced Renal Cell Carcinoma in Pivotal Phase 3 CheckMate -9ER Trial bms.com ↗
Opdivo in combination with CABOMETYX showed superior overall survival and doubled median progression-free survival and objective response rate with a favorable safety profile vs. sunitinib |
| 2020-09-19 | Exelixis | Results Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Significant Survival Benefits in Patients with Advanced Renal Cell Carcinoma in Pivotal Phase 3 CheckMate -9ER Trial exelixis.com ↗
In patients receiving Opdivo in combination with CABOMETYX, median progression-free survival (PFS), the trial’s primary endpoint, was doubled compared to those receiving sunitinib alone: 16.6 months vs. 8.3 months, respectively (HR 0.51; 95% CI: 0.41 to 0.64; p<0.0001). |
| 2020-09-14 | Ipsen | Results Ipsen showcases commitment to patient-centric advances in oncology with record number of abstracts to be presented at ESMO 2020 Virtual Congress ipsen.com ↗
Cabometyx® (cabozantinib) in combination with Opdivo® (nivolumab) significantly improved progression-free survival and overall survival with favorable safety profile |
| 2020-08-24 | Exelixis | Regulatory Exelixis Announces Submission of Supplemental New Drug Application to U.S. Food and Drug Administration for CABOMETYX® (cabozantinib) in Combination With Opdivo® (nivolumab) for Advanced Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) for patients with advanced renal cell carcinoma (RCC). |
| 2020-05-19 | Ipsen | Results Ipsen announces publication of first matching-adjusted indirect comparison of Cabometyx® (cabozantinib) versus regorafenib in advanced hepatocellular carcinoma in Advances in Therapy ipsen.com ↗
The MAIC shows that Cabometyx® (cabozantinib) increased median progression-free survival by 80.6% (5.6 months vs. 3.1 months) compared with regorafenib in the 2L treatment of aHCC1 |
| 2020-05-13 | Exelixis | Results Exelixis Announces Results From COSMIC-021 Trial of Cabozantinib in Combination With Atezolizumab in Multiple Advanced Solid Tumor Types exelixis.com ↗
Exelixis, Inc. (NASDAQ: EXEL) today announced phase 1b clinical trial results for the combination of cabozantinib (CABOMETYX®) and atezolizumab (TECENTRIQ®) in patients with locally advanced or metastatic solid tumors. |
| 2020-04-22 | Ipsen | Results Ipsen reports solid sales growth in first quarter 2020 with limited COVID-19 impact ipsen.com ↗ |
| 2020-04-20 | Ipsen | Results Ipsen announces positive topline results from pivotal Phase III CheckMate -9ER trial evaluating CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) in previously untreated advanced renal cell carcinoma ipsen.com ↗
CABOMETYX in combination with Opdivo demonstrates clinically meaningful efficacy results across all endpoints and preliminary assessment showing a favorable safety profile |
| 2020-04-20 | Bristol-Myers Squibb | Results Bristol Myers Squibb and Exelixis Announce Positive Topline Results from Pivotal Phase 3 CheckMate -9ER Trial Evaluating Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Previously Untreated Advanced Renal Cell Carcinoma bms.com ↗ |
| 2020-04-20 | Exelixis | Results Bristol Myers Squibb and Exelixis Announce Positive Topline Results from Pivotal Phase 3 CheckMate -9ER Trial Evaluating Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Previously Untreated Advanced Renal Cell Carcinoma exelixis.com ↗
“The results from the pivotal CheckMate -9ER trial clearly demonstrate the combination of cabozantinib plus nivolumab provides a clinically meaningful benefit in the key efficacy measures of progression-free survival and overall survival for previously untreated kidney cancer patients,” |
| 2020-03-25 | Exelixis | Regulatory Exelixis Announces Partner Takeda Receives Approval in Japan for CABOMETYX® (cabozantinib) Tablets for the Treatment of Curatively Unresectable or Metastatic Renal Cell Carcinoma exelixis.com ↗
Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX® (cabozantinib) in Japan, received approval from the Japanese Ministry of Health, Labor and Welfare |
| 2020-02-10 | Exelixis | Results Exelixis Announces Encouraging Results for Cabozantinib in Combination With Atezolizumab in Metastatic Castration-Resistant Prostate Cancer exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced encouraging results from the metastatic castration-resistant prostate cancer (CRPC) cohort of COSMIC-021, the phase 1b trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in patients with locally advanced or metastatic solid tumors. |
| 2020-01-29 | Exelixis | Regulatory Exelixis Announces Partner Takeda Files New Drug Application in Japan for CABOMETYX® (cabozantinib) for Advanced Hepatocellular Carcinoma exelixis.com ↗ |
| 2020-01-24 | Exelixis | Results Exelixis Announces Results for Combination of Cabozantinib and Nivolumab With or Without Ipilimumab in Advanced Hepatocellular Carcinoma exelixis.com ↗
For the 36 patients treated with the combination of cabozantinib and nivolumab (17 treatment naïve [47%] and 19 with prior sorafenib therapy [53%]), the investigator-assessed objective response rate (ORR) was 19%, and disease control rate (DCR) was 75%. |
| 2019-11-12 | Exelixis | Regulatory Exelixis’ Partner Ipsen Announces Health Canada’s Approval of CABOMETYX® (cabozantinib) Tablets for the Treatment of Patients With Previously Treated Advanced Hepatocellular Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced that its partner Ipsen Biopharmaceuticals Canada Inc. received Health Canada approval of CABOMETYX® (cabozantinib) tablets for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. |
| 2019-09-20 | Ipsen | Results Ipsen to present new data at 13th Annual Conference of the International Liver Cancer Association (ILCA 2019) ipsen.com ↗
Results from a matching-adjusted indirect comparison (MAIC) suggest that cabozantinib provides two additional months of progression-free survival versus regorafenib in the second-line treatment of advanced hepatocellular carcinoma |
| 2019-04-25 | Exelixis | Regulatory Exelixis’ Partner Takeda Announces Filing of New Drug Application in Japan for CABOMETYX® (Cabozantinib) for Advanced Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced that Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of cabozantinib in Japan, has applied to the Japanese Ministry of Health, Labor and Welfare (MHLW) for approval to manufacture and sell CABOMETYX® (cabozantinib) as a treatment for unresectable and metastatic renal cell carcinoma (RCC) in the country. |
| 2019-01-14 | Exelixis | Regulatory Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. |
| 2018-11-15 | Ipsen | Regulatory European Commission approves Ipsen’s Cabometyx® (cabozantinib) for the treatment of hepatocellular carcinoma in adults previously treated with sorafenib ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Commission (EC) has approved Cabometyx® (cabozantinib) 20, 40, 60 mg as a monotherapy for hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib. |
| 2018-11-15 | Exelixis | Regulatory Exelixis’ Partner Ipsen Receives European Commission Approval for CABOMETYX® (cabozantinib) Tablets for the Treatment of Hepatocellular Carcinoma in Adults Previously Treated with Sorafenib exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced that its partner Ipsen received approval from the European Commission (EC) for CABOMETYX® (cabozantinib) tablets as a monotherapy for hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib. |
| 2018-10-22 | Exelixis | Results Exelixis Announces Results from the Dose-Escalation Stage of the Phase 1b COSMIC-021 Study of Cabozantinib in Combination with Atezolizumab in Previously Untreated Advanced Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced results from the dose-escalation stage of the phase 1b COSMIC-021 study of cabozantinib in combination with atezolizumab in previously untreated advanced renal cell carcinoma (RCC). |
| 2018-10-20 | Exelixis | Results Exelixis Announces Results from Two Analyses Evaluating Effect of PD-L1 Expression or Prior Treatment with Checkpoint Inhibitors on Efficacy of Cabozantinib in Patients with Advanced Renal Cell Carcinoma exelixis.com ↗
Treatment with cabozantinib, however, improved PFS and OS compared with everolimus (METEOR) and sunitinib (CABOSUN) in both PD-L1 positive and PD-L1 negative patients. |
| 2018-09-21 | Ipsen | Regulatory Ipsen receives positive CHMP opinion for Cabometyx® (cabozantinib) for the second-line treatment of patients with hepatocellular carcinoma (HCC) ipsen.com ↗ |
| 2018-09-21 | Exelixis | Regulatory Exelixis’ Partner Ipsen Announces Positive CHMP Opinion for CABOMETYX® (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma exelixis.com ↗
The positive CHMP opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. |
| 2018-09-19 | Exelixis | Regulatory Exelixis’ Partner Ipsen Announces Health Canada’s Approval of CABOMETYX® (cabozantinib) Tablets for the Treatment of Adults with Previously Treated Advanced Renal Cell Carcinoma exelixis.com ↗ |
| 2018-07-04 | Ipsen | Results Ipsen announces CELESTIAL phase 3 pivotal trial results in the New England Journal of Medicine ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that The New England Journal of Medicine (NEJM) published results from the CELESTIAL phase 3 pivotal trial of cabozantinib in patients with previously treated advanced hepatocellular carcinoma (HCC). |
| 2018-07-04 | Exelixis | Results Exelixis Announces CELESTIAL Phase 3 Pivotal Trial Results Published in The New England Journal of Medicine exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced that The New England Journal of Medicine (NEJM) published results from the CELESTIAL phase 3 pivotal trial of cabozantinib in patients with previously treated advanced hepatocellular carcinoma (HCC). |
| 2018-06-03 | Exelixis | Results Exelixis Announces Results from Sub-Group Analyses of the Phase 3 Pivotal CELESTIAL Trial of Cabozantinib for Advanced Hepatocellular Carcinoma Presented at ASCO 2018 exelixis.com ↗ |
| 2018-05-29 | Exelixis | Regulatory Exelixis Announces U.S. FDA Accepts Supplemental New Drug Application for CABOMETYX® (cabozantinib) in Previously Treated Advanced Hepatocellular Carcinoma exelixis.com ↗
The FDA has completed its filing review and has determined that the application is sufficiently complete to permit a substantive review. |
| 2018-05-17 | Ipsen | Regulatory European Commission approves Ipsen’s Cabometyx® (cabozantinib) for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Commission (EC) has approved Cabometyx® (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma (aRCC). |
| 2018-05-17 | Exelixis | Regulatory Exelixis’ Partner Ipsen Announces European Commission Approval of CABOMETYX® (Cabozantinib) for Previously Untreated Intermediate- or Poor-Risk Advanced Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (Nasdaq:EXEL) today announced that its partner Ipsen received approval from the European Commission (EC) for CABOMETYX® (cabozantinib) 20 mg, 40 mg and 60 mg for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma (RCC) in the European Union. |
| 2018-03-28 | Ipsen | Regulatory Ipsen announces EMA validation of filing of a new application for additional indication for Cabometyx®, for patients with previously treated advanced Hepatocellular Carcinoma (HCC). ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Medicines Agency (EMA), the European regulatory authority, has validated the filing of a new application for an additional indication for Cabometyx®, for patients with previously treated advanced Hepatocellular Carcinoma (HCC). |
| 2018-03-28 | Exelixis | Regulatory Exelixis’ Partner Ipsen Announces EMA Validation of the Application for a New Indication for CABOMETYX® (cabozantinib) for Previously Treated Advanced Hepatocellular Carcinoma exelixis.com ↗ |
| 2018-03-23 | Ipsen | Regulatory Ipsen receives positive CHMP opinion for Cabometyx® (cabozantinib) for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA) provided a positive opinion for Cabometyx® (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma (aRCC). |
| 2018-03-23 | Exelixis | Regulatory Exelixis’ Partner Ipsen Announces Positive CHMP Opinion for CABOMETYX® (cabozantinib) for Previously Untreated Intermediate- or Poor-Risk Advanced Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced that its partner Ipsen has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), for CABOMETYX® (cabozantinib) 20 mg, 40 mg and 60 mg for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma (RCC). |
| 2018-03-15 | Exelixis | Regulatory Exelixis Submits U.S. Supplemental New Drug Application for CABOMETYX® (Cabozantinib) for Previously Treated Advanced Hepatocellular Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced it has completed the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX® (cabozantinib) tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma (HCC). |
| 2018-02-13 | Exelixis | Results Exelixis Announces Results from a Phase 2 Investigator-Sponsored Trial of Cabozantinib in the First-Line Treatment of Metastatic Radioiodine-Refractory Differentiated Thyroid Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced results from a phase 2 investigator-sponsored trial (IST) of cabozantinib for the first-line treatment of metastatic radioiodine (RAI)-refractory differentiated thyroid carcinoma (DTC). |
| 2018-02-07 | Exelixis | Results Exelixis Announces Updated Phase 1 Trial Results for Cabozantinib in Combination with Nivolumab with or without Ipilimumab in Refractory Genitourinary (GU) Tumors exelixis.com ↗
Results among 19 previously treated metastatic urothelial carcinoma (mUC) patients demonstrated a 42% objective response rate (ORR), 12.8 month median progression-free survival (mPFS), and 77% overall survival (OS) at 12 months, with 7/8 responders progression free with 15.7 months median follow-up |
| 2018-01-16 | Ipsen | Results Ipsen and Exelixis announce phase 3 trial results of cabozantinib demonstrating significant overall survival benefit in patients with previously treated advanced hepatocellular carcinoma ipsen.com ↗
Median OS was 10.2 months with cabozantinib versus 8.0 months with placebo (HR 0.76, 95 percent CI 0.63-0.92; p=0.0049). |
| 2018-01-16 | Exelixis | Results Exelixis and Ipsen Announce Phase 3 Trial Results of Cabozantinib Demonstrating Significant Overall Survival Benefit in Patients with Previously Treated Advanced Hepatocellular Carcinoma exelixis.com ↗
Median OS was 10.2 months with cabozantinib versus 8.0 months with placebo (HR 0.76, 95 percent CI 0.63-0.92; p=0.0049). |
| 2017-12-19 | Exelixis | Regulatory Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) Tablets for Previously Untreated Advanced Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) tablets for the expanded indication of patients with advanced renal cell carcinoma (RCC). |
| 2017-10-16 | Exelixis | Results Exelixis’ Phase 3 CELESTIAL Trial of Cabozantinib Meets Primary Endpoint of Overall Survival in Patients with Advanced Hepatocellular Carcinoma exelixis.com ↗
The independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis. |
| 2017-10-16 | Exelixis | Regulatory Exelixis Announces U.S. FDA Grants Priority Review for CABOMETYX® (Cabozantinib) as a Treatment for Previously Untreated Advanced Renal Cell Carcinoma exelixis.com ↗
The FDA granted Priority Review of the filing and assigned a Prescription Drug User Fee Act (PDUFA) action date of February 15, 2018. |
| 2017-09-09 | Exelixis | Results Exelixis and Ipsen Announce Results from Phase 2 CABOSUN Trial of Cabozantinib versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma at ESMO 2017 exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) and Ipsen (Euronext:IPN; ADR:IPSEY) today announced updated results from the CABOSUN randomized phase 2 trial of cabozantinib in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). |
| 2017-08-16 | Exelixis | Regulatory Exelixis Submits U.S. Supplemental New Drug Application for CABOMETYX® (cabozantinib) for the Treatment of Previously Untreated Advanced Kidney Cancer exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced it has completed the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX® (cabozantinib) tablets as a treatment for patients with previously untreated advanced renal cell carcinoma (RCC). |
| 2017-06-19 | Exelixis | Results Exelixis Announces Independent Radiology Committee Review Confirms Results from CABOSUN, the Phase 2 Trial of Cabozantinib versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma exelixis.com ↗
Per the IRC analysis, cabozantinib demonstrated a clinically meaningful and statistically significant reduction in the rate of disease progression or death as measured by PFS. |
| 2017-03-06 | Exelixis | Regulatory Exelixis' Cabozantinib Granted Orphan Drug Designation for the Treatment of Hepatocellular Carcinoma exelixis.com ↗
Exelixis, Inc. (Nasdaq: EXEL) today announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to cabozantinib for the treatment of hepatocellular carcinoma (HCC). |
| 2017-02-17 | Exelixis | Results Exelixis Announces Phase 1 Trial Results for Cabozantinib in Combination with Nivolumab with or without Ipilimumab in Refractory Metastatic Urothelial Carcinoma and Other Genitourinary Tumors exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced results from a phase 1 trial of cabozantinib in combination with either nivolumab or nivolumab plus ipilimumab in patients with refractory genitourinary tumors. |
| 2016-10-10 | Exelixis | Results Exelixis Announces Positive Results from Phase 2 CABOSUN Trial of Cabozantinib Versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma Presented at ESMO 2016 exelixis.com ↗
In CABOSUN, with a median follow-up of 20.8 months, cabozantinib demonstrated a clinically meaningful and statistically significant 31 percent reduction in the rate of disease progression or death [HR 0.69, 95% CI (0.48-0.99), one-sided P=0.012]. |
| 2016-10-07 | Exelixis | Results Exelixis Announces Phase 1 Trial Results for Cabozantinib in Combination with Nivolumab in Advanced Genitourinary Tumors exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced results from a phase 1 trial of cabozantinib in combination with nivolumab in patients with previously treated genitourinary tumors. |
| 2016-09-14 | Exelixis | Regulatory European Commission Approves CABOMETYX™ (cabozantinib) Tablets for the Treatment of Advanced Renal Cell Carcinoma Following VEGF-Targeted Therapy exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced that the European Commission (EC) has approved CABOMETYX™ (cabozantinib) tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. |
| 2016-07-22 | Exelixis | Regulatory Ipsen and its Partner Exelixis Receive Positive CHMP Opinion for Cabometyx™ (Cabozantinib) for the Treatment of Advanced RCC in Adults Following Prior VEGF-Targeted Therapy exelixis.com ↗
CHMP recommends approval of Cabometyx™ (cabozantinib) for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy based on the results of a large, randomized Phase 3 trial, METEOR |
| 2016-06-06 | Exelixis | Results Exelixis and Its Partner Ipsen Announce Positive Overall Survival Results from Subgroup Analyses of Phase 3 Trial of CABOMETYX™ (cabozantinib) Tablets in Advanced Renal Cell Carcinoma at 2016 ASCO Annual Meeting exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) and Ipsen (Euronext: IPN; ADR: IPSEY) today announced the presentation of positive data from subgroup analyses of the pivotal METEOR trial comparing CABOMETYX™ (cabozantinib) tablets with everolimus in 658 patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. |
| 2016-06-05 | Exelixis | Results Exelixis and Its Partner Ipsen Announce Phase 3 Trial Results of CABOMETYX™ (Cabozantinib) Tablets Demonstrating Significant Overall Survival Benefit for Previously Treated Patients with Advanced Renal Cell Carcinoma Presented at ASCO exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) and Ipsen (Euronext:IPN; ADR:IPSEY) today announced overall survival (OS) results from the phase 3 METEOR trial of CABOMETYX™ (cabozantinib) tablets in patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. |
| 2016-05-23 | Exelixis | Results Exelixis Announces Results from Randomized Phase 2 Trial CABOSUN Demonstrate Cabozantinib Significantly Improved Progression-Free Survival versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma exelixis.com ↗
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for cabozantinib compared with sunitinib in patients with advanced intermediate- or poor-risk RCC. |
| 2016-04-25 | Exelixis | Regulatory Exelixis Announces FDA Approval of CABOMETYX™ (Cabozantinib) Tablets for Patients with Advanced Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) has approved CABOMETYX™ (cabozantinib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. |
| 2016-04-20 | Exelixis | Results Exelixis-Discovered Compounds to Be Featured in 18 Presentations at 2016 ASCO Annual Meeting exelixis.com ↗ |
| 2016-02-29 | Exelixis | Results Exelixis Announces Fourth Quarter and Full Year 2015 Financial Results and Provides Corporate Update exelixis.com ↗
METEOR Trial of Cabozantinib in Advanced Renal Cell Carcinoma Delivers Positive Overall Survival Results. |
| 2016-02-01 | Exelixis | Results Exelixis Announces Positive Overall Survival Results from METEOR, the Phase 3 Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma exelixis.com ↗
In a second interim analysis for OS, a secondary endpoint of the trial, the results showed a highly statistically significant and clinically meaningful increase in OS for patients randomized to cabozantinib as compared to everolimus. |
| 2016-01-28 | Exelixis | Regulatory Exelixis Announces U.S. FDA Deems New Drug Application Sufficiently Complete and Grants Priority Review for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma exelixis.com ↗
The FDA granted Priority Review to the filing and assigned a Prescription Drug User Fee Act action date of June 22, 2016. |
| 2016-01-28 | Exelixis | Regulatory Exelixis Announces European Medicines Agency Acceptance of Marketing Authorization Application for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. |
| 2016-01-11 | Exelixis | Regulatory Exelixis Submits Marketing Authorization Application in the European Union for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced that it has submitted a Marketing Authorization Application (MAA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy to the European Medicines Agency (EMA). |
| 2016-01-04 | Exelixis | Results Exelixis Announces Positive Results From Subgroup Analyses of the METEOR Phase 3 Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma to be Presented at ASCO 2016 Genitourinary Cancers Symposium exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced the presentation of positive data from subgroup analyses of METEOR, the phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI). |
| 2015-12-23 | Exelixis | Regulatory Exelixis Completes Submission of New Drug Application for Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced that it has completed the submission of its rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. |
| 2015-10-22 | Exelixis | Regulatory Exelixis Initiates Rolling Submission of U.S. New Drug Application for Cabozantinib for the Treatment of Advanced Kidney Cancer exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced the company has initiated submission of its rolling New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for cabozantinib for the treatment of advanced renal cell carcinoma (RCC) patients who have received one prior therapy. |
| 2015-09-25 | Exelixis | Results Exelixis Announces Positive Results from METEOR Phase 3 Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma Presented at European Cancer Congress 2015 exelixis.com ↗
Cabozantinib met the primary endpoint of improving progression-free survival as compared to everolimus |
| 2015-08-24 | Exelixis | Regulatory FDA Grants Breakthrough Therapy Designation to Exelixis’ Cabozantinib for the Treatment of Renal Cell Carcinoma in Patients Who Received One Prior Therapy exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy Designation to cabozantinib, Exelixis’ lead compound, as a potential treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. |
| 2015-07-20 | Exelixis | Results Exelixis Announces Positive Top-Line Results from METEOR, the Phase 3 Pivotal Trial of Cabozantinib versus Everolimus in Patients with Metastatic Renal Cell Carcinoma exelixis.com ↗
The trial met its primary endpoint of demonstrating a statistically significant increase in progression-free survival (PFS) in the first 375 randomized patients as determined by an independent radiology committee (IRC). |
| 2015-05-31 | Exelixis | Results Exelixis Announces Positive Results from Phase 2 Trial of Cabozantinib in Patients with EGFR Wild-Type Non-Small Cell Lung Cancer exelixis.com ↗
Study E1512 met its primary endpoint, demonstrating significant increases in progression-free survival (PFS) for cabozantinib and the combination of cabozantinib plus erlotinib when individually compared to the erlotinib arm. |
| 2015-05-31 | Exelixis | Results Exelixis Announces Positive Results from Phase 2 Investigator-Sponsored Trial of Cabozantinib in RET-Rearranged Non-Small Cell Lung Cancers exelixis.com ↗
The objective response rate (ORR) was 38% (6/16), with a median duration of response of 8 months. |
| 2015-04-09 | Exelixis | Regulatory Exelixis’ Cabozantinib Granted Fast Track Designation by FDA For Advanced Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation to cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. |
| 2014-12-01 | Exelixis | Results Exelixis Announces Results from the COMET-2 Pivotal Phase 3 Trial of Cabozantinib in Men With Metastatic Castration-Resistant Prostate Cancer exelixis.com ↗
The trial did not meet its primary endpoint of alleviation of bone pain, as determined by comparing the percentage of patients in the two treatment arms who achieved a pain response at Week 6 that was confirmed at Week 12 without increase in narcotic medication. |
| 2014-11-04 | Exelixis | Results Exelixis Announces Positive Top-Line Results From a Phase 2 Trial of Cabozantinib and Erlotinib in Patients With EGFR Wild-Type Non-Small Cell Lung Cancer exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced positive top-line results from a randomized phase 2 trial of cabozantinib and erlotinib alone or in combination as second- or third-line therapy in patients with stage IV EGFR wild-type non-small cell lung cancer (NSCLC). |
| 2014-09-01 | Exelixis | Results Exelixis Announces Results from the COMET-1 Phase 3 Pivotal Trial of Cabozantinib in Men with Metastatic Castration-Resistant Prostate Cancer exelixis.com ↗
The trial did not meet its primary endpoint of demonstrating a statistically significant increase in overall survival (OS) for patients treated with cabozantinib as compared to prednisone. |
| 2014-03-25 | Exelixis | Regulatory Exelixis Receives Approval for COMETRIQ® (Cabozantinib) in the European Union for Treatment of Progressive, Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced that the European Commission has approved COMETRIQ® (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC). |
| 2013-12-19 | Exelixis | Regulatory COMETRIQ® (cabozantinib) Receives Positive Opinion from European Committee for Medicinal Products for Human Use for Progressive, Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion of the Marketing Authorization Application (MAA) for COMETRIQ® (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC). |
| 2013-06-02 | Exelixis | Results Exelixis Presents COMETRIQ™ (cabozantinib) Clinical Trial Data in Patients with Progressive, Metastatic Medullary Thyroid Cancer exelixis.com ↗
Long-term follow-up of a phase 1 trial (Abstract #6090) shows that 30% of progressive, metastatic MTC patients treated with COMETRIQ experienced disease control (DC) and have remained progression-free for more than 2 years. |
| 2013-06-01 | Exelixis | Results Exelixis Announces Presentation of Updated Phase 2 Data for Cabozantinib in Men with Heavily-Pretreated Metastatic Castration-Resistant Prostate Cancer exelixis.com ↗
Median overall survival was 10.8 months in a patient population in which 73% of patients had received two or more prior therapies including docetaxel and abiraterone, enzalutamide, and/or cabazitaxel. |
| 2013-04-09 | Exelixis | Results Preclinical Data Presented at AACR Describe a Mechanism of Action of Cabozantinib in a Prostate Cancer Bone Metastasis Model exelixis.com ↗
Exelixis, Inc. (NASDAQ: EXEL) announced the presentation of preclinical data that provide insight into the mechanism of action of its lead compound, cabozantinib, with respect to its activity against prostate cancer tumors that have metastasized to the bone. |
| 2012-11-29 | Exelixis | Regulatory FDA Approves COMETRIQ™ (Cabozantinib) for Treatment of Progressive, Metastatic Medullary Thyroid Cancer exelixis.com ↗
Exelixis, Inc. (NASDAQ: EXEL) today announced that the U.S. Food and Drug Administration (FDA) has approved COMETRIQ™ (cabozantinib) for the treatment of progressive, metastatic medullary thyroid cancer (MTC). |
| 2012-11-29 | Exelixis | Regulatory Exelixis Announces EMA Acceptance of Marketing Authorization Application For COMETRIQ™ (cabozantinib) exelixis.com ↗
Exelixis, Inc. (NASDAQ: EXEL) today announced the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for COMETRIQ™ (cabozantinib) for the proposed indication of treatment of progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). |
| 2012-09-30 | Exelixis | Results Preliminary Phase 1 Data for Cabozantinib in Japanese Patients Presented at ESMO 2012 exelixis.com ↗
Dose-limiting toxicity of Grade 3 hypertension was reported in 2 patients, and the recommended phase 2 dose is 60 mg daily. |
| 2012-09-30 | Exelixis | Results Interim Data for Cabozantinib 40 mg Dose Cohort in Metastatic Castration-Resistant Prostate Cancer Presented at ESMO 2012 Congress exelixis.com ↗
The data suggest that the 40 mg daily dose has activity with respect to a number of key metrics, including bone and soft tissue responses, as well as changes in pain scores and narcotic use. |
| 2012-08-29 | Exelixis | Regulatory Exelixis Provides Update on ODAC Panel for Cabozantinib exelixis.com ↗
As a result, the Company does not anticipate a discussion of the NDA by ODAC. |
| 2012-07-30 | Exelixis | Regulatory FDA Grants Priority Review for Cabozantinib in Medullary Thyroid Cancer exelixis.com ↗
The FDA also granted priority review designation to the NDA for cabozantinib. |
| 2012-06-05 | Exelixis | Results Cabozantinib Demonstrates Durable Effects in Bone and Soft Tissue in Advanced Prostate Cancer exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today reported positive updated interim data from an ongoing phase 2 trial of cabozantinib in men with metastatic castration-resistant prostate cancer (CRPC) and bone metastases. |
| 2012-06-04 | Exelixis | Results Cabozantinib Meets Primary Endpoint of Progression Free Survival in Phase 3 Pivotal Trial in Medullary Thyroid Cancer exelixis.com ↗
The trial, known as EXAM, met its primary endpoint of improving progression-free survival (PFS), with patients in the cabozantinib arm achieving a median PFS of 11.2 months compared with 4.0 months for patients in the placebo arm. |
| 2012-06-02 | Exelixis | Results Cabozantinib Demonstrates Evidence of Anti-Tumor Effects in Heavily Pretreated Patients with Hepatocellular Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today reported positive updated interim data from the cohort of hepatocellular carcinoma (HCC) patients participating in the ongoing phase 2 randomized discontinuation trial (RDT) of cabozantinib. |
| 2012-06-02 | Exelixis | Results Cabozantinib Demonstrates Encouraging Activity in Patients with Heavily Pretreated Metastatic Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today reported positive updated interim data from a cohort of heavily pretreated patients with metastatic refractory renal cell carcinoma (RCC) participating in an ongoing phase 1b trial of cabozantinib. |
| 2012-05-30 | Exelixis | Regulatory Exelixis Completes Submission of New Drug Application for Cabozantinib for the Treatment of Medullary Thyroid Cancer exelixis.com ↗
Exelixis, Inc. (NASDAQ: EXEL) today announced that it has completed the filing of its rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). |
| 2012-02-03 | Exelixis | Results Cabozantinib Shows Encouraging Activity in Heavily Pretreated Patients With Advanced Renal Cell Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today reported preliminary data from a cohort of heavily pretreated patients with metastatic refractory renal cell carcinoma (RCC) participating in an ongoing phase 1b trial of cabozantinib. |
| 2012-01-20 | Exelixis | Results Exelixis Reports Positive Preliminary Phase 2 Cabozantinib Data in Patients with Hepatocellular Carcinoma exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today reported positive preliminary data from the cohort of hepatocellular carcinoma (HCC) patients participating in the ongoing phase 2 randomized discontinuation trial (RDT) of cabozantinib. |
| 2011-12-07 | Exelixis | Results Exelixis' Cabozantinib Shows Encouraging Clinical Activity in Patients With Metastatic Breast Cancer exelixis.com ↗
The Week 12 disease control rate (week 12 SD or PR) was 48%. |
| 2011-11-12 | Exelixis | Results Preliminary Data Demonstrate that 40 mg Daily Dose of Cabozantinib Yields a High Rate of Bone Scan Response in mCRPC exelixis.com ↗
The 40 mg dose was also associated with improved tolerability compared with the 100 mg daily dose used in the ongoing phase 2 randomized discontinuation trial of cabozantinib. |
| 2011-11-12 | Exelixis | Results Exelixis' Cabozantinib Phase 2 Data Demonstrate Reduction in Bone Pain and Narcotic Analgesic Use in Patients with Previously Treated mCRPC exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today reported interim data on pain relief and related reduction in narcotic analgesic use with cabozantinib in castration-resistant prostate cancer (CRPC) patients with bone metastases. |
| 2011-10-24 | Exelixis | Results Exelixis' Cabozantinib Meets Primary Endpoint in Phase 3 Clincial Trial for Medullary Thyroid Cancer exelixis.com ↗
The trial met its primary endpoint of improving progression-free survival (PFS) compared with placebo and substantially exceeded the threshold of a 75% increase in PFS originally assumed when the trial was designed. |
| 2011-06-06 | Exelixis | Results Exelixis' Cabozantinib Phase 2 Data Demonstrate Encouraging Clinical Activity in Patients with Metastatic Castration-Resistant Prostate Cancer exelixis.com ↗ |
| 2011-06-05 | Exelixis | Results Exelixis' Cabozantinib Demonstrates Broad Clinical Activity in Multiple Tumor Types exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today reported updated interim data from an ongoing phase 2 adaptive randomized discontinuation trial (RDT) of cabozantinib in patients with advanced solid tumors. |
| 2011-06-04 | Exelixis | Results Exelixis' Cabozantinib Demonstrates Encouraging Clinical Activity in Patients with Metastatic Ovarian Cancer exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) reported longer follow-up data from a fully enrolled cohort of patients with advanced epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube carcinoma treated with cabozantinib (XL184) in an ongoing phase 2 adaptive randomized discontinuation trial. |
| 2011-05-23 | Exelixis | Results Data From a Phase 1 Clinical Trial of Exelixis' Cabozantinib Published in the Journal of Clinical Oncology exelixis.com ↗
The publication includes safety data from all 85 patients enrolled in the phase 1 cabozantinib study, and also includes tumor response, genotyping, pharmacokinetic, and pharmacodynamic biomarker data for the 37 patients in the study with medullary thyroid cancer (MTC). |
| 2011-02-17 | Exelixis | Results Cabozantinib (XL184) Phase 2 Data Demonstrate Encouraging Clinical Activity in Patients with Castration-Resistant Prostate Cancer exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today reported updated interim data from the cohort of patients with metastatic castration-resistant prostate cancer (CRPC) treated with cabozantinib (XL184) in an ongoing phase 2 adaptive randomized discontinuation trial. |
| 2011-01-10 | Exelixis | Regulatory Exelixis' XL184 Granted Orphan Drug Designation and Assigned the Generic Name Cabozantinib exelixis.com ↗
Exelixis, Inc. (Nasdaq:EXEL) today announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to XL184 for treatment of follicular, medullary, and anaplastic thyroid carcinoma, and metastatic or locally advanced papillary thyroid cancer. |
| 2010-11-18 | Exelixis | Results Exelixis Reports Promising Interim Data From Patients With Ovarian Cancer Treated With XL184 exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today reported interim data from the cohort of patients with advanced epithelial ovarian cancer, primary peritoneal, or fallopian tube carcinoma treated with XL184 in an ongoing phase 2 adaptive randomized discontinuation trial (RDT). |
| 2010-11-18 | Exelixis | Results Exelixis Reports Promising Interim Data from Patients with Castration-Resistant Prostate Cancer Treated with XL184 exelixis.com ↗
Nineteen of 20 patients (95%) achieved either complete or partial resolution of lesions on bone scanby independent review, with most resolving at the first post-baseline assessment at 6 weeks. |
| 2010-05-20 | Exelixis | Results Exelixis Reports Updated Phase 2 Data for XL184 in Patients With Recurrent Glioblastoma to Be Presented at ASCO exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today reported promising interim data from an ongoing phase 2 trial of XL184 in patients with recurrent glioblastoma (GB), the most common and aggressive form of brain cancer. |
| 2010-05-20 | Exelixis | Results Exelixis Reports Long-Term Phase 1 Results in a Cohort of Medullary Thyroid Cancer Patients Treated With XL184 to be Presented at ASCO exelixis.com ↗
As of the data cut-off date of April 16, 2010, 10 of 35 patients (29%) with measurable disease had a confirmed partial response (PR) which corresponds to tumor shrinkage of greater-than or equal to 30% on at least two post-baseline scans. |
| 2010-05-20 | Exelixis | Results Exelixis Reports Encouraging Interim Data From an Ongoing Phase 1b/2 Study of XL184 With or Without Erlotinib in Patients With Non-Small Lung Cancer to be Presented at ASCO exelixis.com ↗
Exelixis, Inc. (NASDAQ:EXEL) today reported interim data from an ongoing Phase 1b/2 study of XL184 in patients with non-small cell lung cancer (NSCLC). |
| 2010-05-20 | Exelixis | Results Exelixis Reports Encouraging Interim Data from an Ongoing Adaptive Randomized Discontinuation Trial of XL184 in Patients With Solid Tumors to be Presented at ASCO exelixis.com ↗ |
| 2009-10-23 | Bristol-Myers Squibb | Results Exelixis and Bristol-Myers Squibb Report New Phase 2 Data for XL184 in Patients With the Most Common and Aggressive Form of Brain Cancer bms.com ↗
Exelixis, Inc. (Nasdaq:EXEL) and Bristol-Myers Squibb Company (NYSE:BMY) today reported updated phase 2 clinical data which show that XL184 demonstrated activity in patients with glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. |
| 2009-10-23 | Exelixis | Results Exelixis and Bristol-Myers Squibb Report New Phase 2 Data for XL184 in Patients With the Most Common and Aggressive Form of Brain Cancer exelixis.com ↗
today reported updated phase 2 clinical data which show that XL184 demonstrated activity in patients with glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. |
| 2009-05-31 | Bristol-Myers Squibb | Results Exelixis and BMS Report Phase 2 Data to Be Presented at ASCO for XL184 in Patients with Previously Treated Glioblastoma Multiforme bms.com ↗
By ITT analysis, 7 of 35 (20%) of the antiangiogenic naïve patients had a confirmed partial response. |
| 2009-05-31 | Exelixis | Results Exelixis and BMS Report Phase 2 Data to Be Presented at ASCO for XL184 in Patients with Previously Treated Glioblastoma Multiforme exelixis.com ↗
By ITT analysis, 7 of 35 (20%) of the antiangiogenic naïve patients had a confirmed partial response. |
All press releases naming this drug 291 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 291 releases opens the full record — a long page | ||
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 266 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cabozantinib | “Medical therapy is the continuation of the immune-based combo for mRCC including one of the available options among axitinib + pembrolizumab or cabozantinib + nivolumab or...” NCT06903312 ↗257“Treatment period: Therapeutic agents were selected according to clinical routine, including but not limited to Sorafenib, Lenvatinib, Donafenib, Regorafenib, Apatinib and Cabozantinib.” NCT05673824 ↗ “In this study, Cabozantinib (VEGF inhibitor) and Dostarlimab (immunotherapeutic drug) will be admnistered as a combination to patients with recurrent gynecologic carcinosarcoma.” NCT05559879 ↗ “Safety Study of XL184 (Cabozantinib) in Combination With Temozolomide and Radiation Therapy in the Initial Treatment of Adults With Glioblastoma” NCT00960492 ↗ “XL184 (cabozantinib) is a potent inhibitor of MET, vascular endothelial growth factor receptor 2 (VEGFR2), and RET” PMID 21606412 ↗ May 2011 “A Study of XL184 (Cabozantinib) With or Without Erlotinib in Subjects With Non-Small Cell Lung Cancer (NSCLC)” NCT00596648 ↗ “Treatment with tyrosine kinase inhibitors consists of standard-of-care Lenvatinib or Cabozantinib.” NCT05620771 ↗ “A phase I study of cabozantinib (XL184) in patients with renal cell cancer.” PMID 24827131 ↗ May 2014 “Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer” NCT00704730 ↗ “MET Inhibitors (Crizotinib 250 mg 2/d, or Cabozantinib 60mg/d)” NCT05063058 ↗ “CB-839 in combination with standard dose cabozantinib” NCT02071862 ↗ |
| Known as | BMS-907351 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01018745 ↗ |
| Known as | BMS-907351 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105717 ↗ |
| Known as | Cabo | “Cabozantinib (Cabo)” NCT04300140 ↗ |
| Known as | cabometyx | “cabozantinib tablets (Cabometyx®) once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw for a maximum duration of 2 years.” NCT03729297 ↗3“Cabozantinib is the generic for the trade chemotherapy drug CABOMETYX™ (cabozantinib).” NCT06377722 ↗ “Cabozantinib (Cabometyx) 60, 40 and 20 mg” NCT06535737 ↗ |
| Known as | CABOZANTINIB (BMS-907351) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105717 ↗ |
| Known as | Cabozantinib malate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105717 ↗ |
| Known as | Cabozantinib S-malate | “Cabozantinib S-malate is a vascular endothelial growth factor receptor 2, c-MET, and RET multitargeted tyrosine kinase inhibitor that has antiangiogenic and antitumorigenic...” PMID 25427282 ↗ Feb 201516“I. Compare the progression-free survival rate at 4 months (PFS4) of patients with ocular melanoma treated with cabozantinib-s-malate (cabozantinib) or temozolomide (or dacarbazine).” NCT01835145 ↗ “safety of cabozantinib S-malate (cabozantinib) in combination with atezolizumab in patients with mCRPC with non-measurable disease” NCT05168618 ↗ “cabozantinib s-malate (cabozantinib) combined with nivolumab and ipilimumab in the first or second-line (and beyond) setting” NCT03866382 ↗ “To evaluate the effect of cabozantinib (cabozantinib S-malate) in combination with avelumab on overall survival (OS)” NCT05092958 ↗ “To evaluate the antitumor activity of cabozantinib s-malate (cabozantinib) for Ewing sarcomas” NCT02243605 ↗ “cabozantinib (cabozantinib S-malate) can significantly improve progression-free survival” NCT03375320 ↗ “Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28.” NCT01935934 ↗ “Patients receive cabozantinib-s-malate orally (PO) daily on days 1-28.” NCT01811212 ↗ “cabozantinib S-malate (cabozantinib) orally (PO) once daily (QD)” NCT05327738 ↗ “XL184 (cabozantinib) (cabozantinib S-malate)” NCT01709435 ↗ |
| Known as | CABOZANTINIBCT-XL184COMETRIQXL184C3627 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105717 ↗ |
| Known as | COMETRIQ | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105717 ↗ |
| Known as | NSC #761968 | “A Phase II Trial of Cabozantinib (XL-184) (NSC #761968) in Women With Recurrent, Clear Cell Carcinoma of the Ovary, Fallopian Tube, or Peritoneum” NCT02315430 ↗ |
| Known as | XL-184 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105717 ↗ |
| Known as | XL184 | “A Phase II, Randomized, Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics (PK) of Maintenance Cabozantinib (XL184) Plus Best Supportive Care (BSC) Versus...” NCT06341712 ↗22“The purpose of this phase II study is to find out what effects cabozantinib (XL184) has, good and/or bad, in patients whose tumors one of the following gene changes RET, ROS1,...” NCT01639508 ↗ “A Phase 3, Randomized, Double-blind, Controlled Trial of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic...” NCT01522443 ↗ “Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.” NCT05052723 ↗ “A Phase I Trial of Cabozantinib (XL184) in Combination With High-dose Ifosfamide in Adults and Children With Relapsed/Refractory Sarcomas (CaIRS Trial)” NCT06156410 ↗ “An Open-Label, Expanded Access Study of Cabozantinib (XL184) in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer” NCT01683110 ↗ “A Phase II Trial of Cabozantinib (XL-184) (NSC #761968) in Women With Recurrent, Clear Cell Carcinoma of the Ovary, Fallopian Tube, or Peritoneum” NCT02315430 ↗ “A Phase 2 Study of Cabozantinib (XL184), a Dual Inhibitor of MET and VEGFR, in Patients With Metastatic Refractory Soft Tissue Sarcoma” NCT01755195 ↗ “Activity of XL184 (Cabozantinib), an oral tyrosine kinase inhibitor, in patients with medullary thyroid cancer.” PMID 21606412 ↗ May 2011 “Niraparib in Combination with Cabozantinib (XL184) in Patients with Advanced Urothelial Cancer (NICARAGUA)” NCT03425201 ↗ “A Phase II Study of Cabozantinib (XL184) in Patients With Advanced/Metastatic Urothelial Carcinoma” NCT01688999 ↗ |
| Known as | XL184,BMS-907351 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105717 ↗ |
| Action | Inhibit | “XL184 (cabozantinib) is a potent inhibitor of MET, vascular endothelial growth factor receptor 2 (VEGFR2), and RET” PMID 21606412 ↗ May 2011 |
| Modality | Small molecule | “XL184 (Cabozantinib), an oral tyrosine kinase inhibitor” PMID 21606412 ↗ May 2011 |
| Route | Oral | “XL184 Administered Orally” NCT00215605 ↗ |
| Target | MET | “XL184 (cabozantinib) is a potent inhibitor of MET, vascular endothelial growth factor receptor 2 (VEGFR2), and RET” PMID 21606412 ↗ May 2011 |
| Target | RET | “XL184 (cabozantinib) is a potent inhibitor of MET, vascular endothelial growth factor receptor 2 (VEGFR2), and RET” PMID 21606412 ↗ May 2011 |