Drugs / Axitinib
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed renal cell adenocarcinoma 3 milestones | |||||
| Filed | EU (EMA) | BAVENCIO | renal cell adenocarcinoma | 2019-03-08 | “EMA has validated for review the Type II variation application for BAVENCIO ® (avelumab) in combination with INLYTA® (axitinib)*” pfizer.com ↗ |
| Filed | US (FDA) | INLYTA | renal cell adenocarcinoma | 2019-02-11 | “FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for BAVENCIO ® (avelumab) in combination with INLYTA ® (axitinib)*” pfizer.com ↗ “FDA accepted for Priority Review the supplemental Biologics License Application (sBLA) for BAVENCIO in combination with INLYTA” prnewswire.com ↗ |
| Filed | Japan (PMDA) | INLYTA | renal cell adenocarcinoma | 2019-01-30 | “A supplemental application for BAVENCIO in combination with axitinib in unresectable or metastatic RCC was submitted in Japan in January 2019.” pfizer.com ↗ “A supplemental application for BAVENCIO in combination with axitinib in unresectable or metastatic RCC was submitted in Japan in January 2019.” pfizer.com ↗ “A supplemental application for BAVENCIO+INLYTA in unresectable or metastatic RCC was submitted in Japan on January 30, 2019.” prnewswire.com ↗ “A supplemental application for BAVENCIO+INLYTA in unresectable or metastatic RCC was submitted in Japan on January 30, 2019.” pfizer.com ↗ “A supplemental application for the combination in unresectable or metastatic RCC has also been submitted in Japan.” pfizer.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | INLYTA | — | 2020-06-04 – 2022-09-22 | fda.gov ↗ |
| Approved | EU (EMA) | Inlyta | — | 2012-09-03 | europa.eu ↗ |
| Approved | US (FDA) | INLYTA | — | 2012-01-27 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05553782 | Nov 2023 → Apr 2029 expected | head and neck squamous cell carcinoma, salivary gland adenoid cystic carcinoma | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 130 trials | ||||||
| Phase 1 | NCT06161558 | Jul 2025 | neoplasm | National Cancer Institute (NCI) | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT06969001 | May → Sep 2025 | wet macular degeneration | SCAI Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05904730 | Jul 2023 → Nov 2024 | HER2 positive breast carcinoma, Her2-receptor negative breast cancer, hereditary breast ovarian cancer syndrome, ovarian cancer | Lynkcell Europe | Completed | No outcome recorded |
| Phase 1 | NCT04873895 | Jan 2022 → Apr 2024 | colorectal cancer | Abramson Cancer Center at Penn Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05070221 | Oct 2021 → Oct 2023 | melanoma | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 1 | NCT04693468 | Dec 2020 → Dec 2027 expected | high grade malignant neoplasm, metastatic malignant neoplasm | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04458259 | Sep 2020 → Nov 2024 | metastatic malignant neoplasm | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04540705 | Sep 2020 → Jan 2024 | renal cell carcinoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04640545 | May 2020 → Aug 2024 | metastatic melanoma | Nanjing Leads Biolabs Co.,Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03289533 | Sep 2017 → Aug 2019 | hepatocellular carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02782403 | Mar 2017 → Nov 2019 | Philadelphia-positive myelogenous leukemia, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, leukemia, myeloid, accelerated-phase | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02814461 | Nov 2015 → Nov 2018 | hepatocellular carcinoma | Shin Kong Wu Ho-Su Memorial Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02493751 | Oct 2015 → Apr 2018 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02133742 | Sep 2014 → Mar 2017 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02164838 | Sep 2014 → Oct 2017 | refractory malignant neoplasm | Children's Oncology Group | Completed | No outcome recorded |
| Phase 1 | NCT01999972 | Feb 2014 → Feb 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01540526 | Mar 2012 → Sep 2014 | castration-resistant prostate carcinoma | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 1 | NCT01441388 | Dec 2011 → Nov 2013 | glioblastoma, hepatocellular carcinoma, renal cell carcinoma | Pfizer | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT01529138 | Oct 2011 → Mar 2014 | cancer | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT01334073 | Mar 2011 → May 2013 | renal cell carcinoma | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 1 | NCT00919204 | Aug 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00918632 | Jun → Jul 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00842244 | Apr → Dec 2009 | gastric cancer | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00859118 | Feb 2009 → May 2013 | neoplasm | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 1 | NCT00726752 | Jul 2008 → Apr 2010 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00692341 | May → Oct 2008 | liver disorder | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00447005 | Feb 2007 → Aug 2009 | carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00454649 | Dec 2005 → Aug 2009 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00949624 | Dec 2005 → Jun 2008 | cancer | Arog Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01469052 | Nov 2002 → Jul 2004 | neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 1/214 trials · 3 missed | ||||||
| Phase 1/2 | NCT07227415 | Feb 2026 → Nov 2027 expected | clear cell renal carcinoma | Pfizer | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06485908 | Oct 2024 → Apr 2026 overdue | ependymoma, medulloblastoma | Assistance Publique Hopitaux De Marseille | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05808608 | Nov 2023 → Apr 2026 overdue | sarcomatoid renal cell carcinoma | Hao Zeng | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03481842 | Oct 2021 | endometriosis of intestine, ovarian endometriosis | BioGene Pharmaceutical Ltd. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT04585815 | Nov 2020 → May 2023 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04337970 | Apr 2020 → May 2025 | renal cell carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT03386929 | Nov 2017 → Dec 2022 | non-small cell lung carcinoma | Worldwide Innovative Network Association | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03172754 | Jun 2017 → Nov 2026 expected | renal cell carcinoma | Fox Chase Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02667886 | Apr 2016 → Apr 2022 | clear cell renal carcinoma | X4 Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT02535533 | Jan 2016 → Aug 2023 | clear cell renal carcinoma | Mohammed Milhem | Completed | No outcome recorded |
| Phase 1/2 | NCT01211275 | May 2009 → Nov 2012 | malignant pleural mesothelioma | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT00768755 | Jan 2009 → Mar 2011 | non-small cell lung carcinoma | Pfizer | Completed | Missed primary |
| Phase 1/2 | NCT00460603 | Jan 2006 → Apr 2012 | colorectal neoplasm | Pfizer | Completed | Missed primary |
| Phase 1/2 | NCT00076024 | Feb 2004 → Jan 2007 | breast neoplasm | Pfizer | Completed | Missed primary |
| Phase 2108 trials · 5 met primary · 6 missed | ||||||
| Phase 2 | NCT07607561 | Nov 2026 → Aug 2027 expected | wet macular degeneration | SCAI Therapeutics | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07802418 | Oct 2026 → Jun 2031 expected | malignant pancreatic neoplasm | Herlev Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07816770 | Sep 2026 → Dec 2027 expected | kidney medullary carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07469683 | Mar 2026 → Oct 2029 expected | clear cell renal carcinoma | Yonsei University | Recruiting | No outcome recorded |
| Phase 2 | NCT07277972 | Feb 2026 → Nov 2029 expected | clear cell renal carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07123090 | Nov 2025 → Oct 2026 expected | clear cell renal carcinoma | Stephanie Berg | Recruiting | No outcome recorded |
| Phase 2 | NCT07159191 | Sep 2025 → Feb 2027 expected | renal cell carcinoma | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07172386 | Jul 2025 → Jul 2026 overdue | renal cell carcinoma | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06962787 | Jul 2025 → May 2027 expected | kidney cancer | Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06860386 | Feb 2025 → Sep 2026 | clear cell renal carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Suspended | No outcome recorded Stop: Business |
| Phase 2 | NCT05176288 | May 2024 → Aug 2026 | clear cell renal carcinoma | Bradley A. McGregor, MD | Withdrawn | No outcome recorded |
| Phase 2 | NCT06279403 | Mar 2024 → Mar 2026 overdue | clear cell renal carcinoma | RenJi Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06211114 | Feb 2024 → Feb 2026 overdue | collecting duct carcinoma | Peking University Cancer Hospital & Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05969496 | Dec 2023 → Nov 2026 expected | renal cell carcinoma | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 2 | NCT05256472 | Jul 2023 → Dec 2025 | renal cell carcinoma | Akeso | Completed | No outcome recorded |
| Phase 2 | NCT05817903 | Apr 2023 → Apr 2026 overdue | renal cell carcinoma | Consorzio Oncotech | Recruiting | No outcome recorded |
| Phase 2 | NCT05768464 | Feb 2023 → Dec 2026 expected | renal cell carcinoma | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | No outcome recorded |
| Phase 2 | NCT05327686 | Feb 2023 → Jun 2028 expected | renal cell adenocarcinoma | NRG Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT05249569 | Nov → Dec 2022 | hepatocellular carcinoma | University of Texas Southwestern Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT05420220 | Jul 2022 → Dec 2024 | non-small cell lung carcinoma | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT05096390 | Jun 2022 → Oct 2024 | papillary renal cell carcinoma | Centre Leon Berard | Unknown | No outcome recorded |
| Phase 2 | NCT05263609 | Jun 2022 → Jun 2026 | renal cell carcinoma | University of Oklahoma | Withdrawn | No outcome recorded |
| Phase 2 | NCT05384496 | May 2022 → May 2027 expected | mucosal melanoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05097599 | Apr 2022 → Jun 2024 | cancer | Strata Oncology | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05172440 | Dec 2021 → Nov 2023 | — | Hongqian Guo | Unknown | No outcome recorded |
| Phase 2 | NCT04995016 | Aug 2021 → Aug 2022 | clear cell renal carcinoma | Tianjin Medical University Second Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04996823 | Aug 2021 → Aug 2026 overdue | melanoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04958473 | Aug 2021 → Aug 2022 | clear cell renal carcinoma | Tianjin Medical University Second Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04387500 | Jul 2021 → Mar 2025 | inborn disorder of energy metabolism, renal cell carcinoma | West China Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04562441 | May 2021 → Oct 2024 | nasopharyngeal carcinoma | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT04370509 | Feb 2021 → Feb 2025 | clear cell renal carcinoma | University of California, San Francisco | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04197219 | Feb 2021 → Jan 2025 | endometrial cancer | Case Comprehensive Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT04493203 | Dec 2020 → Apr 2024 | melanoma | Yana Najjar | Completed | No outcome recorded |
| Phase 2 | NCT04698213 | Oct 2020 → Sep 2023 | renal cell carcinoma | Consorzio Oncotech | Unknown | No outcome recorded |
| Phase 2 | NCT04459663 | Aug 2020 → Sep 2023 | non-small cell lung carcinoma | Li Zhang, MD | Unknown | No outcome recorded |
| Phase 2 | NCT04341181 | Aug 2020 → Apr 2029 expected | cancer | Ulrik Lassen | Recruiting | No outcome recorded |
| Phase 2 | NCT04385654 | Jun 2020 → Dec 2021 | kidney cancer | West China Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04010071 | May 2020 → Jan 2024 | biliary tract neoplasm, liver cancer | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04118855 | Mar 2020 → Feb 2023 | renal cell adenocarcinoma | RenJi Hospital | Completed | Met primary |
| Phase 2 | NCT04180995 | Aug 2019 → Jul 2022 | mucosal melanoma | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 2 | NCT03990571 | Jul 2019 → Mar 2023 | adenoid cystic carcinoma | M.D. Anderson Cancer Center | Completed | Met primary |
| Phase 2 | NCT04258956 | Apr 2019 → Apr 2021 | gastrointestinal stromal tumor | Maria Sklodowska-Curie National Research Institute of Oncology | Completed | No outcome recorded |
| Phase 2 | NCT03839498 | Jan 2019 → Jan 2027 expected | paraganglioma, pheochromocytoma | Columbia University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03595124 | Jan 2019 → Sep 2024 overdue | renal cell carcinoma associated with Xp11.2 translocations/TFE3 gene fusions | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06889649 | Jan 2019 → Feb 2027 expected | renal cell carcinoma | Peking University First Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT03736330 | Sep 2018 → Oct 2020 | renal cell carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT03472560 | May 2018 → Feb 2023 | non-small cell lung carcinoma, urothelial carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT03341845 | Mar 2018 → Jan 2023 | renal cell carcinoma | The Netherlands Cancer Institute | Unknown | No outcome recorded |
| Phase 2 | NCT03297606 | Mar 2018 → Dec 2026 expected | non-Hodgkin lymphoma, plasma cell myeloma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT03438708 | Mar 2018 → Mar 2026 overdue | clear cell renal carcinoma | University of California, San Diego | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03494816 | Dec 2017 → Mar 2020 | renal cell carcinoma | Scottish Clinical Trials Research Unit | Completed | No outcome recorded |
| Phase 2 | NCT03592199 | Dec 2017 → Dec 2019 | clear cell renal carcinoma | Cancer Institute of the State of São Paulo | Unknown | No outcome recorded |
| Phase 2 | NCT03092856 | Jul 2017 → Dec 2026 expected | clear cell renal carcinoma | University of Southern California | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03291314 | May 2017 → Jan 2019 | glioblastoma | University Hospital Brussels | Completed | No outcome recorded |
| Phase 2 | NCT02788201 | Mar 2017 → Oct 2019 | urinary bladder cancer, urothelial carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT02912572 | Nov 2016 → Nov 2023 overdue | endometrial cancer | Dana-Farber Cancer Institute | Active not recruiting | Met primary |
| Phase 2 | NCT02859012 | Sep 2016 → Dec 2017 | carcinoma | Seoul National University Hospital | Completed | Met primary |
| Phase 2 | NCT02762513 | Aug 2016 → Apr 2020 | head and neck squamous cell carcinoma | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 2 | NCT02636725 | Apr 2016 → May 2018 | alveolar soft part sarcoma | Jonathan Trent, MD, PhD | Completed | No outcome recorded |
| Phase 2 | NCT02560012 | Jan 2016 → Jul 2017 | renal cell carcinoma | The University of Texas Health Science Center, Houston | Terminated | No outcome recorded |
| Phase 2 | NCT02700568 | Jan 2016 → Jun 2018 | clear cell renal carcinoma | Kidney Cancer Research Bureau | Completed | No outcome recorded |
| Phase 2 | NCT02579811 | Dec 2015 → Aug 2019 | renal cell carcinoma | Case Comprehensive Cancer Center | Completed | Missed primary |
| Phase 2 | NCT02638428 | Dec 2015 → Dec 2021 | childhood acute myeloid leukemia | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02489695 | Oct 2015 → Jul 2019 | papillary renal cell carcinoma | Centre Leon Berard | Completed | No outcome recorded |
| Phase 2 | NCT02857712 | Dec 2014 → Oct 2018 | salivary gland cancer | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Completed | No outcome recorded |
| Phase 2 | NCT02261207 | Nov 2014 → Oct 2017 | solitary fibrous tumor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Completed | No outcome recorded |
| Phase 2 | NCT01562197 | Apr 2014 → Aug 2018 | glioblastoma | Bart Neyns | Completed | No outcome recorded |
| Phase 2 | NCT02129647 | Apr 2014 → Feb 2019 | NF2-related schwannomatosis, acoustic neuroma | NYU Langone Health | Completed | No outcome recorded |
| Phase 2 | NCT01967576 | Oct 2013 → Jun 2015 | paraganglioma, pheochromocytoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01798446 | Feb 2013 → Jun 2015 | renal cell carcinoma | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01693822 | Oct 2012 → Mar 2017 | clear cell renal carcinoma | Institute of Cancer Research, United Kingdom | Completed | No outcome recorded |
| Phase 2 | NCT04355156 | Sep 2012 → Feb 2019 | colorectal cancer | Imperial College London | Completed | No outcome recorded |
| Phase 2 | NCT01649180 | Jul 2012 → Jan 2016 | renal cell carcinoma | PrECOG, LLC. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01409200 | Mar 2012 → Feb 2026 | metastatic malignant neoplasm in the lymph nodes, prostate adenocarcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01558661 | Mar 2012 → Aug 2016 | adenoid cystic carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01483638 | Feb 2012 → Sep 2015 | colorectal carcinoma | Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02597322 | Feb 2012 → Nov 2015 | kidney neoplasm | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT01490866 | Jan 2012 → Jul 2015 | colorectal cancer | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01469546 | Jan 2012 → Apr 2015 | head and neck squamous cell carcinoma | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01533948 | Jan 2012 → Jul 2015 | ocular melanoma with extraocular extension, uveal melanoma | Roswell Park Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01321437 | Dec 2011 → Dec 2016 | melanoma | University of California, Irvine | Completed | No outcome recorded |
| Phase 2 | NCT01385059 | Oct 2011 → Oct 2013 | prostate cancer | City of Hope Medical Center | Completed | Missed primary |
| Phase 2 | NCT01435122 | Oct 2011 → Jan 2017 | carcinoid tumor | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT01508117 | Aug 2011 → Oct 2012 | glioblastoma | University of Cincinnati | Terminated | No outcome recorded |
| Phase 2 | NCT01352728 | May 2011 → Jun 2018 | hepatocellular carcinoma | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT01273662 | Apr 2011 → Mar 2016 | hepatocellular carcinoma | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01263769 | Feb 2011 → Feb 2021 | kidney cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01334112 | Jan 2011 → Mar 2018 | hepatocellular carcinoma | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 2 | NCT01210495 | Dec 2010 → Mar 2014 | hepatocellular carcinoma | Pfizer | Completed | Missed primary |
| Phase 2 | NCT01249547 | Dec 2010 → Dec 2016 | nasopharyngeal carcinoma | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT01255137 | Sep 2010 → Dec 2012 | adrenal cortex neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01140737 | Aug 2010 → Jun 2016 | soft tissue sarcoma | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT01174238 | Jul 2010 → Aug 2013 | melanoma | Adil Daud | Completed | No outcome recorded |
| Phase 2 | NCT00835978 | Aug 2009 → Oct 2012 | renal cell carcinoma | Pfizer | Completed | Met primary |
| Phase 2 | NCT00735904 | Dec 2008 → Nov 2011 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00600821 | Apr 2008 → Apr 2011 | adenocarcinoma, non-small cell lung carcinoma | Pfizer | Completed | Missed primary |
| Phase 2 | NCT00615056 | Mar 2008 → Mar 2011 | colorectal cancer | Pfizer | Completed | Missed primary |
| Phase 2 | NCT00569946 | Dec 2007 → Feb 2010 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00386555 | May 2007 → ? | non-small cell lung carcinoma | Arog Pharmaceuticals, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00389441 | Dec 2006 → Sep 2012 | thyroid tumor | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00282048 | Mar 2006 → Feb 2009 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00219557 | Jul 2005 → Mar 2008 | malignant pancreatic neoplasm | Pfizer | Completed | Missed primary |
| Phase 2 | NCT00094094 | Feb 2005 → Jul 2007 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00094107 | Dec 2004 → Apr 2008 | melanoma, skin neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00094055 | Sep 2004 → Jan 2009 | thyroid tumor | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00076011 | Oct 2003 → Feb 2007 | kidney neoplasm | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00071006 | Sep 2003 → Jul 2004 | acute myeloid leukemia, myelodysplastic syndrome | Pfizer | Completed | No outcome recorded |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT06020352 | Aug 2023 → Jul 2025 | non-small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Unknown | No outcome recorded |
| Phase 2/3 | NCT01744249 | Nov 2011 → Dec 2023 | neuroendocrine neoplasm | Spanish Group for Research in Neuroendocrine Tumors | Completed | Missed primary |
| Phase 314 trials · 3 met primary · 3 missed | ||||||
| Phase 3 | NCT07516132 | Apr 2026 → Aug 2030 expected | age-related macular degeneration | Ocular Therapeutix, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07235085 | Nov 2025 → Mar 2027 expected | diabetic retinopathy | Ocular Therapeutix, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06495918 | Nov 2024 → Jan 2027 expected | wet macular degeneration | Ocular Therapeutix, Inc. | Active not 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 | NCT06223958 | Jan 2024 → Apr 2026 overdue | wet macular degeneration | Ocular Therapeutix, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05738694 | Apr 2023 → Dec 2027 expected | renal cell carcinoma | ZHOU FANGJIAN | Recruiting | No outcome recorded |
| Phase 3 | NCT05059522 | Sep 2021 → Dec 2026 expected | non-small cell lung carcinoma, ovarian cancer, urothelial carcinoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04394975 | Aug 2020 → Apr 2024 | renal cell adenocarcinoma | Shanghai Junshi Bioscience Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT02853331 | Sep 2016 → Oct 2018 | renal cell carcinoma | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02684006 | Mar 2016 → Aug 2023 | renal cell carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01599754 | Apr 2012 → Oct 2017 | clear cell renal carcinoma | SFJ Pharma Ltd. II | Terminated | Missed primary |
| Phase 3 | NCT00920816 | Aug 2009 → Jul 2012 | kidney neoplasm | Pfizer | Completed | Missed primary |
| Phase 3 | NCT00678392 | Sep 2008 → Aug 2010 | renal carcinoma | Pfizer | Completed | Met primary |
| Phase 3 | NCT00471146 | Jul 2007 → Jan 2009 | pancreatic ductal adenocarcinoma | Pfizer | Completed | Missed primary |
| Phase not applicable5 trials | ||||||
| — | NCT05816642 | Aug 2022 → Dec 2023 | renal cell carcinoma | RenJi Hospital | Unknown | No outcome recorded |
| — | NCT03826589 | Jun 2019 → Mar 2024 | cervical cancer | The University of Hong Kong | Completed | No outcome recorded |
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| — | NCT01486251 | Sep 2011 → Apr 2013 | colorectal carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Completed | No outcome recorded |
| — | NCT00828919 | Mar 2003 → Aug 2023 | cancer | Pfizer | Completed | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT01473043 | Mar 2012 → Mar 2014 | renal cell carcinoma | Pfizer | No longer available | No outcome recorded |
| — | NCT05941637 | — | clear cell renal carcinoma | Lynkcell Europe | No longer available | No outcome recorded |
| Comparator or background therapy23 trials | ||||||
| Phase 1 | NCT06424626 Background | May 2024 → Dec 2027 expected | metastatic melanoma, mucosal melanoma | Peking University Cancer Hospital & Institute | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT05695417 Comparator | Jan 2023 → Jan 2024 | severe nonproliferative diabetic retinopathy | Ocular Therapeutix, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT05017012 Background | Sep 2021 → May 2026 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT04522323 Background | Aug 2020 → Sep 2025 overdue | renal cell carcinoma | MedImmune LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03275558 Comparator | Jul 2018 | gliosarcoma | Center Trials & Treatment | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT07630363 Background | May 2026 → Mar 2028 expected | clear cell renal carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05949632 Background | Apr 2024 → Jun 2025 | cancer | Incyte Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT05363631 Background | Sep 2022 → Dec 2026 expected | clear cell renal carcinoma | Mohammed Milhem | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01806064 Comparator | Mar 2013 → Dec 2018 | renal cell carcinoma | Tracon Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT06690697 Comparator | Jun 2024 → Jun 2026 overdue | clear cell renal carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT05805501 Background | Apr 2023 → Oct 2026 expected | renal cell carcinoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03941795 Comparator | Nov 2019 → Jun 2022 | mucosal melanoma | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 2 | NCT02639182 Comparator | May 2016 → Oct 2020 | renal cell carcinoma | Astellas Pharma Global Development, Inc. | Completed | Missed primary |
| Phase 2 | NCT02187302 Comparator | Jul 2014 → Jul 2016 | renal cell carcinoma | NewLink Genetics Corporation | Completed | Missed primary |
| Phase 2 | NCT01727336 Background | Dec 2012 → Jun 2017 | renal cell carcinoma | Acceleron Pharma, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01441414 Comparator | Nov 2011 → Mar 2014 | renal cell carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 2/3 | NCT05522231 Comparator | Oct 2022 → Jan 2025 overdue | renal cell carcinoma | Hutchmed | Active not recruiting | Met primary |
| Phase 3 | NCT07383441 Background | Jun 2026 → Jan 2033 expected | clear cell renal carcinoma | SWOG Cancer Research Network | 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 | NCT04510597 Comparator | Mar 2021 → Jul 2033 expected | clear cell renal carcinoma | SWOG Cancer Research Network | 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 |
| — | NCT07500831 Background | Apr 2026 → Apr 2028 expected | renal cell carcinoma | Qilu Hospital of Shandong University | Not yet recruiting | No outcome recorded |
| — | NCT02354612 Background | — | cancer | Tracon Pharmaceuticals Inc. | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 44
| Date | Issuer | Release |
|---|---|---|
| 2026-04-13 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ Announces Additional Positive Week 52 Data from Landmark SOL-1 Phase 3 Trial of AXPAXLI™ in Wet AMD ocutx.com ↗
The median time to ≥30 uM Central Subfield Thickness (CSFT) increase from Week 8 was 39 weeks in the AXPAXLI group and 16 weeks in the aflibercept (2 mg) group, a 23-week difference. |
| 2026-02-17 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ Reports Positive Results from Landmark SOL-1 Phase 3 Superiority Trial in Wet AMD ocutx.com ↗
The fact that AXPAXLI delivered these consistent, durable, and superior outcomes in this trial provides further evidence of axitinib’s potency and pan-VEGF suppression paired with the robustness and safety of our proprietary hydrogel platform. |
| 2025-10-13 | Hutchison Medipharma Limited | Results HUTCHMED Highlights FRUSICA-2 Registration Trial Data to be Presented at the 2025 ESMO Congress hutch-med.com ↗
The median PFS as assessed by blinded independent central review (BICR) was 22.2 months with fruquintinib plus sintilimab, compared to 6.9 months with axitinib/everolimus (stratified hazard ratio [HR] 0.373; stratified log-rank p<0.0001). |
| 2025-08-12 | Ocular Therapeutix, Inc. | Regulatory Ocular Therapeutix™ Receives FDA Agreement Under Special Protocol Assessment (SPA) for Registrational Trial of AXPAXLI™ in NPDR ocutx.com ↗
Securing a Special Protocol Assessment agreement from the FDA for our planned NPDR trial represents a major milestone as we look to broaden the impact of AXPAXLI beyond wet AMD and into diabetic eye disease. |
| 2025-03-03 | Ocular Therapeutix, Inc. | Regulatory Ocular Therapeutix™ Reports Fourth Quarter and Full Year 2024 Results and Business Highlights ocutx.com ↗
FDA approves Amendment to SOL-1 Special Protocol Agreement (SPA) to include AXPAXLI re-dosing at Weeks 52 and 76 |
| 2024-10-09 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ to Present at October Ophthalmology Meetings ocutx.com ↗
Fifty-Two-Week Sustained Efficacy and Treatment Burden Reduction with OTX-TKI in the U.S. Phase 1 Trial for nAMD |
| 2024-08-07 | Ocular Therapeutix, Inc. | Regulatory Ocular Therapeutix™ Reports Second Quarter 2024 Results ocutx.com ↗ |
| 2024-08-07 | Ocular Therapeutix, Inc. | Regulatory Ocular Therapeutix™ Announces FDA Feedback That SOL-R Trial is Appropriate as a Registrational Study in Wet AMD ocutx.com ↗
In a Type C written response, the FDA agreed that the SOL-R repeat dosing wet AMD study is appropriate as an adequate and well-controlled study in support of a potential New Drug Application (NDA) and product label. |
| 2024-06-13 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ Highlights Exceptional AXPAXLI™ SOL-1 Enrollment and Plans for Repeat Dosing Study (SOL-R) in wet AMD at Investor Day, Along with Positive 48-week Data from HELIOS NPDR Study ocutx.com ↗
48-week HELIOS NPDR results show 23.1% of patients in AXPAXLI arm experienced ≥2-step DRSS improvement with no patients experiencing worsening of DRSS or vision threatening complications |
| 2024-04-18 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ Announces Positive Topline Phase 1 Data for AXPAXLI™ in Diabetic Retinopathy ocutx.com ↗
today announced positive topline results from the Phase 1 HELIOS study evaluating AXPAXLI versus a sham control in patients with moderately severe to severe non-proliferative diabetic retinopathy (‘NPDR’, NCT05695417) without diabetic macular edema (DME). |
| 2024-01-25 | Ocular Therapeutix, Inc. | Regulatory Ocular Therapeutix™ Announces FDA Agreement to Amend Special Protocol Assessment (SPA) for Pivotal Clinical Trial of AXPAXLI™ in Wet AMD ocutx.com ↗
The SPA Agreement Modification enables the trial to include treatment-naïve wet AMD subjects with visual acuity of approximately 20/80 or better at the initial screening visit. |
| 2023-11-01 | Ocular Therapeutix, Inc. | Regulatory Ocular Therapeutix™ Receives FDA Agreement Under Special Protocol Assessment (SPA) for its First Pivotal Clinical Trial of OTX-TKI in Wet AMD ocutx.com ↗
received written agreement regarding the overall design from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the Company’s ongoing pivotal Phase 3 clinical trial for AXPAXLI (axitinib intravitreal implant) |
| 2023-06-10 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ Announces 12-Month Topline Data from Ongoing U.S.-Based Phase 1 Clinical Trial Evaluating OTX-TKI for Treatment of Wet AMD ocutx.com ↗
OTX-TKI maintained vision and CSFT comparable to aflibercept every eight weeks, with 89% reduction in treatment burden over a 12-month period |
| 2023-03-06 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ Provides Fourth Quarter and Year-End 2022 Results and Corporate Update ocutx.com ↗
Overall, a 92% reduction in treatment burden was observed in OTX-TKI treated subjects for up to 10 months. |
| 2023-02-11 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ Announces Interim 10-month Data from the Ongoing U.S. Phase 1 Clinical Trial Evaluating OTX-TKI for the Treatment of Wet AMD ocutx.com ↗
All OTX-TKI treated subjects who were rescue-free at the Month 7 interim analysis remained rescue-free, extending the 73% rescue-free rate up to Month 10 |
| 2022-09-27 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ Announces Interim 7-month Data from U.S. Phase 1 Clinical Trial of OTX-TKI for the Treatment of Wet AMD ocutx.com ↗
Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced interim 7-month data from its U.S. Phase 1 clinical trial evaluating OTX-TKI, the Company’s axitinib intravitreal hydrogel implant being developed for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases. |
| 2021-10-28 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ to Present Data at the American Academy of Ophthalmology (AAO) 2021 Virtual Annual Meeting ocutx.com ↗
To date, OTX-TKI has been generally well tolerated and showed preliminary biological signals of durability and meaningful decrease in retinal thickness. |
| 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 ↗
Additionally, a matching-adjusted indirect comparison analysis is being presented, demonstrating superior, statistically significant differences in health-related quality of life across all outcomes analysed in favour of Cabometyx and nivolumab versus the combination of axitinib and pembrolizumab (Abstract 668P). |
| 2021-05-05 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ Reports First Quarter 2021 Financial Results and Business Update ocutx.com ↗
Updated interim analyses of Phase 1 data for both OTX-TKI for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases and OTX-TIC for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension were presented. |
| 2020-12-01 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA tentative approval for Axitinib Tablets,1 mg and 5 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals Inc., USA (Glenmark) has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Axitinib Tablets, 1 mg and 5 mg, the generic version of Inlyta®1 Tablets, 1 mg and 5 mg, of PF Prism C.V. |
| 2020-11-11 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ To Present Data at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting ocutx.com ↗
Evidence of biological activity is demonstrated across the three dose groups as measured by a decrease in subretinal and/or intraretinal fluid. |
| 2020-05-08 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ Reports First Quarter 2020 Financial Results and Business Update ocutx.com ↗
Data from both cohorts continue to demonstrate that OTX-TKI has been generally well tolerated and is observed to have a favorable safety profile, with no ocular serious adverse events to date. |
| 2019-12-20 | Merck Sharp & Dohme LLC | Regulatory Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or Distant Metastatic Head and Neck Cancer merck.com ↗
Today’s approval of three new first-line KEYTRUDA regimens represents a significant milestone for patients diagnosed with these aggressive forms of cancer and will provide patients in Japan with important alternatives to standard therapies. |
| 2019-10-28 | Pfizer | Regulatory European Commission Approves BAVENCIO® (avelumab) Plus Axitinib Combination for First-Line Treatment of Patients With Advanced Renal Cell Carcinoma pfizer.com ↗
today announced that the European Commission (EC) has approved BAVENCIO® (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). |
| 2019-09-27 | Pfizer | Results New Data for BAVENCIO® (avelumab) for Advanced Cancers to Be Presented at ESMO 2019 pfizer.com ↗
Analyses from the Phase III JAVELIN Renal 101 study support efficacy of BAVENCIO plus axitinib across multiple subgroups of patients with advanced renal cell carcinoma (RCC) |
| 2019-09-20 | Pfizer | Regulatory CHMP Adopts Positive Opinion for BAVENCIO® (avelumab) Plus Axitinib for First-Line Treatment of Patients with Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2019-09-04 | Merck Sharp & Dohme LLC | Regulatory European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma (RCC) merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). |
| 2019-07-29 | Merck Sharp & Dohme LLC | Regulatory European Medicines Agency Adopts Positive Opinion for Merck’s KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). |
| 2019-05-14 | Pfizer | Regulatory FDA Approves BAVENCIO® (avelumab) Plus INLYTA® (axitinib) Combination for Patients with Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2019-04-22 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Inlyta® (axitinib) as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma (RCC) merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). |
| 2019-03-08 | Pfizer | Regulatory European Medicines Agency Validates Application for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) for the Treatment of Advanced Renal Cell Carcinoma pfizer.com ↗
Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the European Medicines Agency (EMA) has validated for review the Type II variation application for BAVENCIO ® (avelumab) in combination with INLYTA® (axitinib)* for the treatment of patients with advanced renal cell carcinoma (RCC). |
| 2019-02-16 | Merck KGaA, Darmstadt, Germany | Results Pivotal Phase III Data for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) in Advanced Renal Cell Carcinoma Published in the New England Journal of Medicine prnewswire.com ↗
Further, the objective response rate (ORR) was doubled with BAVENCIO+INLYTA versus SUTENT in this population (51.4% [95% CI: 46.6-56.1] vs. 25.7% [95% CI: 21.7-30.0]). |
| 2019-02-16 | Pfizer | Results Pivotal Phase III Data for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) in Advanced Renal Cell Carcinoma Published in The New England Journal of Medicine pfizer.com ↗
Further, the objective response rate (ORR) was doubled with BAVENCIO+INLYTA versus SUTENT in this population (51.4% [95% CI: 46.6-56.1] vs. 25.7% [95% CI: 21.7-30.0]). |
| 2019-02-16 | Merck Sharp & Dohme LLC | Results KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) Reduced Risk of Death by Nearly Half Compared to Sunitinib as First-Line Treatment for Advanced Renal Cell Carcinoma (RCC) merck.com ↗
This is the first combination regimen to significantly improve overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to sunitinib. |
| 2019-02-15 | Merck Sharp & Dohme LLC | Regulatory FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). |
| 2019-02-11 | Pfizer | Regulatory FDA Accepts sBLA and Grants Priority Review for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) for the Treatment of Advanced Renal Cell Carcinoma pfizer.com ↗
the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for BAVENCIO ® (avelumab) in combination with INLYTA ® (axitinib)* for patients with advanced renal cell carcinoma (RCC). |
| 2019-02-11 | Merck Sharp & Dohme LLC | Results Merck Highlights Breadth of Immuno-Oncology Research Program in Genitourinary Cancers at ASCO GU merck.com ↗
Results across OS, PFS and ORR were consistent across all IMDC risk groups and regardless of PD-L1 expression. |
| 2018-10-25 | Merck Sharp & Dohme LLC | Results Merck Announces Third-Quarter 2018 Financial Results merck.com ↗
Results from KEYNOTE-426 Studying KEYTRUDA in Combination with Axitinib as First-line Treatment for Advanced or Metastatic Renal Cell Carcinoma Met Primary Endpoints of Overall Survival and Progression-Free Survival |
| 2018-10-18 | Merck Sharp & Dohme LLC | Results Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pfizer’s Inlyta® (axitinib) Significantly Improved Overall Survival (OS) and Progression-free Survival (PFS) as First-Line Therapy for Advanced or Metastatic Renal Cell Carcinoma merck.com ↗
Based on the first interim analysis by the independent Data Monitoring Committee (DMC), the KEYTRUDA plus Inlyta combination resulted in statistically significant and clinically meaningful improvements in OS and PFS, compared to sunitinib monotherapy. |
| 2018-09-11 | Pfizer | Results BAVENCIO® (avelumab) Plus INLYTA® (axitinib) Significantly Improved Progression-Free Survival in Previously Untreated Patients with Advanced Renal Cell Carcinoma in Phase III Study pfizer.com ↗ |
| 2018-04-10 | Pfizer | Results Pfizer Provides Update on Phase 3 Trial of Axitinib as Adjuvant Treatment for Patients at High Risk of Renal Cell Carcinoma Recurrence After Surgery pfizer.com ↗
The recommendation was based on the study failing to demonstrate a clear improvement in the primary endpoint of extending disease-free survival (DFS) for patients treated with INLYTA compared with patients treated with placebo. |
| 2017-12-21 | Merck KGaA, Darmstadt, Germany | Regulatory FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA® in Advanced Renal Cell Carcinoma prnewswire.com ↗ |
| 2017-12-21 | Pfizer | Regulatory FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA® in Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2016-10-09 | Pfizer | Results Pfizer Presents Promising New Immunotherapy Combination Data With INLYTA® (axitinib) In Advanced Renal Cell Carcinoma (RCC) pfizer.com ↗
The results presented today indicate that there is a potential additive or synergistic effect between INLYTA and a checkpoint inhibitor in RCC. |
All press releases naming this drug 55 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 200 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Axitinib | “Drugs may include all or a subset of the following which each may be tested as single agents or in any number of combinations including, but not limited to: Lenvatinib,...” NCT05553782 ↗192“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 ↗ “Axitinib, a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors, has shown activity in advanced thyroid cancer in a Phase II study.” PMID 25315258 ↗ Oct 2014 “Axitinib (AG-013736) is a potent and selective oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, which have an important role in pancreatic cancer.” PMID 18514303 ↗ May 2008 “Within the SOC arm, patients received single-agent bevacizumab (19), axitinib (18), everolimus (7), pazopanib (4), sorafenib (4), sunitinib (2), or temsirolimus (2).” PMID 28950297 ↗ Nov 2017 “Axitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib” NCT07802418 ↗ “BACKGROUND: Axitinib (AG-013736) is an oral, selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, 2 and 3.” PMID 21889330 ↗ Aug 2011 “To assess the single-dose and multiple-dose pharmacokinetics (PK), safety and tolerability of SCAI-005 eyedrops(axitinib) in healthy volunteers” NCT06969001 ↗ “AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID-” NCT00600821 ↗ “Axitinib (AG-013736) is an oral, potent, and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3.” PMID 17959415 ↗ Oct 2007 “Axitinib continuous oral dosing (10 mg once a day, 10 mg twice a day, 20 mg twice a day or 30 mg twice day) in the fed state” NCT01469052 ↗ |
| Known as | A-013736 | “A-013736 (Axitinib) is a selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, and is therefore classed as an angiogenesis inhibitor with VEGF...” NCT04355156 ↗ |
| Known as | AG-013736 | “Axitinib (AG-013736; Pfizer) is a multi-targeted small-molecule inhibitor of the receptor tyrosine kinases involved in tumor proliferation and angiogenesis, including VEGFR-1,...” NCT02859012 ↗44“A PHASE 1B, OPEN LABEL, DOSE FINDING STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AXITINIB (AG-013736) IN COMBINATION WITH PEMBROLIZUMAB (MK-3475) IN...” NCT02133742 ↗ “Axitinib (AG-013736) is a potent and selective oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, which have an important role in pancreatic cancer.” PMID 18514303 ↗ May 2008 “Axitinib (AG-013736, Pfizer Inc.), a receptor-tyrosine kinase inhibitor that is selective for VEGFR1, 2, and 3, is an important new agent for use in metastatic RCC.” NCT01649180 ↗ “BACKGROUND: Axitinib (AG-013736) is an oral, selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, 2 and 3.” PMID 21889330 ↗ Aug 2011 “Axitinib (AG-013736) is an oral, potent and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, and 3.” NCT01967576 ↗ “Axitinib (AG-013736) is an oral, potent and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, and 3.” NCT01255137 ↗ “Axitinib (AG-013736) is an oral, potent and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, and 3.” NCT03839498 ↗ “Effect of axitinib (AG-013736) on fatigue, thyroid-stimulating hormone, and biomarkers: a phase I study in Japanese patients.” PMID 20180805 ↗ Dec 2009 “Axitinib (AG-013736) is an oral, potent, and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3.” PMID 17959415 ↗ Oct 2007 “Axitinib (AG-013736) tablet administered orally at a dose of 5 milligrams (mg) twice daily (BID) in cycles of 4 weeks.” NCT00094094 ↗ |
| Known as | Inlyta | “This arm of the Strata PATH trial will assess the clinical benefit of Inlyta® (axitinib) in patients with advanced solid tumors and are Angiogensis Inhibitor Treatment Response...” NCT05097599 ↗5“Axitinib (Inlyta, Pfizer Inc.) is a novel oral angiogenesis inhibitor that selectively targets vascular endothelial growth factor (VEGFR) 1, 2 and 3.” NCT04010071 ↗ “Axitinib (Inlyta®) PO, in the morning and in the evening every day” NCT06485908 ↗ “TORIPALIMAB INJECTION(JS001 ) Axitinib tablet (Inlyta®)” NCT04180995 ↗ “Axitinib Oral Tablet [Inlyta]” NCT05096390 ↗ “Axitinib 1 MG [Inlyta]” NCT03941795 ↗ |
| Known as | Inritar | “1. Axitinib (Inritar)” NCT07630363 ↗ |
| Known as | OTX-TKI | “Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration” NCT06495918 ↗3“Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration” NCT06223958 ↗ “Intravitreal OTXTKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy” NCT07235085 ↗ “OTX-TKI (Axitinib Implant)” NCT05695417 ↗ |
| Action | Inhibit | “selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3” PMID 17959415 ↗ Oct 2007 |
| Modality | Small molecule | “axitinib, a small molecule tyrosine kinase inhibitor (TKI)” NCT02667886 ↗ |
| Route | Oral | “received axitinib orally” PMID 17959415 ↗ Oct 2007 |
| Target | KDR | “Tyrosine Kinase Inhibitor Of VEGFR-2” NCT01469052 ↗ |