Drugs / Eribulin
Eribulin
also known as
eribulin mesylate · E7389 · eribulin mesilate · Halaven · B-1939 · E-7389 FREE BASE · E7389-LF · ER-086526 · +12 more
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed female breast nipple and areola cancer 4 milestones | |||||
| Filed | China (NMPA) | Halaven | female breast nipple and areola cancer | 2017-11-29 | “the China Food and Drug Administration (CFDA) has accepted for review the resubmitted New Drug Application (NDA) for Eisai's anticancer agent eribulin mesylate (“eribulin”,...” eisai.com ↗ |
| Filed | China (NMPA) | Halaven | female breast nipple and areola cancer | 2016-08-05 | “the China Food and Drug Administration (CFDA) has accepted for review a New Drug Application (NDA) submitted for Eisai's in-house developed anticancer agent eribulin mesylate” eisai.com ↗ “In July 2016, Eisai submitted an NDA for eribulin for use in the treatment of locally advanced or metastatic breast cancer in China.” eisai.com ↗ |
| Filed | Other | Halaven | female breast nipple and areola cancer | 2009-07-27 | “has filed a New Drug Submission (NDS) with the Canadian regulatory authorities for the anticancer agent Halaven®” eisai.com ↗ “has submitted to the health authorities (Swissmedic) marketing authorisation applications for eribulin mesylate” eisai.com ↗ |
| Filed | EU (EMA) | Halaven | female breast nipple and areola cancer | — | “has filed an application to the European Medicines Agency (EMA) for Halaven as a therapy in the treatment of breast cancer” eisai.com ↗ |
| Filed metastatic squamous cell carcinoma 1 milestone | |||||
| Filed | EU (EMA) | Halaven | metastatic squamous cell carcinoma | 2013-05-07 | “Eisai Europe Ltd., has filed an application with the European Medicines Agency (EMA) for anticancer agent Halaven® (eribulin mesylate, “eribulin”), requesting an indication expansion” eisai.com ↗ |
| Filed soft tissue sarcoma 3 milestones | |||||
| Filed | EU (EMA) | Halaven | soft tissue sarcoma | 2015-07-30 | “Having simultaneously submitted marketing authorization applications to the regulatory authorities in Japan, the United States and the European Union (EU) in March 2010” eisai.com ↗ “an application seeking approval for a new indication of soft tissue sarcoma for eribulin was submitted in Japan, the United States and Europe.” eisai.com ↗ “Applications seeking approval of Halaven for use in the treatment of soft tissue sarcoma have been submitted in Europe and Japan.” eisai.com ↗ “submitted applications to regulatory authorities in Japan, the United States and Europe (MHLW, FDA and EMA respectively)” eisai.com ↗ |
| Filed | Japan (PMDA) | Halaven | soft tissue sarcoma | 2015-07-30 | “Having simultaneously submitted marketing authorization applications to the regulatory authorities in Japan, the United States and the European Union (EU) in March 2010” eisai.com ↗ “an application seeking approval for a new indication of soft tissue sarcoma for eribulin was submitted in Japan, the United States and Europe.” eisai.com ↗ “Applications seeking approval of Halaven for use in the treatment of soft tissue sarcoma have been submitted in Europe and Japan.” eisai.com ↗ “submitted applications to regulatory authorities in Japan, the United States and Europe (MHLW, FDA and EMA respectively)” eisai.com ↗ |
| Filed | US (FDA) | Halaven | soft tissue sarcoma | 2015-07-30 | “Having simultaneously submitted marketing authorization applications to the regulatory authorities in Japan, the United States and the European Union (EU) in March 2010” eisai.com ↗ “an application seeking approval for a new indication of soft tissue sarcoma for eribulin was submitted in Japan, the United States and Europe.” eisai.com ↗ “submitted applications to regulatory authorities in Japan, the United States and Europe (MHLW, FDA and EMA respectively)” eisai.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | HALAVEN | — | 2016-01-28 – 2022-09-13 | fda.gov ↗ |
| Approved | EU (EMA) | Halaven | — | 2011-03-17 | europa.eu ↗ |
| Approved | US (FDA) | HALAVEN | — | 2010-11-15 | fda.gov ↗ |
Trials 173 · started per year
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US approved 2010
EU approved 2011
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05238831 | Jan 2023 → May 2026 | female breast carcinoma, ovarian carcinoma, pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 0 | NCT02338037 | May 2015 → Aug 2017 | metastatic malignant neoplasm in the brain, primary brain neoplasm | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 134 trials · 1 met primary | ||||||
| Phase 1 | NCT06957431 | Oct 2025 → May 2031 expected | leiomyosarcoma, liposarcoma | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT06590558 | Aug 2025 → May 2027 | female breast carcinoma, hormone receptor-positive breast cancer, invasive breast carcinoma, triple-negative breast carcinoma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 1 | NCT06006273 | Aug 2023 → Dec 2026 expected | refractory malignant neoplasm | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05774886 | May → Sep 2023 | female breast carcinoma, triple-negative breast carcinoma | Dana-Farber Cancer Institute | Withdrawn | No outcome recorded |
| Phase 1 | NCT04013217 | Jul 2019 → Mar 2022 | cancer | Health Hope Pharma | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03502681 | Jun 2018 → Oct 2019 | urothelial carcinoma | Monika Joshi, MD | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03579472 | May 2018 → Sep 2022 | female breast carcinoma, triple-negative breast carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT03430518 | May 2018 → Feb 2020 | Her2-receptor negative breast cancer, ovarian cancer | Amy Tiersten | Completed | No outcome recorded |
| Phase 1 | NCT03361436 | Mar 2018 → Feb 2023 overdue | liposarcoma, retroperitoneal cancer, scrotum cancer, spermatic cord cancer | OHSU Knight Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03207672 | Aug 2017 → Jul 2018 overdue | cancer | Eisai Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03056599 | Dec 2016 → Jul 2021 | soft tissue sarcoma | Presage Biosciences | Completed | Met primary |
| Phase 1 | NCT02824575 | Jul 2016 → Dec 2021 | Her2-receptor negative breast cancer, breast adenocarcinoma | Montefiore Medical Center | Terminated | No outcome recorded |
| Phase 1 | NCT02616848 | Nov 2015 | triple-negative breast carcinoma | Istituti Ospitalieri di Cremona | Unknown | No outcome recorded |
| Phase 1 | NCT02596503 | Oct 2015 → Apr 2019 | refractory malignant neoplasm | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 1 | NCT02120469 | Oct 2014 → Mar 2019 | triple-negative breast carcinoma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT02171260 | Jul 2014 → Jan 2016 | cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02082626 | Feb 2014 → Jun 2018 | childhood malignant neoplasm, lymphoma | University of Oklahoma | Terminated | No outcome recorded |
| Phase 1 | NCT02014337 | Jan 2014 → Dec 2017 | breast cancer, malignant epithelial tumor of ovary, non-small cell lung carcinoma, prostate cancer +2 | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01795586 | Feb 2013 → Feb 2015 | breast cancer | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT01945710 | Dec 2012 → Oct 2015 | cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01585870 | Jul 2012 → Sep 2015 | neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01432886 | Oct 2011 → Aug 2013 | breast cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03002493 | Dec 2009 → Feb 2011 | neoplasm | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01106248 | Mar 2009 → Sep 2010 | neoplasm | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00908908 | Mar 2009 → May 2011 | cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01000376 | Feb → Aug 2009 | cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00706095 | Feb 2008 → Sep 2009 | cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00415324 | Dec 2006 → May 2014 | cancer of unknown primary site | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00410553 | Nov 2006 → Oct 2012 | ovarian carcinoma, uterine corpus cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00268905 | Oct 2006 → Nov 2011 | cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00326950 | Jun 2006 → Jan 2008 | cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00069264 | Sep 2003 → Mar 2005 | cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00069277 | Aug 2003 → Apr 2005 | cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00047034 | Aug 2002 → Oct 2007 | cancer of unknown primary site | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/224 trials · 1 missed | ||||||
| Phase 1/2 | NCT07811232 | Sep 2026 → Sep 2030 expected | breast neoplasm, endometrium neoplasm, soft tissue sarcoma | Advenchen Pharmaceuticals, LLC. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07494448 | Jul 2026 → Dec 2027 expected | HER2 positive breast carcinoma | MedSIR | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06942234 | Jun 2025 → Jun 2027 expected | Her2-receptor negative breast cancer | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05824975 | May 2023 → Nov 2025 overdue | Her2-receptor negative breast cancer, colorectal cancer, cutaneous melanoma, hepatocellular carcinoma +3 | GI Innovation, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06202261 | Apr 2023 → Dec 2026 expected | breast carcinoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05335473 | May 2022 → May 2025 | Her2-receptor negative breast cancer | Henan Cancer Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT05041101 | Dec 2021 → Sep 2024 | inflammatory breast carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT04345913 | Mar 2021 → Mar 2024 overdue | female breast carcinoma, triple-negative breast carcinoma | National Cancer Institute (NCI) | Active not recruiting | Missed primary |
| Phase 1/2 | NCT04078295 | Sep 2019 → Mar 2027 expected | neoplasm | Eisai Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04061863 | Aug 2019 → Apr 2022 | breast cancer | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT03526679 | Jul 2018 → Jun 2021 | leiomyosarcoma, liposarcoma | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT03424005 | Mar 2018 → Sep 2030 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03245450 | Mar 2018 → May 2021 | Ewing sarcoma, refractory malignant neoplasm, rhabdomyosarcoma | Eisai Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02753595 | Jul 2016 → Aug 2019 | breast cancer | Eisai Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02513472 | Aug 2015 → Jul 2019 | breast neoplasm | Eisai Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02396433 | Apr 2015 | breast cancer | The University of Texas Health Science Center at San Antonio | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT01596751 | Jul 2012 → Jul 2017 | breast cancer | Hope Rugo, MD | Completed | No outcome recorded |
| Phase 1/2 | NCT01744340 | May 2012 → Mar 2015 | colorectal cancer, head and neck cancer | Howard Safran | Completed | No outcome recorded |
| Phase 1/2 | NCT01554371 | Mar 2012 → Dec 2019 | breast carcinoma, peripheral neuropathy | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1/2 | NCT01388647 | Aug 2011 → Jun 2014 | HER2 positive breast carcinoma | Vector Oncology | Terminated | No outcome recorded |
| Phase 1/2 | NCT01126736 | Jun 2010 → Dec 2012 | non-small cell lung carcinoma | Eisai Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT01126749 | Apr 2010 → May 2015 | urinary bladder cancer | Eisai Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT01323530 | Jan 2010 → Jul 2014 | breast cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00365157 | Oct 2006 → Jul 2025 overdue | urothelial carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 288 trials · 2 missed | ||||||
| Phase 2 | NCT07255612 | Nov → Dec 2026 expected | breast cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07520760 | Apr 2026 → Apr 2030 expected | Her2-receptor negative breast cancer | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06889610 | Mar 2026 → Dec 2027 expected | colorectal cancer, melanoma, triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07441512 | Mar 2026 → Mar 2028 expected | triple-negative breast carcinoma | Hu Hai | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07333937 | Dec 2025 → Nov 2027 expected | breast cancer | Xijing Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07205185 | Oct 2025 → Dec 2027 expected | soft tissue sarcoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07657130 | Jul 2025 → Jun 2026 overdue | female breast carcinoma | Liaoning Cancer Hospital & Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06678230 | Nov 2024 → Oct 2025 | breast cancer | The First Hospital of Jilin University | Unknown | No outcome recorded |
| Phase 2 | NCT06449222 | Aug 2024 → Aug 2028 expected | female breast carcinoma, triple-negative breast carcinoma | BioNTech SE | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06533722 | Aug → Sep 2024 | Her2-receptor negative breast cancer | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 2 | NCT06539559 | Aug 2024 → Feb 2026 overdue | breast cancer, metastatic neoplasm | Wang Jiayu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06387628 | Jul 2024 → Apr 2026 overdue | triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06308939 | Mar 2024 → Dec 2025 overdue | breast cancer | Zhejiang Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06202313 | Feb 2024 → Dec 2025 overdue | triple-negative breast carcinoma | Shengjing Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05458674 | Jan 2024 → Jun 2027 expected | breast carcinoma by gene expression profile | Criterium, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05826964 | Jun 2023 → Jul 2026 overdue | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | University of Miami | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05810870 | May 2023 → Apr 2026 overdue | breast cancer | MedSIR | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05619913 | May 2023 → Mar 2025 overdue | ovarian carcinosarcoma, uterine carcinosarcoma | Australia New Zealand Gynaecological Oncology Group | Recruiting | No outcome recorded |
| Phase 2 | NCT05263882 | Mar 2022 → Dec 2023 | Her2-receptor negative breast cancer | Fifth Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05945368 | Feb 2022 → Feb 2024 | HER2 positive breast carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05402722 | Jan → Dec 2022 | triple-negative breast carcinoma | Beijing 302 Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04502680 | Jun 2021 → Jun 2023 | triple-negative breast carcinoma | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT04913571 | May 2021 → Jun 2022 | triple-negative breast carcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT04624711 | Mar 2021 → Jun 2022 | Her2-receptor negative breast cancer | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT05206656 | Oct 2020 → Apr 2022 | breast cancer | Hunan Cancer Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04517292 | Oct 2020 → Jul 2022 | breast cancer | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT04464174 | Oct 2020 → Nov 2023 | triple-negative breast carcinoma | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT05546255 | Jun 2020 → Dec 2022 | triple-negative breast carcinoma | Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT04303741 | Mar 2020 → Nov 2022 | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 2 | NCT03840772 | Jul 2019 → Sep 2024 | solitary fibrous tumor | Italian Sarcoma Group | Completed | No outcome recorded |
| Phase 2 | NCT03899805 | Jun 2019 → Jul 2024 | leiomyosarcoma, liposarcoma, undifferentiated pleomorphic sarcoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT03637868 | Feb 2019 → Apr 2020 | breast cancer | Institut Paoli-Calmettes | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05833919 | Jul 2018 → Jul 2023 | breast cancer | Consorzio Oncotech | Unknown | No outcome recorded |
| Phase 2 | NCT03237780 | Jul 2018 → Jun 2027 expected | renal pelvis urothelial carcinoma, ureter cancer, urethra cancer, urinary bladder carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03441360 | Apr 2018 → Jan 2021 | Ewing sarcoma, rhabdomyosarcoma | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03810976 | Mar 2018 → May 2022 | sarcoma | Yonsei University | Completed | No outcome recorded |
| Phase 2 | NCT03331250 | Jan 2018 → Jul 2023 overdue | angiosarcoma, epithelioid hemangioendothelioma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03222856 | Dec 2017 → Oct 2018 | breast cancer | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT03032614 | Sep 2017 → Mar 2019 | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, breast cancer, ovarian cancer | The University of Texas Health Science Center at San Antonio | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT03202316 | Aug 2017 → Dec 2027 expected | inflammatory breast carcinoma | M.D. Anderson Cancer Center | Active not recruiting | 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 | NCT03051659 | Mar 2017 → Oct 2018 | breast cancer | Dana-Farber Cancer Institute | Completed | Missed primary |
| Phase 2 | NCT03412955 | Mar 2017 → Apr 2020 | breast cancer | Tan Tock Seng Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02640508 | May 2016 → Nov 2020 | cancer | Virginia G. Kaklamani | Completed | No outcome recorded |
| Phase 2 | NCT02623972 | Feb 2016 → May 2021 overdue | Her2-receptor negative breast cancer, inflammatory breast carcinoma | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02581839 | Nov 2015 → Jul 2018 | breast cancer, metastatic malignant neoplasm in the brain | Case Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02681523 | Oct 2015 → Jul 2018 | breast cancer | Imperial College London | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02404506 | Aug 2015 → Dec 2020 | adenocarcinoma, breast cancer | Swiss Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT02481050 | Jun 2015 → Dec 2016 | breast cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02263495 | Dec 2014 → May 2017 | breast cancer | Asan Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02178241 | Dec 2014 → Mar 2019 | carcinoma of urethra, renal pelvis/ureter urothelial carcinoma, ureter carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT02215876 | Sep 2014 → Aug 2017 | breast cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02175446 | Sep 2014 → Dec 2016 | Her2-receptor negative breast cancer | Consorzio Oncotech | Unknown | No outcome recorded |
| Phase 2 | NCT02097238 | Aug 2014 → Jun 2015 | osteosarcoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01908101 | Jan 2014 → May 2019 | female breast carcinoma | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT02035813 | Jan 2014 → Jan 2024 | hormone receptor-positive breast cancer | University of Ulm | Completed | No outcome recorded |
| Phase 2 | NCT02000596 | Jan 2014 → Nov 2015 | breast cancer | University of Maryland, Baltimore | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT01941407 | Nov 2013 → Aug 2014 | breast cancer | ARCAGY/ GINECO GROUP | Completed | No outcome recorded |
| Phase 2 | NCT01912963 | Sep 2013 → Dec 2016 | HER2 positive breast carcinoma | Dana-Farber Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02061085 | Jul 2013 → Dec 2015 | breast neoplasm, metastatic neoplasm | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT01827787 | May 2013 → May 2016 | breast cancer | Dana-Farber Cancer Institute | Completed | Missed primary |
| Phase 2 | NCT01698281 | Dec 2012 → Aug 2014 | breast cancer | AEterna Zentaris | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01705691 | Sep 2012 → Mar 2014 | Her2-receptor negative breast cancer, female breast carcinoma | NSABP Foundation Inc | Completed | No outcome recorded |
| Phase 2 | NCT01676818 | Aug 2012 → Feb 2021 | cervical carcinoma | University of Southern California | Completed | No outcome recorded |
| Phase 2 | NCT01593020 | Aug 2012 → Nov 2020 | female breast carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01669252 | Aug 2012 → Jun 2015 | breast cancer | SOLTI Breast Cancer Research Group | Completed | No outcome recorded |
| Phase 2 | NCT01527487 | Jun 2012 → Sep 2014 | Her2-receptor negative breast cancer | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01613768 | May 2012 → Aug 2017 | salivary gland cancer | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT01534455 | Feb 2012 → Mar 2015 | breast cancer | GBG Forschungs GmbH | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01498588 | Nov 2011 → Jun 2015 | breast cancer | Emory University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01458249 | Nov 2011 → Nov 2014 | soft tissue sarcoma | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01401959 | Sep 2011 → Apr 2017 | breast cancer | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01372579 | Aug 2011 → Jun 2020 | male breast carcinoma, triple-negative breast carcinoma | Northwestern University | Unknown | No outcome recorded |
| Phase 2 | NCT01439282 | Aug 2011 → Nov 2012 | estrogen-receptor positive breast cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01328249 | Mar 2011 → Oct 2014 | Her2-receptor negative breast cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01268150 | Feb 2011 → Mar 2012 | Her2-receptor negative breast cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01269346 | Dec 2010 → Mar 2013 | female breast carcinoma | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01156753 | Jul 2010 → Oct 2012 | breast cancer | Celldex Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00965523 | Jan 2008 → Dec 2010 | breast cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00413192 | Jan 2007 → Jun 2012 | soft tissue sarcoma | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00337077 | Nov 2006 → Jun 2009 | hormone-resistant prostate carcinoma, prostate adenocarcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00400829 | Nov 2006 → Jan 2011 | non-small cell lung carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00383760 | Aug 2006 → Jul 2011 | pancreatic adenocarcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00337129 | May 2006 → Aug 2008 | head and neck cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00334893 | Apr 2006 → Mar 2012 | fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00246090 | Oct 2005 → Sep 2007 | breast cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00100932 | Dec 2004 → Jun 2008 | non-small cell lung carcinoma | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00097721 | Sep 2004 → Nov 2006 | breast cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 319 trials · 7 met primary · 3 missed | ||||||
| Phase 3 | NCT07088263 | Sep 2025 → Jul 2027 expected | breast neoplasm | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT06889688 | Feb 2025 → Dec 2028 expected | triple-negative breast carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT06382142 | Jun 2024 → Jun 2026 overdue | triple-negative breast carcinoma | Sichuan Baili Pharmaceutical Co., Ltd. | Active not recruiting | Met primary |
| Phase 3 | NCT06343948 | Apr 2024 → May 2026 overdue | hormone receptor-positive breast cancer | Sichuan Baili Pharmaceutical Co., Ltd. | Active not recruiting | Met primary |
| Phase 3 | NCT06072612 | Dec 2023 → Dec 2027 expected | breast cancer | BriaCell Therapeutics Corporation | Recruiting | No outcome recorded |
| Phase 3 | NCT03613181 | Dec 2023 → Dec 2024 | Her2-receptor negative breast cancer, malignant leptomeningeal tumor, metastatic malignant neoplasm in the brain, neoplastic meningitis | Angiochem Inc | Unknown | No outcome recorded |
| Phase 3 | NCT05954442 | Sep 2023 → Aug 2025 overdue | triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 3 | NCT06857305 | Jul 2023 → Jul 2026 | breast cancer | Ma Fei，MD | Unknown | No outcome recorded |
| Phase 3 | NCT05347134 | Jun 2022 → Nov 2023 overdue | triple-negative breast carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active not recruiting | Met primary |
| Phase 3 | NCT04579224 | Jun 2021 → Aug 2030 expected | urinary bladder carcinoma, urothelial carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03786094 | May 2019 → Oct 2021 | breast cancer | Spexis AG | Terminated | Missed primary |
| Phase 3 | NCT03264547 | Aug 2017 → Dec 2024 | breast cancer | Japan Breast Cancer Research Group | Completed | Met primary |
| Phase 3 | NCT02344472 | Sep 2015 → Jan 2025 | breast cancer | University of Ulm | Unknown | No outcome recorded |
| Phase 3 | NCT02037529 | Jan 2014 → Feb 2021 | Her2-receptor negative breast cancer, breast adenocarcinoma, invasive breast carcinoma | Academic and Community Cancer Research United | Suspended | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02225470 | Sep 2013 → Sep 2017 | female breast carcinoma, triple-negative breast carcinoma | Eisai Inc. | Completed | Met primary |
| Phase 3 | NCT01454934 | Dec 2011 → May 2014 | non-small cell lung carcinoma | Eisai Inc. | Completed | Missed primary |
| Phase 3 | NCT01327885 | Mar 2011 → Jan 2015 | soft tissue sarcoma | Eisai Inc. | Completed | Met primary |
| Phase 3 | NCT00388726 | Nov 2006 → May 2009 | breast cancer | Eisai Inc. | Completed | Met primary |
| Phase 3 | NCT00337103 | Sep 2006 → Mar 2012 | breast cancer | Eisai Inc. | Completed | Missed primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT05033769 | Mar 2021 → Jul 2023 | female breast carcinoma | Institut fuer Frauengesundheit | Unknown | No outcome recorded |
| Phase 4 | NCT03583944 | Mar 2018 → Jun 2019 | breast neoplasm | Eisai Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02864030 | May 2014 → Dec 2018 | breast cancer, poisoning, toxic polyneuropathy | Oncologia Medica dell'Ospedale Fatebenefratelli | Completed | No outcome recorded |
| Phase 4 | NCT01961544 | Jun 2013 → Jul 2015 | breast cancer | Eisai Co., Ltd. | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01142661 | Aug 2010 → Aug 2011 | breast cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01240421 | Mar 2011 → Mar 2015 | breast cancer | Eisai Inc. | Approved for marketing | No outcome recorded |
| Comparator or background therapy71 trials | ||||||
| Phase 1 | NCT06328738 Background | May 2024 → Jan 2027 expected | HER2 positive breast carcinoma, colorectal cancer | Enliven Therapeutics | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02419495 Background | Jun 2015 → Sep 2024 | cutaneous melanoma, fallopian tube carcinoma, metastatic malignant neoplasm, metastatic melanoma +5 | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT01802970 Background | Dec 2012 → Jan 2017 | breast cancer | Baylor Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT01418677 Comparator | Oct 2011 → Jul 2014 | cancer of unknown primary site | Eisai Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT06775236 Comparator | Mar 2025 → Jun 2027 expected | breast cancer | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT04826016 Background | Mar 2022 | breast cancer | MedSIR | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04711824 Background | Mar 2022 → Jul 2026 overdue | breast cancer, metastatic malignant neoplasm in the brain | Colette Shen | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02723877 Background | Mar 2016 → Oct 2018 | breast cancer | PIQUR Therapeutics AG | Completed | No outcome recorded |
| Phase 2 | NCT07824869 Background | Oct 2026 → Mar 2028 expected | HER2 positive breast carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07203729 Comparator | Mar 2026 → Jun 2030 expected | breast cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT06875128 Background | Jan 2026 → May 2029 expected | — | Delcath Systems Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07007559 Background | Dec 2025 → Dec 2027 expected | breast cancer | ALX Oncology Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT06731153 Background | Dec 2024 → Jun 2027 expected | triple-negative breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06678048 Background | Oct 2024 → Apr 2026 overdue | breast cancer | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06102824 Comparator | Oct 2024 → Jun 2027 expected | Her2-receptor negative breast cancer | Guangdong Provincial People's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06355037 Background | May → Dec 2024 overdue | triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06355024 Background | May 2024 → Jan 2025 | triple-negative breast carcinoma | Fudan University | Completed | No outcome recorded |
| Phase 2 | NCT06099769 Comparator | Oct 2023 → Oct 2027 expected | breast cancer | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05621434 Background | Dec 2022 → Dec 2024 | HER2 positive breast carcinoma | Fujian Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT05570253 Background | Oct 2022 → Oct 2027 expected | triple-negative breast carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05420779 Comparator | Jun 2022 → Dec 2024 | breast carcinoma | Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04986579 Background | Oct 2021 → Jun 2028 expected | breast cancer, chemotherapy-induced alopecia | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04745975 Comparator | Feb 2021 → Jan 2023 | triple-negative breast carcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT04681911 Background | Sep 2020 → Sep 2023 | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05530057 Comparator | Feb 2020 → Jun 2028 expected | breast cancer | Seoul National University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT03795012 Comparator | Apr 2019 → Mar 2021 | breast cancer | MedSIR | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02448420 Comparator | Jul 2015 → Sep 2023 | breast cancer | SOLTI Breast Cancer Research Group | Completed | No outcome recorded |
| Phase 2 | NCT02299999 Comparator | Apr 2014 → Dec 2022 overdue | breast cancer | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01427933 Background | Nov 2011 → Sep 2013 | breast cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01104155 Comparator | Feb 2010 → Apr 2011 | non-small cell lung carcinoma | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00879086 Comparator | Mar 2009 → Apr 2013 | breast cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00278993 Comparator | Jan 2006 → Jan 2008 | prostate cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT07556848 Comparator | May 2026 → Dec 2027 expected | triple-negative breast carcinoma | Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07406542 Comparator | Apr 2026 → Apr 2029 expected | Her2-receptor negative breast cancer | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07533123 Comparator | Mar 2026 → Mar 2029 expected | triple-negative breast carcinoma | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT07461454 Comparator | Mar 2026 → Dec 2027 expected | breast cancer | MediLink Therapeutics (Suzhou) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07173751 Background | Oct 2025 → Dec 2029 expected | breast neoplasm | BioNTech SE | Recruiting | No outcome recorded |
| Phase 3 | NCT06732323 Comparator | Sep 2025 → Jun 2027 expected | triple-negative breast carcinoma | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07047365 Background | Jul 2025 → Jun 2028 expected | HER2 positive breast carcinoma | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06957886 Comparator | May 2025 → May 2027 expected | breast carcinoma by gene expression profile | Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06435429 Background | Aug 2024 → Apr 2028 expected | HER2 positive breast carcinoma | Jazz Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06519370 Comparator | Aug 2024 → Aug 2026 overdue | triple-negative breast carcinoma | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06383767 Comparator | Jul 2024 → Jun 2027 expected | breast cancer | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06263231 Comparator | Jun 2024 → Dec 2027 expected | soft tissue sarcoma | Intensity Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06255392 Comparator | Jun 2024 → Mar 2031 expected | Her2-receptor negative breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT07371910 Comparator | Jun 2024 → Mar 2031 expected | Her2-receptor negative breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06279364 Comparator | Feb 2024 → Jul 2026 overdue | triple-negative breast carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06268652 Comparator | Jan 2024 → Feb 2026 overdue | breast carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT06079983 Comparator | Dec 2023 → Apr 2026 overdue | breast cancer | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT06081959 Comparator | Oct 2023 → Dec 2026 expected | breast cancer | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06143553 Comparator | Sep 2023 → Dec 2025 overdue | breast cancer | Shanghai Yizhong Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05814354 Comparator | Jun 2023 → Jan 2025 | breast cancer | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT05806060 Comparator | Apr 2023 → May 2026 overdue | triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 3 | NCT05760378 Background | Mar 2023 → Jan 2025 overdue | triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 3 | NCT05374512 Comparator | May 2022 → Aug 2025 overdue | breast cancer | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT05134194 Background | Jan 2022 | triple-negative breast carcinoma | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT05104866 Comparator | Oct 2021 → Jul 2024 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05346861 Background | Sep 2021 → Oct 2023 | HER2 positive breast carcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 3 | NCT05063786 Comparator | Sep 2021 → Jun 2026 overdue | breast cancer | Spanish Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04639986 Comparator | Nov 2020 → Dec 2026 expected | breast cancer | Gilead Sciences | Active not recruiting | Met primary |
| Phase 3 | NCT03901339 Comparator | May 2019 → Oct 2023 | breast cancer | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT03734029 Comparator | Dec 2018 → Jan 2022 | breast cancer | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT03262935 Comparator | Dec 2017 → Mar 2021 | breast cancer | Byondis B.V. | Completed | Met primary |
| Phase 3 | NCT02574455 Comparator | Nov 2017 → Mar 2020 | breast cancer | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02915744 Comparator | Nov 2016 → Jul 2020 | breast cancer, metastatic neoplasm | Nektar Therapeutics | Completed | Missed primary |
| Phase 3 | NCT02555657 Comparator | Oct 2015 → Apr 2019 | triple-negative breast carcinoma | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 3 | NCT02492711 Background | Aug 2015 → Aug 2021 | HER2 positive breast carcinoma, metastatic neoplasm | MacroGenics | Completed | Met primary |
| Phase 3 | NCT02514681 Background | Aug 2015 → Dec 2018 | HER2 positive breast carcinoma | Japan Breast Cancer Research Group | Completed | Met primary |
| Phase 3 | NCT02000622 Comparator | Mar 2014 → Dec 2016 | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, breast carcinoma | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01945775 Comparator | Oct 2013 → Sep 2017 | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, breast cancer | Pfizer | Completed | Met primary |
| Phase 3 | NCT01492101 Comparator | Dec 2011 → Apr 2016 | female breast carcinoma | Nektar Therapeutics | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 65
| Date | Issuer | Release |
|---|---|---|
| 2026-06-03 | Lupin Limited | Regulatory Lupin and Natco Receive Approval from U.S. FDA for Eribulin Mesylate Injection lupin.com ↗ |
| 2025-12-02 | SynDevRx, Inc. | Results Aretha-1 Initial Efficacy and Safety Data in mTNBC Patients To Be Presented at SABCS syndevrx.com ↗
Safety Run-in Cohort Results Show Anti-tumor Activity Plus Systemic Metabolic Improvements with Evexomostat Plus Eribulin in Late-line Metastatic TNBC Patients to be Presented at SABCS 2025 |
| 2025-05-24 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Results “国药之光”领衔12大ORAL刷屏ASCO，中国生物制药引领中国创新药企冲刺全球新 cttq.com ↗
研究结果显示，24周无进展生存率为70.0% 、中位无进展生存期为8.5个月。 |
| 2024-12-11 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Regulatory 正大天晴攻克化药“珠峰”，甲磺酸艾立布林注射液获批上市 cttq.com ↗
12月10日，正大天晴研发的甲磺酸艾立布林注射液获得中国国家药品监督管理局（NMPA）颁发的上市许可批件，用于治疗既往接受过至少两种化疗方案（含蒽环类和紫杉烷类药物）的局部晚期或转移性乳腺癌患者。 |
| 2022-09-12 | Eisai Inc. | Results Eisai Presents Results of Post Hoc Analysis of Eribulin Mesylate (HALAVEN®) at the European Society for Medical Oncology (ESMO) Congress 2022 Analysis Evaluates Efficacy of Eribulin in Metastatic HER2-low Breast Cancer Across Three Clinical Studies eisai.com ↗ |
| 2022-01-06 | Knight Therapeutics (USA) Inc | Regulatory Knight Therapeutics Inc. Announces Approval of Halaven® in Colombia knighttx.com ↗
Knight Therapeutics Inc. (TSX:GUD) (“Knight” or “the Company”) announced today that its Colombian affiliate, Biotoscana Farma S.A. has obtained INVIMA approval for Halaven® (eribulin) injection. |
| 2020-09-18 | Eisai Inc. | Results EISAI PRESENTS LATEST DATA OF PHASE I CLINICAL TRIAL ON LIPOSOMAL FORMULATION OF ANTI-CANCER AGENT HALAVEN® (ERIBULIN) AT ESMO VIRTUAL CONGRESS 2020 eisai.com ↗
Additionally, progression-free survival (PFS) was a median of 5.7 months (95% CI: 3.9-8.3), and the median overall survival (OS) was not reached (95% CI: 10.3 – not reached). |
| 2019-12-05 | Eisai Inc. | Results EISAI TO PRESENT NEW RESEARCH ON ERIBULIN (HALAVEN®) AT 42ND ANNUAL SAN ANTONIO BREAST CANCER SYMPOSIUM eisai.com ↗
Absolute lymphocyte count (ALC) is a predictor of eribulin benefit in advanced or metastatic breast cancer (MBC) |
| 2019-07-17 | Eisai Inc. | Regulatory ANTICANCER AGENT HALAVEN® APPROVED FOR TREATMENT OF LOCALLY ADVANCED OR METASTATIC BREAST CANCER IN CHINA eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that Eisai received New Drug Approval for Eisai’s in-house developed anticancer agent Halaven ® (eribulin mesylate) for use in the treatment of patients with locally advanced or metastatic breast cancer, previously treated with at least two prior chemotherapy regimens, including an anthracycline and a taxane, from the China National Medical Products Administration (NMPA). |
| 2018-10-22 | Halozyme Therapeutics | Results Halozyme Provides Summary Results Of Data For PEGPH20 Combination Treatments Presented At ESMO 2018 Congress halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced the presentation of data from two clinical trials for PEGPH20 (pegvorhyaluronidase alfa) in patients with advanced pancreas and metastatic breast cancer. |
| 2017-12-08 | Eisai Inc. | Results UPDATED ANALYSIS OF PHASE Ⅰb/Ⅱ STUDY OF ERIBULIN AND PEMBROLIZUMAB COMBINATION REGIMEN IN METASTATIC TRIPLE-NEGATIVE BREAST CANCER PRESENTED AT SAN ANTONIO BREAST CANCER SYMPOSIUM eisai.com ↗
The combination achieved an ORR of 26.4% (3 patients experienced a complete response and 25 patients experienced a partial response, 95% CI = 18.3-35.9). |
| 2017-11-29 | Eisai Inc. | Regulatory RESUBMITTED NDA FOR ANTICANCER AGENT HALAVEN® ACCEPTED IN CHINA eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the China Food and Drug Administration (CFDA) has accepted for review the resubmitted New Drug Application (NDA) for Eisai's anticancer agent eribulin mesylate (“eribulin”, product name: Halaven®). |
| 2017-09-06 | Eisai Inc. | Results EISAI SIGNS AGREEMENT WITH MERCK & CO., INC., KENILWORTH, NJ, USA TO EXPAND ENROLLMENT OF STUDY FOR HALAVEN® (ERIBULIN) AND PEMBROLIZUMAB COMBINATION DUE TO ENCOURAGING INITIAL DATA IN TRIPLE-NEGATIVE BREAST CANCER eisai.com ↗
The interim analysis results (n = 39) 1 indicated an objective response rate * to the combination therapy of 33.3% (1 patient experienced a complete response and 12 patients experienced a partial response). |
| 2017-06-27 | Eisai Inc. | Regulatory EISAI TEMPORARILY WITHDRAWS NEW DRUG APPLICATION FOR ANTICANCER AGENT HALAVEN® IN CHINA PLANS TO RESUBMIT APPLICATION AFTER PREPARING ADDITIONAL DOCUMENTATION eisai.com ↗ |
| 2016-12-12 | Merck Sharp & Dohme LLC | Results Interim Results from Phase 1b/2 Study Evaluating the Combination of Merck’s KEYTRUDA® (pembrolizumab) and Eisai’s HALAVEN® (eribulin mesylate) Injection in Metastatic Triple-Negative Breast Cancer Presented at 2016 SABCS merck.com ↗
ORR was similar between PD-L1-positive and -negative cohorts [PD-L1 positive=29.4% (n=5/17; 95% CI, 11.1-51.1); PD-L1 negative=33.3% (n=6/18; 95% CI, 14.1-54.6)]. |
| 2016-12-12 | Eisai Inc. | Results INTERIM ANALYSIS OF PHASE Ib/Ⅱ STUDY OF ERIBULIN AND PEMBROLIZUMAB COMBINATION REGIMEN IN METASTATIC TRIPLE NEGATIVE BREAST CANCER PRESENTED AT SAN ANTONIO BREAST CANCER SYMPOSIUM eisai.com ↗
From the results of the study, ORR was 33.3% (1 patient experienced a complete response and 12 patients experienced a partial response). |
| 2016-12-10 | Corcept Therapeutics | Results Corcept Therapeutics Announces Encouraging Results of Phase 1/2 Trial of Mifepristone Plus Eribulin in Triple-Negative Breast Cancer corcept.com ↗
Four patients exhibited a partial response, defined as a 30 percent or greater reduction in tumor size, eight had stable disease and 11 had progressive disease. |
| 2016-11-04 | Eisai Inc. | Regulatory U.K. NICE RECOMMENDS ANTICANCER AGENT HALAVEN® AS TREATMENT FOR ADVANCED BREAST CANCER eisai.com ↗
Eribulin is the first breast cancer treatment to be recommended by NICE since 2007. |
| 2016-08-05 | Eisai Inc. | Regulatory CHINA FOOD AND DRUG ADMINISTRATION ACCEPTS NDA FOR ANTICANCER AGENT HALAVEN® eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the China Food and Drug Administration (CFDA) has accepted for review a New Drug Application (NDA) submitted for Eisai's in-house developed anticancer agent eribulin mesylate (“eribulin”, product name: Halaven®) for use in the treatment of patients with locally advanced or metastatic breast cancer in China. |
| 2016-08-01 | Eisai Inc. | Results EISAI PRESENTS RESULTS OF ADDITIONAL ANALYSIS OF PHASE Ⅲ STUDY OF ANTICANCER AGENT HALAVEN® AT 14TH JSMO ANNUAL MEETING PLENARY SESSION eisai.com ↗
According to the results of these analyses, eribulin demonstrated a trend for extension in overall survival over dacarbazine in each subtype. |
| 2016-06-02 | Corcept Therapeutics | Results Corcept Therapeutics Provides Update of Progress in Cortisol Modulation Oncology Program corcept.com ↗
Preliminary efficacy results in Phase 1/2 trial of mifepristone plus eribulin (Eisai’s Halaven®) to treat triple-negative breast cancer (TNBC) indicate combination is active; final results expected in mid-2016 |
| 2016-06-01 | Eisai Inc. | Regulatory ANTICANCER AGENT HALAVEN® APPROVED IN THE PHILIPPINES FOR NEW INDICATION FOR TREATMENT OF SOFT TISSUE SARCOMA SECOND COUNTRY IN ASIA AFTER JAPAN TO APPROVE HALAVEN FOR SOFT TISSUE SARCOMA eisai.com ↗
The Philippines is the second country in Asia in which Halaven has been approved for the soft tissue sarcoma indication following approval in Japan, the United States and Europe. |
| 2016-05-13 | Eisai Inc. | Results ANTICANCER AGENT HALAVEN® DEMONSTRATES STATISTICALLY SIGNIFICANT EXTENSION IN PROGRESSION FREE SURVIVAL COMPARED TO VINORELBINE IN PHASE Ⅲ CLINICAL STUDY OF PATIENTS WITH BREAST CANCER IN CHINA eisai.com ↗
eribulin demonstrated a statistically significant extension in the study's primary endpoint of progression free survival (PFS) over the comparator treatment vinorelbine. |
| 2016-05-06 | Eisai Inc. | Regulatory EISAI RECEIVES APPROVAL FOR NEW INDICATION FOR ANTICANCER AGENT HALAVEN® FOR TREATMENT OF ADVANCED LIPOSARCOMA IN EUROPE eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its European regional headquarters Eisai Europe Ltd. (Location: U.K.) has received from the European Commission approval for anticancer agent Halaven® (eribulin mesylate) for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease. |
| 2016-04-05 | Eisai Inc. | Regulatory EISAI RECEIVES POSITIVE CHMP OPINION ON NEW INDICATION FOR ANTICANCER AGENT HALAVEN® FOR TREATMENT OF ADVANCED LIPOSARCOMA eisai.com ↗ |
| 2016-02-29 | Eisai Inc. | Regulatory EISAI'S ANTICANCER AGENT HALAVEN® NEWLY APPROVED IN JAPAN FOR TREATMENT OF SOFT TISSUE SARCOMA eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received approval in Japan for its in-house developed anticancer agent Halaven® (eribulin mesylate) as a treatment of patients with soft tissue sarcoma. |
| 2016-02-12 | Eisai Inc. | Results PHASE Ⅲ TRIAL RESULTS OF EISAI'S ANTICANCER AGENT HALAVEN® IN SOFT TISSUE SARCOMA PUBLISHED IN THE LANCET eisai.com ↗
Halaven demonstrated a statistically significant extension in the study's primary endpoint of OS over the comparator treatment dacarbazine (Halaven median OS: 13.5 months vs dacarbazine median OS: 11.5 months; Hazard Ratio (HR) 0.77 [95% CI=0.62-0.95], p=0.0169). |
| 2016-01-29 | Eisai Inc. | Regulatory U.S. FDA APPROVES EISAI’S ANTICANCER AGENT HALAVEN® FOR THE TREATMENT OF ADVANCED LIPOSARCOMA eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its U.S. subsidiary Eisai Inc. has received approval from the U.S. Food and Drug Administration (FDA) of its in-house developed anticancer agent Halaven® (eribulin mesylate) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. |
| 2015-12-14 | Corcept Therapeutics | Results Corcept Therapeutics Announces Initial Efficacy Results in Phase 1/2 Trial of Mifepristone in Combination With Eribulin for the Treatment of Patients With Metastatic Triple-Negative Breast Cancer corcept.com ↗
At SABCS, the trial's investigators presented efficacy data from the 15 patients enrolled to-date with GR-positive TNBC who have been treated with the recommended dose (two patients from the trial's first phase and 13 from its second). |
| 2015-12-09 | Halozyme Therapeutics | Results Halozyme Therapeutics and Eisai to present data evaluating the antitumor effects of PEGPH20 in combination with eribulin mesylate in preclinical breast cancer models halozyme.com ↗
The research showed the potential impact for PEGPH20-mediated hyaluronan (HA) removal on concentrations of eribulin and antitumor effects of breast cancer therapy in preclinical models. |
| 2015-09-29 | Eisai Inc. | Regulatory U.S. FDA GRANTS PRIORITY REVIEW STATUS TO sNDA FOR ANTICANCER AGENT HALAVEN® AS TREATMENT FOR SOFT TISSUE SARCOMA eisai.com ↗ |
| 2015-07-30 | Eisai Inc. | Regulatory EISAI SUBMITS APPLICATIONS FOR ANTICANCER AGENT HALAVEN® SIMULTANEOUSLY IN JAPAN, U.S. AND EUROPE SEEKING NEW INDICATION AS TREATMENT FOR SOFT TISSUE SARCOMA eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has submitted applications to regulatory authorities in Japan, the United States and Europe (MHLW, FDA and EMA respectively) seeking an additional indication for its in-house developed anticancer agent Halaven® (eribulin mesylate) as a treatment for soft tissue sarcoma. |
| 2015-05-30 | Eisai Inc. | Results ANTICANCER AGENT HALAVEN® SHOWS SIGNIFICANT EXTENSION IN OVERALL SURVIVAL IN PHASE Ⅲ STUDY ON SOFT TISSUE SARCOMA Phase Ⅲ data to be presented in a Soft Tissue Sarcoma oral session at ASCO eisai.com ↗
In the study's primary endpoint of overall survival (OS), eribulin demonstrated a statistically significant extension in OS over the comparator treatment dacarbazine (eribulin median OS: 13.5 months vs dacarbazine median OS: 11.5 months, Hazard Ratio (HR) 0.768 [95% CI=0.618-0.954], p=0.017). |
| 2015-05-13 | Corcept Therapeutics | Results Corcept Therapeutics' Mifepristone Combined with Eribulin to Improve Antitumor Activity in Patients with Triple-Negative Breast Cancer corcept.com ↗
today announced results of a multi-center Phase 1/2 dose-escalation study of mifepristone and chemotherapy drug eribulin (Halaven®) that show it is well tolerated and clinically active in patients with triple-negative breast cancer. |
| 2015-02-25 | Eisai Inc. | Results PHASE Ⅲ TRIAL OF ANTICANCER AGENT HALAVEN® IN SOFT TISSUE SARCOMA SHOWS OVERALL SURVIVAL BENEFIT IN PRIMARY ENDPOINT eisai.com ↗
Eribulin, as a single agent, has now demonstrated overall survival benefit in two distinct solid tumor types (metastatic breast cancer and soft tissue sarcomas), following two prior regimens in the advanced setting. |
| 2014-08-08 | Eisai Inc. | Results EISAI ANNOUNCES TOP-LINE PHASE Ⅲ TRIAL RESULTS OF ERIBULIN IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER FOLLOWING AT LEAST TWO PRIOR REGIMENS eisai.com ↗
The preliminary analysis of the study showed that Study 302 did not meet its primary endpoint of improving overall survival (OS); the median OS in both arms was 9.5 months (Hazard Ratio 1.16; p=0.1343). |
| 2014-07-03 | Eisai Inc. | Regulatory EISAI RECEIVES EUROPEAN COMMISSION APPROVAL OF INDICATION EXPANSION FOR ANTICANCER AGENT HALAVEN® FOR ADVANCED BREAST CANCER AFTER ONLY ONE PRIOR CHEMOTHERAPY eisai.com ↗
The approval received from the European Commission is for the expansion of the current indication |
| 2014-06-02 | Eisai Inc. | Results EISAI PRESENTS DATA ON HALAVEN® FROM POOLED ANALYSIS OF OVER 1,800 ADVANCED BREAST CANCER PATIENTS AT 50TH ASCO ANNUAL MEETING SIGNIFICANT IMPROVEMENT IN OVERALL SURVIVAL FOUND IN HER2 NEGATIVE AND TRIPLE NEGATIVE BREAST CANCER PATIENTS eisai.com ↗
Overall, eribulin demonstrated a significant improvement in OS vs control (Hazard Ratio (HR) 0.85; 95% CI: 0.77-0.95; p=0.003; median OS: 15.2 vs 12.8 months). |
| 2014-05-27 | Eisai Inc. | Regulatory EISAI RECEIVES POSITIVE OPINION FROM EMA'S CHMP ON EXPANDING INDICATION OF ANTICANCER AGENT HALAVEN® FOR USE IN EARLIER-LINE TREATMENT OF ADVANCED BREAST CANCER eisai.com ↗ |
| 2013-10-01 | Eisai Inc. | Results EISAI PRESENTS ADDITIONAL ANALYSIS FINDINGS ON HALAVEN® (ERIBULIN) AT EUROPEAN CANCER CONGRESS 2013 eisai.com ↗
Group E recorded a trend favoring extended OS, with a nominal p-value of 0.02 |
| 2013-06-03 | Eisai Inc. | Results EISAI PRESENTS NEW QUALITY OF LIFE FINDINGS IN PATIENTS WITH METASTATIC BREAST CANCER FROM HALAVEN® (ERIBULIN) VERSUS CAPECITABINE STUDY AT 49TH ASCO ANNUAL MEETING eisai.com ↗
The GHS/QOL score results, which indicate overall patient QOL, were shown to improve significantly more for patients administered eribulin versus capecitabine (p=0.048) over the course of treatment. |
| 2013-05-07 | Eisai Inc. | Regulatory EISAI FILES FOR INDICATION EXPANSION OF ANTICANCER AGENT HALAVEN® WITH EUROPEAN MEDICINES AGENCY SEEKS EARLIER-LINE USE IN TREATMENT OF METASTATIC BREAST CANCER eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that its U.K. subsidiary, Eisai Europe Ltd., has filed an application with the European Medicines Agency (EMA) for anticancer agent Halaven® (eribulin mesylate, “eribulin”), requesting an indication expansion of eribulin to contribute to earlier-line treatment of patients with metastatic breast cancer. |
| 2013-04-10 | Eisai Inc. | Results EISAI ANNOUNCES PRECLINICAL RESEARCH FINDINGS SUGGESTING NOVEL INHIBITORY EFFECT ON TUMOR METASTASIS FOR ANTICANCER AGENT HALAVEN® AT AACR 104TH ANNUAL MEETING eisai.com ↗
These findings indicated that eribulin reduces hypoxia by improving blood perfusion in the tumor core. |
| 2012-12-07 | Eisai Inc. | Results PHASE Ⅲ STUDY (STUDY 301) RESULTS OF ANTICANCER AGENT HALAVEN® VERSUS CAPECITABINE IN LOCALLY ADVANCED OR METASTATIC BREAST CANCER PRESENTED AT 2012 SABCS eisai.com ↗
Results from the study demonstrated a trend that favored improved OS with Halaven compared with capecitabine, although the improvement was not statistically significant. |
| 2012-09-07 | Eisai Inc. | Regulatory EISAI RECEIVES APPROVAL TO MARKET ANTICANCER AGENT HALAVEN® IN AUSTRALIA eisai.com ↗
This latest approval of Halaven will now enable late-stage metastatic breast cancer patients with significant unmet medical needs across Australia to access this innovative therapeutic agent. |
| 2012-09-03 | Eisai Inc. | Regulatory EISAI RECEIVES APPROVAL FOR ANTICANCER AGENT HALAVEN® IN SOUTH KOREA eisai.com ↗ |
| 2012-07-10 | Eisai Inc. | Results EISAI ANNOUNCES PRELIMINARY RESULTS OF PHASE Ⅲ STUDY (STUDY 301) OF ANTICANCER AGENT HALAVEN® VERSUS CAPECITABINE IN LOCALLY ADVANCED OR METASTATIC BREAST CANCER eisai.com ↗
Preliminary results showed that the trial did not meet the pre-specified criteria for either of the co-primary endpoints of overall survival (OS) and progression-free survival (PFS). |
| 2012-04-23 | Eisai Inc. | Regulatory GERMAN FEDERAL REGULATOR CONFIRMS ADDITIONAL BENEFIT OF ANTICANCER AGENT HALAVEN® FOR METASTATIC OR LOCALLY ADVANCED BREAST CANCER eisai.com ↗
This assessment by the G-BA affirms the additional benefit of Halaven, and differs from the preliminary assessment by Germany's IQWiG (Institute for Quality and Efficiency in Health Care) 2) published in February in 2012. |
| 2011-12-15 | Eisai Inc. | Regulatory EISAI ANNOUNCES CANADIAN APPROVAL OF ITS ANTICANCER AGENT HALAVEN™ eisai.com ↗
As of December 2011, the agent is approved in 35 countries worldwide including Canada, the most recent approval, the United States, EU member countries, Japan, Switzerland and Singapore. |
| 2011-12-01 | Eisai Inc. | Regulatory EISAI'S CANADIAN SALES SUBSIDIARY CELEBRATES OFFICIAL INTRODUCTION TO CANADA eisai.com ↗
has filed a New Drug Submission (NDS) with the Canadian regulatory authorities for the anticancer agent Halaven® |
| 2011-05-17 | Eisai Inc. | Regulatory EISAI'S HALAVEN® RECEIVES APPROVAL FROM SWISSMEDIC FOR USE IN LATE-STAGE METASTATIC BREAST CANCER eisai.com ↗
The Swismedic approval means that patients in Switzerland will soon be able to benefit from this innovative treatment. |
| 2011-04-22 | Eisai Inc. | Regulatory HALAVEN® RECEIVES APPROVAL IN JAPAN FOR THE TREATMENT OF INOPERABLE AND RECURRENT BREAST CANCER eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that it has received approval to market its novel anticancer Halaven® Injection 1mg (eribulin mesylate) in Japan for the treatment of inoperable and recurrent breast cancer. |
| 2011-03-23 | Eisai Inc. | Regulatory HALAVEN™ (ERIBULIN) RECEIVES EUROPEAN COMMISSION APPROVAL FOR ADVANCED BREAST CANCER eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that it has received approval from the European Commission for Halaven™ (eribulin) for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. |
| 2011-03-03 | Eisai Inc. | Results THE LANCET PUBLISHES RESULTS FROM PIVOTAL STUDY OF EISAI'S HALAVEN® IN PATIENTS WITH LATE-STAGE METASTATIC BREAST CANCER Phase Ⅲ Study Demonstrated that HALAVEN® Met its Primary Endpoint of Overall Survival eisai.com ↗
The study being published is the global phase III clinical study “EMBRACE” (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice vs. Eribulin), which showed that HALAVEN® demonstrated a statistically significant increase in overall survival (OS) in women with late-stage metastatic breast cancer. |
| 2011-02-10 | Eisai Inc. | Regulatory SINGAPORE HSA APPROVES EISAI'S HALAVEN® (ERIBULIN MESYLATE) INJECTION FOR TREATMENT OF METASTATIC BREAST CANCER eisai.com ↗
Following approval in the United States, Singapore is the second country in the world in which HALAVEN® has been approved. |
| 2011-01-24 | Eisai Inc. | Regulatory HALAVEN™ RECEIVES CHMP POSITIVE OPINION FOR USE IN METASTATIC BREAST CANCER CHMP Opinion Based on Positive EMBRACE Study Data eisai.com ↗ |
| 2010-11-16 | Eisai Inc. | Regulatory U.S. FDA APPROVES EISAI’S HALAVEN™ (ERIBULIN MESYLATE) INJECTION FOR TREATMENT OF METASTATIC BREAST CANCER New Treatment Synthetically Derived From a Sea Sponge (Halichondria okadai) Demonstrated a Statistically Significant Improvement in Overall Survival in Late-Stage Metastatic Breast Cancer eisai.com ↗ |
| 2010-08-30 | Eisai Inc. | Regulatory EISAI ANNOUNCES EXTENSION OF FDA REVIEW OF DRUG APPLICATION FOR INVESTIGATIONAL AGENT ERIBULIN MESYLATE eisai.com ↗
The extension is a result of the agency classifying recent responses to questions regarding the chemistry, manufacturing and controls (CMC) section of the NDA as a major amendment to the NDA. |
| 2010-06-23 | Eisai Inc. | Regulatory EISAI'S INVESTIGATIONAL ANTICANCER AGENT ERIBULIN MESYLATE (E7389) RECEIVES PRIORITY REVIEW STATUS IN JAPAN eisai.com ↗
On May 28, 2010 (U.S. Eastern Standard Time), eribulin was granted priority review status in the United States by the U.S. Food and Drug Administration (FDA). |
| 2010-06-07 | Eisai Inc. | Results PHASE Ⅲ STUDY RESULTS SHOWED EISAI'S ERIBULIN MESYLATE SIGNIFICANTLY IMPROVED OVERALL SURVIVAL IN PATIENTS WITH LOCALLY RECURRENT OR METASTATIC BREAST CANCER Global EMBRACE Study Compared Eribulin to Treatment of Physician's Choice eisai.com ↗ |
| 2010-06-01 | Eisai Inc. | Regulatory EISAI'S INVESTIGATIONAL ANTICANCER AGENT ERIBULIN MESYLATE (E7389) RECEIVES PRIORITY REVIEW STATUS IN THE UNITED STATES eisai.com ↗ |
| 2010-03-31 | Eisai Inc. | Regulatory Eisai Submits Regulatory Applications for Investigational Anticancer Agent Eribulin Mesylate (E7389) in Japan, the United States and Europe eisai.com ↗
announced today that it has submitted regulatory applications for approval of eribulin mesylate |
| 2009-10-30 | Eisai Inc. | Results GLOBAL PHASE Ⅲ STUDY RESULTS SHOW ERIBULIN MEETS PRIMARY ENDPOINT OF OVERALL SURVIVAL Eisai Plans to Submit Marketing Authorization Applications for Eribulin Mesylate in Locally Advanced or Metastatic Breast Cancer eisai.com ↗
Preliminary results from the study demonstrated a statistically significant improvement in overall survival, the primary endpoint, in eribulin-treated patients compared with the physician’s choice of therapy. |
| 2009-07-27 | Eisai Inc. | Regulatory Eisai Files Submission to Health Authorities in Switzerland for E7389, Novel Anti-cancer Agent, for the Treatment of Metastatic and Locally Advanced Breast Cancer eisai.com ↗
This submission was made with data derived primarily from Study 211 (Phase Ⅱ trial). |
| 2008-05-16 | Eisai Inc. | Results E7389 Demonstrated Anti-tumor Activity in Heavily Pretreated Patients with Advanced Breast Cancer Phase Ⅱ Data Presented at ASCO Showed Acceptable Tolerability Profile, with Low Incidence of Grade 3 and 4 Neuropathy eisai.com ↗
The study also suggests that E7389 has a manageable tolerability profile, with a low incidence of Grade 3 (severe) and no Grade 4 (disabling or life-threatening ) neuropathy. |
All press releases naming this drug 92 releases
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 256 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Eribulin | “Any of the following single-agent chemotherapy may be given at the discretion of the investigator, with a cycle length not to exceed four weeks: Capecitabine, Vinorelbine,...” NCT01156753 ↗216“Participants will receive 6 cycles of a standard intravenous or oral chemotherapy regimen or an Antibody-Drug Conjugate (ADC), selected by the investigator from...” NCT07371910 ↗ “Eribulin mesylate (Halaven®) is a novel inhibitor of microtubule dynamics that has demonstrated a survival benefit in patients with locally recurrent or metastatic breast...” PMID 25242374 ↗ Sep 2014 “Patients in the TPC arm of the study will be treated with one or a combination of the following: carboplatin, taxanes, capecitabine, gemcitabine, vinorelbine or eribulin in...” NCT06072612 ↗ “The study is aimed to evaluate the efficacy of investigator's choice (ICC) of chemotherapy (nab-paclitaxel, capecitabine, eribulin, carboplatin, vinorelbine, or utidelone)...” NCT05954442 ↗ “Participants will receive investigator's choice of chemotherapy determined prior to randomization from 1 of the 4 allowed regimens as per protocol: eribulin, or vinorelbine or...” NCT07556848 ↗ “Taxanes (paclitaxel, docetaxel, liposomal paclitaxel, nabpaclitaxel), vinorelbine, capecitabine, eribulin, and other chemotherapeutic agents indicated in advanced breast cancer...” NCT05621434 ↗ “One of the following Treatment of Physician Choice will be administered per standard of care: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel” NCT01492101 ↗ “A simulated dose reduction to eribulin 1.1 mg/m(2) in patients with moderate or severe renal impairment achieved the same exposure as 1.4 mg/m(2) in those with normal renal function.” PMID 26433580 ↗ Oct 2015 “PURPOSE: We report the dose-escalation part of a phase I study of liposomal eribulin (E7389-LF) in Japanese patients with advanced solid tumors and no alternative standard therapy.” PMID 35180771 ↗ May 2022 “Chemotherapy: Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs” NCT07047365 ↗ |
| Known as | B-1939 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1683590 ↗ |
| Known as | E-7389 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1683590 ↗ |
| Known as | E7389 | “Eribulin mesylate (eribulin; E7389) administered as a 2-5 minute intravenous (IV) bolus in one of two dosing schedules for both the Phase Ib and Phase 2 portions: either Days 1...” NCT01126736 ↗18“Eribulin mesylate (E7389), a synthetic analog of the marine macrolide halichondrin B, is a microtubule inhibitor with a unique tubulin binding site and mechanism of action.” PMID 20450446 ↗ Jun 2010 “An Open-Label Phase I Study to Assess the Effect of Rifampicin on the Pharmacokinetics of Eribulin Mesylate (E7389) in Subjects With Advanced Solid Tumors” NCT03002493 ↗ “Eribulin mesylate (E7389) is a synthetic analog of Halichondrin B (HalB), a large polyether macrolide isolated from a marine sponge.” NCT01534455 ↗ “Eribulin mesylate (E7389) is a nontaxane microtubule dynamics inhibitor with a novel mechanism of action.” PMID 20299316 ↗ Apr 2010 “Eribulin mesylate (Halaven™, E7389) is a synthetic analog of the marine natural product halichondrin B” PMID 21887501 ↗ Sep 2011 “eribulin mesylate (E7389) has an impact on the electrocardiogram (ECG)” NCT01106248 ↗ “E7389 (Eribulin Mesylate)” NCT02225470 ↗ |
| Known as | E7389-LF | “PURPOSE: We report the dose-escalation part of a phase I study of liposomal eribulin (E7389-LF) in Japanese patients with advanced solid tumors and no alternative standard therapy.” PMID 35180771 ↗ May 2022 |
| Known as | ER-086526 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1683590 ↗ |
| Known as | Eribulin (as mesylate) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1683590 ↗ |
| Known as | Eribulin (Eri) | “Eribulin (Eri)” NCT03262935 ↗ |
| Known as | Eribulin baxter | ChEMBL registry synonym — accepted as the source's own label CHEMBL1683590 ↗ |
| Known as | Eribulin Mcsilate | “Eribulin Mcsilate Injection” NCT07533123 ↗ |
| Known as | eribulin mesilate | “In phase 1b (dose escalation), patients with advanced, treatment-refractory, solid tumours received eribulin mesilate intravenously in 21-day cycles according to schedule 1...” PMID 30783204 ↗ Feb 20194“Eribulin mesilate 1.1mg/m2 i.v. will be administered intravenously every 3 weeks on day 1 and day 8 until progressive disease.” NCT02404506 ↗ “Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial.” PMID 30928806 ↗ Mar 2019 “Eribulin mesilate is a non-taxane microtubule dynamics inhibitor with a novel mode of action.” PMID 21376385 ↗ Mar 2011 “patients to receive eribulin mesilate (1·4 mg/m(2) intravenously on days 1 and 8)” PMID 26874885 ↗ Feb 2016 |
| Known as | Eribulin mesiylate | “Eribulin mesiylate 1.1mg/m2 d1, 8 every 3 weeks until Progressive disease PD” NCT02404506 ↗ |
| Known as | eribulin mesylate | “Eribulin mesylate (eribulin; E7389) administered as a 2-5 minute intravenous (IV) bolus in one of two dosing schedules for both the Phase Ib and Phase 2 portions: either Days 1...” NCT01126736 ↗52“Eribulin mesylate (Halaven®) is a novel inhibitor of microtubule dynamics that has demonstrated a survival benefit in patients with locally recurrent or metastatic breast...” PMID 25242374 ↗ Sep 2014 “To determine the safety and tolerability of everolimus and eribulin (eribulin mesylate), and determine the recommended Phase IB dose (RP2D) of the drug combination in patients...” NCT02120469 ↗ “This phase II trial is studying how well eribulin mesylate (E7389; Halichondrin B Analog) works in treating patients with metastatic prostate cancer that did not respond to...” NCT00337077 ↗ “Evaluate the antitumor activity of E7389 (eribulin mesylate), in terms of objective response rate, in patients with recurrent or progressive stage IIIB or IV non-small cell lung cancer.” NCT00400829 ↗ “Administration of eribulin mesylate at a dose of 1.4 mg/m\^2 as an IV bolus infusion over 2-5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days.” NCT01458249 ↗ “After completion of 4 cycles of AC, each subject will begin 4 cycles of eribulin mesylate 1.4 mg/m2 intravenously over 2 to 5 minutes on Days 1 and 8 of every 21 day cycle.” NCT01328249 ↗ “Eribulin mesylate (E7389), a synthetic analog of the marine macrolide halichondrin B, is a microtubule inhibitor with a unique tubulin binding site and mechanism of action.” PMID 20450446 ↗ Jun 2010 “Eribulin Mesylate: A dose of 1.4 mg/m\^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.” NCT01142661 ↗ “Eribulin mesylate is developed from a natural substance found in a sea sponge. Eribulin mesylate works by preventing cancer cells from multiplying” NCT03051659 ↗ “Eribulin mesylate (halichondrin B analog E7389) in platinum-resistant and platinum-sensitive ovarian cancer: a 2-cohort, phase 2 study.” PMID 21935916 ↗ Sep 2011 |
| Known as | Eribulin monomethanesulfonate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1683590 ↗ |
| Known as | Eribulin: Halaven | “Eribulin: Halaven” NCT01802970 ↗ |
| Known as | Eribulina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1683590 ↗ |
| Known as | Eribuline | ChEMBL registry synonym — accepted as the source's own label CHEMBL1683590 ↗ |
| Known as | Halaven | “Eribulin mesylate (Halaven®) is a novel inhibitor of microtubule dynamics that has demonstrated a survival benefit in patients with locally recurrent or metastatic breast...” PMID 25242374 ↗ Sep 20144“COMBINATION OF ERIBULIN (HALAVEN®) + BEVACIZUMAB (AVASTIN®) AS A FIRST LINE TREATMENT IN PATIENTS WITH METASTATIC HER2- BREAST CANCER” NCT01941407 ↗ “Eribulin mesylate (Halaven™, E7389) is a synthetic analog of the marine natural product halichondrin B” PMID 21887501 ↗ Sep 2011 “Eribulin (Halaven®): 1.4 mg/m2 on days 1 and 8 of a 21-day cycle” NCT02492711 ↗ “Drug: Eribulin Injection [Halaven]” NCT05033769 ↗ |
| Known as | HALAVEN, Eribulin mesylate | “HALAVEN, Eribulin mesylate” NCT05810870 ↗ |
| Known as | Mevlyq | ChEMBL registry synonym — accepted as the source's own label CHEMBL1683590 ↗ |
| Known as | NSC# 707389 | “A Phase II Study of Eribulin (NSC# 707389) in Recurrent or Refractory Osteosarcoma” NCT02097238 ↗ |
| Action | Inhibit | “Eribulin mesylate is a tubulin inhibitor” PMID 21935916 ↗ Sep 2011 |
| Modality | Small molecule | “is a synthetic analog of the marine natural product halichondrin B” PMID 21887501 ↗ Sep 2011 |
| Route | Intravenous | “Given IV” NCT00047034 ↗ |