Drugs / Trametinib
Trametinib
also known as
GSK1120212 · Mekinist · Trametinib Dimethyl Sulfoxide · GSK1120212B · MEK Inhibitor Trametinib GSK1120212 · MEKINISTR · TMT212
Small molecule targets BRAF, HRAS, KRAS, MAP2K1, MAP2K2, NF1, NRAS, PTPN11 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn melanomatosis 2 milestones | |||||
| Withdrawn | EU (EMA) | Mekinist | melanomatosis | 2014-03-26 | “today announced that it has withdrawn its Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for the use of Mekinist (trametinib)” gsk.com ↗ |
| Filed | EU (EMA) | — | melanomatosis | 2013-02-07 | “today announced submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) for trametinib (MEK)” gsk.com ↗ |
| Filed metastatic melanoma 2 milestones | |||||
| Filed | EU (EMA) | Tafinlar/Mekinist | metastatic melanoma | — | “Tafinlar/Mekinist: demandes d'homologation déposées en Europe et au Japon pour le mélanome métastatique” novartis.com ↗ “Zulassungsanträge für Tafinlar/Mekinist bei metastasierendem Melanom in Europa und Japan eingereicht” novartis.com ↗ “Applications for Tafinlar/Mekinist in metastatic melanoma submitted in Europe and Japan” novartis.com ↗ |
| Filed | Japan (PMDA) | Tafinlar/Mekinist | metastatic melanoma | — | “Tafinlar/Mekinist: demandes d'homologation déposées en Europe et au Japon pour le mélanome métastatique” novartis.com ↗ “Zulassungsanträge für Tafinlar/Mekinist bei metastasierendem Melanom in Europa und Japan eingereicht” novartis.com ↗ “Applications for Tafinlar/Mekinist in metastatic melanoma submitted in Europe and Japan” novartis.com ↗ |
| Filed non-small cell lung carcinoma 2 milestones | |||||
| Filed | EU (EMA) | — | non-small cell lung carcinoma | 2016-10-25 | “Tafinlar + Mekinist (dabrafenib + trametinib) combination therapy was filed with the EMA” novartis.com ↗ |
| Filed | Other | — | non-small cell lung carcinoma | 2016-10-25 | “Tafinlar + Mekinist (dabrafenib + trametinib) combination therapy was filed with the EMA and Swissmedic” novartis.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | MEKINIST | — | 2025-03-07 | fda.gov ↗ |
| Approved | US (FDA) | MEKINIST | — | 2023-03-16 | fda.gov ↗ |
| Approved | EU (EMA) | Mekinist | — | 2014-06-30 | europa.eu ↗ |
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US approved 2023
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03085056 | Mar 2017 → Sep 2026 overdue | thyroid gland undifferentiated (anaplastic) carcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 0 | NCT01467310 | Jan 2012 → Mar 2016 | breast cancer | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 176 trials · 1 met primary | ||||||
| Phase 1 | NCT06962254 | May 2025 → Mar 2028 expected | — | China Medical University Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT06804824 | Feb 2025 → Aug 2027 expected | cancer | Vividion Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05907304 | Aug 2023 → Jul 2025 overdue | — | Erasca, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05440942 | Jan 2023 → May 2025 | pancreatic ductal adenocarcinoma | Peter Hosein, MD | Completed | No outcome recorded |
| Phase 1 | NCT05668585 | Dec 2022 → Nov 2025 | melanoma, non-small cell lung carcinoma | C4 Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04454476 | Nov 2022 → Dec 2024 overdue | gastric cancer, gastric intestinal metaplasia | Vanderbilt-Ingram Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05435846 | Aug 2022 → Nov 2023 | non-small cell lung carcinoma | Collin Blakely | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05616923 | Nov 2021 → Dec 2022 | rosacea | Albany Research Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05048134 | Oct 2021 → Feb 2023 | cancer | Jiangsu HengRui Medicine Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04967079 | Aug 2021 → Jul 2023 | non-small cell lung carcinoma | Shanghai Chest Hospital | Completed | No outcome recorded |
| Phase 1 | NCT04892017 | Jun 2021 → Mar 2026 | metastatic neoplasm, non-small cell lung carcinoma | Deciphera Pharmaceuticals, LLC | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04485559 | Dec 2020 → Dec 2027 expected | grade II glioma, high grade astrocytic tumor | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 1 | NCT03975231 | Sep 2020 → Oct 2027 expected | thyroid gland undifferentiated (anaplastic) carcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04294160 | Jul 2020 → Sep 2024 | colorectal cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04185883 | Dec 2019 → Dec 2026 expected | cancer | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04111458 | Nov 2019 → Mar 2027 expected | — | Boehringer Ingelheim | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03631953 | Sep 2019 → Jan 2026 overdue | meningioma | Assistance Publique Hopitaux De Marseille | Recruiting | No outcome recorded |
| Phase 1 | NCT03272464 | May → Jul 2019 | melanoma | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03825289 | Jan 2019 → Jan 2025 | malignant pancreatic neoplasm, metastatic carcinoma | University of Utah | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03714958 | Dec 2018 → Sep 2023 | colorectal cancer, metastatic malignant neoplasm | Centre Leon Berard | Completed | No outcome recorded |
| Phase 1 | NCT04303403 | Jul 2018 → Jun 2023 | colorectal cancer, pancreatic adenocarcinoma | National Cancer Centre, Singapore | Unknown | No outcome recorded |
| Phase 1 | NCT03501368 | Jun 2018 → Oct 2022 | melanoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT03299088 | Jun 2018 → Jan 2021 | non-small cell lung carcinoma | Jonathan Riess | Completed | No outcome recorded |
| Phase 1 | NCT03516214 | Apr 2018 → Sep 2022 | bronchial neoplasm | University of Cologne | Completed | No outcome recorded |
| Phase 1 | NCT03317119 | Apr 2018 → Jul 2023 | colon carcinoma, rectal carcinoma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT03434262 | Mar 2018 → Sep 2022 | IDH-wildtype glioblastoma, RELA fusion-positive ependymoma, anaplastic ependymoma, anaplastic ganglioglioma +19 | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 1 | NCT03333343 | Jan 2018 → Oct 2026 expected | non-small cell lung carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03065387 | Oct 2017 → Oct 2028 expected | metastatic malignant neoplasm, refractory malignant neoplasm | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03087448 | Sep 2017 → Apr 2022 | non-small cell lung carcinoma | University of California, San Francisco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03088176 | Jun 2017 → Nov 2020 | melanoma | West Cancer Center | Unknown | No outcome recorded |
| Phase 1 | NCT03091257 | Jun 2017 → Jul 2026 overdue | plasma cell myeloma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02939846 | May 2017 → Aug 2018 | cancer | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT02447939 | May 2017 → Oct 2018 | melanoma | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT02974725 | Feb 2017 → Apr 2024 | melanoma, non-small cell lung carcinoma | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02705963 | Oct 2016 → Aug 2019 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02915666 | Oct 2016 → Jul 2017 | melanoma | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02900664 | Aug 2016 → Mar 2021 | colorectal cancer, non-small cell lung carcinoma, triple-negative breast carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02703571 | Jun 2016 → Sep 2019 | colorectal cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02292732 | Feb 2016 → May 2017 | cancer | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT02300935 | Dec 2015 → Jan 2016 | melanoma | SCRI Development Innovations, LLC | Withdrawn | No outcome recorded |
| Phase 1 | NCT02538627 | Aug 2015 → Oct 2016 | colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung carcinoma | Merrimack Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02357732 | Aug 2015 | metastatic melanoma | University of Pittsburgh | Withdrawn | No outcome recorded |
| Phase 1 | NCT02258607 | Mar 2015 → Jul 2016 | — | Sierra Oncology LLC - a GSK company | Terminated | No outcome recorded |
| Phase 1 | NCT02292173 | Feb 2015 → Dec 2018 | hepatocellular carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT02138292 | Jul 2014 → Feb 2017 | melanoma | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT02097225 | May 2014 → Mar 2019 | cutaneous melanoma, metastatic malignant neoplasm, metastatic melanoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT02015117 | Apr 2014 → Jul 2020 overdue | metastatic malignant neoplasm in the brain | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02065063 | Apr 2014 → Jun 2016 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02016729 | Apr 2014 → Apr 2017 | acute myeloid leukemia | Kartos Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02070549 | Mar 2014 → Dec 2024 | metastatic malignant neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT02027961 | Dec 2013 → Apr 2018 | melanoma | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT01938443 | Nov 2013 → Jun 2016 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01912625 | Oct 2013 → Nov 2017 | non-small cell lung carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01938456 | Oct 2013 → Jul 2014 | non-small cell lung carcinoma | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT01935973 | Sep 2013 → Sep 2015 | endometrial clear cell adenocarcinoma, endometrial mixed adenocarcinoma, endometrial serous adenocarcinoma, endometrial undifferentiated carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01940809 | Aug 2013 → Jul 2020 | cutaneous melanoma, metastatic melanoma | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01767454 | Feb 2013 → Sep 2015 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01725100 | Feb 2013 → Jan 2015 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01740648 | Nov 2012 → Sep 2021 | rectal carcinoma | Ohio State University Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01658553 | Sep 2012 → Apr 2014 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01647659 | Jul → Nov 2012 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01476137 | Oct 2011 → Mar 2013 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01438554 | Oct 2011 → Apr 2016 | cholangiocarcinoma, soft tissue sarcoma, thyroid cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 1 | NCT01416337 | Jun → Dec 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01371487 | May → Sep 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01387204 | Feb → Jul 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01324258 | Jan 2011 → Jul 2013 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01248858 | Dec 2010 → Jan 2014 | cancer | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 1 | NCT01192165 | Sep 2010 → Oct 2013 | cancer | GlaxoSmithKline | Completed | Met primary |
| Phase 1 | NCT01138085 | May 2010 → Nov 2014 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01287546 | Apr 2010 → Jan 2015 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01155453 | Apr 2010 → Nov 2014 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00955773 | Aug 2009 → Nov 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01428427 | Aug 2009 → Jul 2011 | acute myeloid leukemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00687622 | Jul 2008 → Jun 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/233 trials · 1 met primary · 1 missed | ||||||
| Phase 1/2 | NCT07468071 | Jun 2026 → Jun 2029 expected | — | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05275374 | Dec 2025 → Dec 2027 expected | colorectal cancer, melanoma, non-small cell lung carcinoma, thyroid cancer | Xynomic Pharmaceuticals, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07072403 | Jul 2025 → Jul 2027 expected | vascular malformation | West China Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06712875 | Apr 2025 → Dec 2028 expected | low grade glioma | Ann & Robert H Lurie Children's Hospital of Chicago | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05849662 | Oct 2024 → Dec 2028 expected | CBL-related disorder, juvenile myelomonocytic leukemia, neurofibromatosis type 1 | Therapeutic Advances in Childhood Leukemia Consortium | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06456138 | Jul 2024 → Jun 2026 overdue | non-small cell lung carcinoma, refractory malignant neoplasm | Shanghai Chest Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05658640 | Nov 2023 → Apr 2029 expected | T-lymphoblastic lymphoma, acute lymphoblastic leukemia | Princess Maxima Center for Pediatric Oncology | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05874414 | Aug 2023 → Dec 2027 expected | cholangiocarcinoma | Genfit | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05677373 | Jan 2023 → Jul 2025 | uveal melanoma | Alliance for Clinical Trials in Oncology | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05358249 | Oct 2022 → Sep 2026 overdue | colorectal carcinoma, non-small cell lung carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05372354 | Oct 2022 → Oct 2026 expected | plasma cell myeloma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05071183 | Sep 2021 → Mar 2023 | metastatic neoplasm | Turning Point Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT04557956 | Aug 2021 → Oct 2025 overdue | cutaneous melanoma, metastatic melanoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04326283 | Apr 2020 → Apr 2023 | amyotrophic lateral sclerosis | Genuv Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT04201457 | Jan 2020 → Oct 2026 expected | low grade glioma | Pediatric Brain Tumor Consortium | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03704688 | Oct 2018 → Feb 2022 | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT03455764 | Sep 2018 → Sep 2023 | melanoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT03580382 | Jul → Sep 2018 | melanoma | NYU Langone Health | Terminated | No outcome recorded |
| Phase 1/2 | NCT03225664 | Feb 2018 → Dec 2027 expected | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03377361 | Jan 2018 → Nov 2024 | colorectal carcinoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT03754179 | Jan 2018 → Dec 2021 | melanoma | University Hospital Brussels | Unknown | No outcome recorded |
| Phase 1/2 | NCT03076164 | Mar 2017 → Dec 2020 | lung adenocarcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02580708 | Sep 2015 → May 2016 | non-small cell lung carcinoma | Clovis Oncology, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02392871 | May 2015 → Sep 2019 | metastatic melanoma | Melanoma and Skin Cancer Trials Limited | Completed | No outcome recorded |
| Phase 1/2 | NCT02124772 | Jan 2015 → Dec 2020 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT02230553 | Oct 2014 → Jul 2019 | colorectal cancer | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02257424 | Oct 2014 → Oct 2021 | melanoma | Abramson Cancer Center at Penn Medicine | Completed | Missed primary |
| Phase 1/2 | NCT02143050 | Sep 2014 → Nov 2017 | melanoma | University of Louisville | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02130466 | May 2014 → Jul 2021 | cancer, melanoma | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 1/2 | NCT02079740 | Mar 2014 → Dec 2022 overdue | metastatic malignant neoplasm, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01989585 | Mar 2014 → Dec 2027 expected | cutaneous melanoma, metastatic melanoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01902173 | Oct 2013 → May 2018 | cutaneous melanoma, hematopoietic and lymphoid cell neoplasm, metastatic malignant neoplasm, metastatic melanoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/2 | NCT01750918 | Dec 2012 → Jun 2020 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2119 trials · 6 met primary · 8 missed | ||||||
| Phase 2 | NCT07802418 | Oct 2026 → Jun 2031 expected | malignant pancreatic neoplasm | Herlev Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07477457 | Mar 2026 → Mar 2028 expected | metastatic neoplasm, osteosarcoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07110246 | Nov 2025 → Mar 2032 expected | low grade glioma | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 2 | NCT07549646 | Aug 2025 → Aug 2029 expected | vascular malformation | Children's Hospital of Philadelphia | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07022834 | Jun 2025 → Jun 2028 expected | Langerhans cell histiocytosis | West China Second University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06933394 | May 2025 → May 2031 expected | neuroblastoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06119789 | Mar 2025 → Nov 2033 expected | high grade malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06967155 | Mar 2025 → Nov 2027 expected | neoplasm | Blokhin's Russian Cancer Research Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06563999 | Nov 2024 → Nov 2027 expected | lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06739395 | Nov 2024 → Dec 2026 expected | cancer | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Show all 119 trials opens the full record — a long page | ||||||
| Phase 2/34 trials · 1 met primary | ||||||
| Phase 2/3 | NCT07440290 | Feb 2026 → Oct 2029 expected | Erdheim-Chester disease, Langerhans cell histiocytosis, colorectal neoplasm, digestive system cancer +9 | Cancer Research UK | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06819605 | Mar 2025 → Oct 2028 expected | ameloblastoma | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT05722886 | Mar 2023 → Oct 2029 expected | cancer, hematopoietic and lymphoid cell neoplasm | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 2/3 | NCT02101788 | Apr 2014 → Apr 2019 | borderline ovarian serous tumor, micropapillary serous carcinoma, ovarian serous adenocarcinoma, primary peritoneal serous adenocarcinoma | National Cancer Institute (NCI) | Completed | Met primary |
| Phase 39 trials · 6 met primary | ||||||
| Phase 3 | NCT07817186 | Aug 2027 → Jun 2032 expected | Noonan syndrome and Noonan-related syndrome, heart failure | Carelon Research | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06346067 | Apr 2024 → Apr 2028 expected | melanoma | Erasca, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04940052 | Nov 2021 → Jan 2025 overdue | differentiated thyroid carcinoma | Novartis Pharmaceuticals | Active not recruiting | Met primary |
| Phase 3 | NCT03784014 | Oct 2019 → Dec 2023 | soft tissue sarcoma | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 3 | NCT03551626 | Aug 2018 → Oct 2020 | melanoma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01682083 | Jan 2013 → Jun 2017 | melanoma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01597908 | Jun 2012 → Apr 2014 | melanoma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01584648 | May 2012 → Aug 2013 | melanoma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01245062 | Nov 2010 → Oct 2011 | melanoma | GlaxoSmithKline | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07010393 | Jul 2025 → Dec 2027 expected | thyroid tumor | Fujian Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06195228 | Jan 2020 → Dec 2026 expected | — | Fudan University | Recruiting | No outcome recorded |
| Phase 4 | NCT03975829 | Nov 2019 → Nov 2026 expected | Lhermitte-Duclos disease, anaplastic astrocytoma, anaplastic ganglioglioma, anaplastic oligodendroglioma +16 | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03340506 | Jan 2018 → Dec 2032 expected | glioma, melanoma, non-small cell lung carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT05063058 | Jan 2016 → Nov 2019 | melanoma | Charite University, Berlin, Germany | Completed | No outcome recorded |
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| Phase not stated4 trials | ||||||
| — | NCT04489433 | — | melanoma | Novartis Pharmaceuticals | No longer available | No outcome recorded |
| — | NCT04544202 | — | melanoma | Novartis Pharmaceuticals | No longer available | No outcome recorded |
| — | NCT02416232 | — | cutaneous melanoma | GlaxoSmithKline | No longer available | No outcome recorded |
| — | NCT03386071 | — | castration-resistant prostate carcinoma | Jonsson Comprehensive Cancer Center | No longer available | No outcome recorded |
| Comparator or background therapy13 trials | ||||||
| Phase 1 | NCT04903119 Background | Jun 2022 → Jul 2028 expected | metastatic melanoma | Rina Plattner | Recruiting | No outcome recorded |
| Phase 1 | NCT03026517 Background | Jan 2017 → Jan 2025 | melanoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02110355 Background | Dec 2014 → Dec 2018 | cancer, melanoma | Kartos Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01231594 Background | Nov 2010 → Apr 2018 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT02872259 Comparator | Feb 2017 → May 2024 | melanoma | Haukeland University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT05370807 Background | Oct 2022 → Dec 2026 expected | metastatic melanoma | University Hospital Brussels | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04527549 Background | Jun 2021 → Jan 2024 | cutaneous melanoma | ECOG-ACRIN Cancer Research Group | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04238624 Background | Jan 2020 → Jun 2027 expected | thyroid gland undifferentiated (anaplastic) carcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01990196 Comparator | Sep 2014 → Sep 2024 overdue | prostate cancer | Jonsson Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06475989 Comparator | Dec 2024 → Sep 2030 expected | differentiated thyroid carcinoma | ECOG-ACRIN Cancer Research Group | Recruiting | No outcome recorded |
| Phase 3 | NCT02967692 Background | Feb 2017 → Aug 2020 | melanoma | Novartis Pharmaceuticals | Terminated | Missed primary Stop: Business |
| — | NCT03979651 Background | Oct 2019 → Jan 2023 | metastatic melanoma | Hospices Civils de Lyon | Completed | No outcome recorded |
| — | NCT04507919 Background | — | small cell lung carcinoma | Novartis Pharmaceuticals | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 50
| Date | Issuer | Release |
|---|---|---|
| 2025-12-10 | Genfit | Results GENFIT: GNS561 Shows Promising Antitumor Activity in Combination Therapy genfit.com ↗
Achieving disease control and tumor reduction in such heavily pretreated patient population with advanced CCA is a significant signal of antitumor activity. |
| 2025-06-12 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Data Across Targeted Protein Degradation Research Including CELMoD™ Agents and BCL6 Ligand-Directed Degrader at EHA 2025 bms.com ↗
80% for mezigdomide plus MEK inhibitor trametinib and dexamethasone (n=20) |
| 2025-02-06 | Genfit | Results GENFIT Outlines Anticipated New Clinical Trial Initiations, Development Milestones and Data Readouts in 2025 genfit.com ↗
Preliminary safety data analyzed end of 2024 from the patients treated in the first cohort of Phase 1b with the combination of GNS561 and trametinib are supportive |
| 2024-10-24 | Erasca, Inc. | Results Erasca Announces Strong Momentum for Naporafenib and RAS Targeting Franchise erasca.com ↗
Positive preliminary Phase 1b SEACRAFT-1 data for naporafenib plus trametinib reinforce therapeutic potential in NRASm melanoma and further support ongoing Phase 3 SEACRAFT-2 trial |
| 2024-05-08 | Erasca, Inc. | Results Erasca Reports First Quarter 2024 Business Updates and Financial Results erasca.com ↗
We started 2024 strong with compelling survival data from a pooled analysis of mature data for naporafenib plus trametinib in patients with NRAS-mutant (NRASm) melanoma, which showed a near doubling of median overall survival (mOS) versus comparable historical controls, |
| 2023-12-11 | Erasca, Inc. | Regulatory Erasca Granted FDA Fast Track Designation for Pan-RAF Inhibitor Naporafenib in Patients with Advanced NRAS-Mutated Melanoma erasca.com ↗
today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to naporafenib in combination with trametinib (MEKINIST®) |
| 2023-04-25 | Erasca, Inc. | Results Erasca Announces Publication of Promising Clinical Data Supporting the Therapeutic Potential of Naporafenib in Combination with Trametinib in NRAS-Mutant Melanoma erasca.com ↗
Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced the publication of results in the Journal of Clinical Oncology from the expansion arm of a Phase 1b open label study evaluating pan-RAF inhibitor naporafenib plus MEK inhibitor trametinib (MEKINIST®) in patients with NRAS-mutant (NRASm) melanoma. |
| 2023-03-17 | Novartis Pharmaceuticals | Regulatory Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma, the most common pediatric brain cancer novartis.com ↗
The FDA also approved liquid formulations of Tafinlar and Mekinist, marking the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for patients as young as one year of age. |
| 2022-06-23 | Novartis Pharmaceuticals | Regulatory Novartis Tafinlar + Mekinist receives FDA approval for first tumor-agnostic indication for BRAF V600E solid tumors novartis.com ↗
Tafinlar + Mekinist, the worldwide targeted therapy leader in BRAF/MEK-inhibition, is the first and only therapy to be approved with a tumor-agnostic indication for adult and pediatric patients with solid tumors that have a BRAF V600E mutation 1 ,2 |
| 2022-06-06 | Novartis Pharmaceuticals | Results Novartis Tafinlar® (dabrafenib) + Mekinist® (trametinib) demonstrates unprecedented efficacy in pediatric patients with BRAF V600 low-grade gliomas in Phase II/III study novartis.com ↗
In this study, patients randomized to receive Tafinlar + Mekinist experienced a statistically significant overall response rate (ORR) of 47% (CI: 35-59%) compared to 11% (CI: 3-25%, p<0.001) for those randomized to receive chemotherapy. |
| 2020-09-19 | Novartis Pharmaceuticals | Results Novartis reports late-breaking data from Phase III COMBI-i trial of spartalizumab (PDR001) with Tafinlar® and Mekinist® in advanced melanoma novartis.com ↗
The efficacy data achieved in the trial’s control arm among patients treated with Tafinlar + Mekinist represent the longest progression-free survival results (PFS) observed across multiple Phase III studies. |
| 2020-09-16 | Novartis Pharmaceuticals | Results Novartis Tafinlar® + Mekinist® demonstrates long-term, relapse-free survival benefit for high-risk, stage III melanoma patients in study published in NEJM novartis.com ↗
The study shows more than half of high-risk patients with resected, stage III BRAF V600-mutated melanoma treated with Tafinlar ® (dabrafenib) + Mekinist ® (trametinib) were alive and relapse-free at 5 years 1 . |
| 2020-08-22 | Novartis Pharmaceuticals | Results Novartis provides update on Phase III study evaluating investigational spartalizumab (PDR001) in combination with Tafinlar® + Mekinist® in advanced melanoma novartis.com ↗
Novartis announced today that the Phase III COMBI-i study evaluating the investigational immunotherapy spartalizumab (PDR001), in combination with the targeted therapies Tafinlar ® (dabrafenib) and Mekinist ® (trametinib), did not meet its primary endpoint of investigator-assessed progression-free survival. |
| 2020-05-29 | Novartis Pharmaceuticals | Results Novartis announces long-term, relapse-free survival benefit for high-risk, stage III melanoma patients treated with Tafinlar® + Mekinist® following surgery novartis.com ↗
Researchers reported that 52% (95% CI, 48%-58%) of patients treated with adjuvant Tafinlar + Mekinist were alive and relapse-free at five years 1 . |
| 2019-06-04 | Novartis Pharmaceuticals | Results Long-term survival benefit shown for metastatic melanoma patients treated with Novartis Tafinlar® + Mekinist® novartis.com ↗
Researchers reported that 34% (95% CI: 30-38%) of all patients in the pooled analysis who were treated with Tafinlar + Mekinist survived at five years[1]. |
| 2018-10-22 | Novartis Pharmaceuticals | Results Novartis COMBI-AD study of Tafinlar® + Mekinist® continues to demonstrate relapse free survival benefit in patients with BRAF V600-mutant stage III melanoma novartis.com ↗
With extended study follow up, Tafinlar in combination with Mekinist continued to show more than 50% risk reduction in relapse free survival (RFS) versus placebo in patients with resected BRAF V600-mutant stage III melanoma. |
| 2018-08-29 | Novartis Pharmaceuticals | Regulatory European Commission approves Novartis combination therapy Tafinlar® + Mekinist® for adjuvant treatment of BRAF V600 mutation-positive melanoma novartis.com ↗
Novartis announced today that the European Commission (EC) has approved Tafinlar ® (dabrafenib) in combination with Mekinist ® (trametinib) for the adjuvant treatment of stage III patients with BRAF V600 mutation-positive melanoma after complete surgical resection. |
| 2018-07-27 | Novartis Pharmaceuticals | Regulatory Novartis combination Tafinlar® + Mekinist® receives positive CHMP opinion for adjuvant treatment of BRAF V600 mutation-positive melanoma novartis.com ↗ |
| 2018-04-30 | Novartis Pharmaceuticals | Regulatory Novartis receives FDA approval of Tafinlar® + Mekinist® for adjuvant treatment of BRAF V600-mutant melanoma novartis.com ↗ |
| 2017-12-22 | Novartis Pharmaceuticals | Regulatory Novartis' combination therapy Tafinlar® + Mekinist® granted FDA Priority Review for the adjuvant treatment of stage III BRAF V600 mutation-positive melanoma novartis.com ↗ |
| 2017-10-23 | Novartis Pharmaceuticals | Regulatory Novartis combination adjuvant therapy Tafinlar® + Mekinist® receives FDA Breakthrough Therapy Designation for stage III BRAF V600 mutation-positive melanoma patients novartis.com ↗ |
| 2017-09-11 | Novartis Pharmaceuticals | Results Novartis Phase III study demonstrates adjuvant Tafinlar® + Mekinist® reduced the risk of disease recurrence by 53% in patients with resected BRAF V600 mutation-positive melanoma novartis.com ↗ |
| 2017-06-22 | Novartis Pharmaceuticals | Regulatory Novartis combination targeted therapy Tafinlar® + Mekinist® receives FDA approval for BRAF V600E mutant metastatic non-small cell lung cancer (NSCLC) novartis.com ↗
Basel, June 22, 2017 - Novartis today announced the US Food and Drug Administration (FDA) approval of Tafinlar ® (dabrafenib) in combination with Mekinist ® (trametinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express the BRAF V600E mutation. |
| 2017-06-04 | Novartis Pharmaceuticals | Results Novartis landmark study of Tafinlar® + Mekinist® demonstrates durable survival benefit at five years in patients with BRAF mutation-positive metastatic melanoma novartis.com ↗
Basel, June 4, 2017 - Novartis today announced results from a Phase II study showing a durable survival benefit for some patients with BRAF V600 mutation-positive metastatic melanoma (MM) when treated with the combination of Tafinlar ® (dabrafenib) + Mekinist ® (trametinib)[1]. |
| 2017-04-03 | Novartis Pharmaceuticals | Regulatory Novartis drug combination Tafinlar® + Mekinist® receives EU approval for BRAF V600-positive advanced non-small cell lung cancer (NSCLC) novartis.com ↗
Basel, April 3, 2017 - Novartis today announced the European Commission has approved Tafinlar ® (dabrafenib) in combination with Mekinist ® (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC). |
| 2017-02-24 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for Tafinlar® + Mekinist® in BRAF-positive non-small cell lung cancer (NSCLC) patients novartis.com ↗
Novartis today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) to treat patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express the BRAF V600 mutation. |
| 2016-10-08 | Novartis Pharmaceuticals | Results Novartis' Tafinlar® (dabrafenib) + Mekinist® (trametinib) demonstrate superior overall survival benefit in advanced melanoma patients at three-year follow up novartis.com ↗
Results from the COMBI-v study found the estimated three-year survival rate to be 45% of patients receiving the combination of Tafinlar + Mekinist (95% CI, 39.1%-49.8%) compared with 31% of patients who received vemurafenib monotherapy (95% CI, 26.1%-36.4%)[1]. |
| 2016-06-06 | Novartis Pharmaceuticals | Results Novartis pivotal data for Tafinlar® + Mekinist® demonstrated a 63 percent overall response rate in treating rare form of lung cancer novartis.com ↗
In the study, patients treated with Tafinlar + Mekinist demonstrated an overall response rate (ORR) of 63% (95% CI, 49%-76%)[1]. |
| 2016-06-06 | Novartis Pharmaceuticals | Results Novartis combination therapy Tafinlar® + Mekinist® demonstrates overall survival benefit at three-year follow-up in patients with advanced melanoma novartis.com ↗
Novartis today announced data from a Phase III study showing a significant survival benefit for patients with BRAF V600E/K mutation-positive advanced melanoma when treated with the first-line combination of Tafinlar ® (dabrafenib) + Mekinist ® (trametinib) compared to Tafinlar monotherapy[1]. |
| 2016-06-05 | Merck Sharp & Dohme LLC | Results New Data for KEYTRUDA® (pembrolizumab) in Combination with Talimogene Laherparepvec, Dabrafenib Plus Trametinib, or Low-Dose Ipilimumab in Advanced Melanoma Presented at 2016 ASCO Annual Meeting merck.com ↗
today announced findings from three separate studies evaluating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in combination with other treatment regimens including talimogene laherparepvec, dabrafenib plus trametinib, or low-dose ipilimumab in patients with advanced melanoma. |
| 2015-09-28 | Novartis Pharmaceuticals | Results Patients with aggressive form of melanoma lived for more than two years on average when taking Novartis therapies Tafinlar® + Mekinist® novartis.com ↗
Novartis today announced updated data from the Phase III COMBI-v study showing a significant overall survival benefit for patients with BRAF V600E/K mutation-positive metastatic melanoma when treated with the combination of Tafinlar ® (dabrafenib) + Mekinist ® (trametinib) compared to vemurafenib monotherapy. |
| 2015-09-01 | Novartis Pharmaceuticals | Regulatory Novartis receives EU approval for Tafinlar® and Mekinist®, first combination approved for patients with aggressive form of melanoma novartis.com ↗
Novartis today announced that the European Commission has approved the combination of Tafinlar ® (dabrafenib) and Mekinist ® (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
| 2015-07-24 | Novartis Pharmaceuticals | Regulatory Novartis combination therapy Tafinlar® and Mekinist® achieves important EU and US regulatory milestones novartis.com ↗
The Company also announced that the US Food and Drug Administration (FDA) has granted priority review for the same patient population. |
| 2015-06-01 | Novartis Pharmaceuticals | Results Novartis presents new data at ASCO for Zykadia® and combination of Tafinlar® and Mekinist® in certain NSCLC patients with unmet needs novartis.com ↗
Separately, the study of dabrafenib in combination with trametinib in patients with metastatic BRAF V600E-mutation positive NSCLC who had failed at least one round of chemotherapy demonstrated an ORR of 63% in this population[3]. |
| 2015-05-31 | Novartis Pharmaceuticals | Results Combination of Novartis drugs Tafinlar® and Mekinist® shows significant survival benefit in patients with metastatic melanoma novartis.com ↗ |
| 2015-05-30 | AstraZeneca | Results AstraZeneca and MedImmune present positive immuno-oncology combination data at the 2015 ASCO Annual Meeting astrazeneca.com ↗
Preliminary results from the first ever Phase I triple combination study of MEDI4736 with BRAF (dabrafenib) and/or MEK (trametinib) 1 inhibitors in patients with advanced melanoma showed clinical activity with acceptable tolerability, with all three agents at full doses. |
| 2015-02-06 | GlaxoSmithKline | Results GSK announces positive overall survival results from phase III COMBI-d study of dabrafenib (Tafinlar™) and trametinib (Mekinist™) combination gsk.com ↗
The safety profile was consistent with the profile observed to date for the combination; no new safety concerns were observed. |
| 2014-11-16 | GlaxoSmithKline | Results New England Journal of Medicine publishes positive results from COMBI-v study of trametinib (Mekinist™) and dabrafenib (Tafinlar™) combination gsk.com ↗
Treatment with the combination increased median progression-free survival to 11.4 months compared to 7.3 months for the vemurafenib arm. |
| 2014-07-17 | GlaxoSmithKline | Results Trametinib (Mekinist™) and dabrafenib (Tafinlar™) combination demonstrated overall survival benefit compared to vemurafenib; phase III BRAF V600-mutant metastatic melanoma study stopped early gsk.com ↗
This IDMC recommendation is based on an interim analysis which demonstrated an overall survival benefit for the trametinib and dabrafenib combination compared to vemurafenib that crossed the pre-specified efficacy stopping boundary. |
| 2014-07-04 | GlaxoSmithKline | Regulatory GSK receives EU marketing authorisation for Mekinist™ (trametinib) for patients with unresectable or metastatic melanoma with a BRAF V600 mutation gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the European Commission (EC) has granted marketing authorisation for Mekinist™ (trametinib) as a single agent in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
| 2014-04-25 | GlaxoSmithKline | Regulatory GSK receives positive CHMP opinion for Mekinist™ (trametinib) in metastatic melanoma with a BRAF V600 mutation gsk.com ↗
Issued: London UK GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Mekinist™(trametinib) as a single agent in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
| 2014-03-26 | GlaxoSmithKline | Regulatory Regulatory update: combined use of Mekinist™ (trametinib) and Tafinlar® (dabrafenib) in Europe gsk.com ↗
today announced that it has withdrawn its Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for the use of Mekinist (trametinib) in combination with the previously approved BRAF inhibitor Tafinlar (dabrafenib) |
| 2014-01-24 | GlaxoSmithKline | Results GSK announces headline results for Phase III study of the combination of Tafinlar® (dabrafenib) and Mekinist® (trametinib) in metastatic melanoma gsk.com ↗
We are pleased to report that the first of our phase III studies investigating the combination of Tafinlar and Mekinist met its primary endpoint. |
| 2014-01-09 | GlaxoSmithKline | Regulatory GSK gains accelerated FDA approval for combination use of Mekinist® (trametinib) and Tafinlar® (dabrafenib) gsk.com ↗
The combination was approved through the FDA’s Accelerated Approval programme and reviewed under a Priority Review designation. |
| 2013-09-16 | GlaxoSmithKline | Regulatory GSK receives Priority Review from FDA for dabrafenib/trametinib combination in metastatic melanoma gsk.com ↗
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of 8 January 2014 for the Mekinist® (trametinib) supplement and 9 January 2014 for the Tafinlar® (dabrafenib) supplement. |
| 2013-07-09 | GlaxoSmithKline | Regulatory Regulatory update – GSK announces US submission for dabrafenib/trametinib combination in metastatic melanoma gsk.com ↗
GlaxoSmithKline (GSK) plc today announced submission of supplemental New Drug Applications (NDAs) to the US Food and Drug Administration for use of dabrafenib, a BRAF inhibitor, in combination with trametinib, a MEK inhibitor. |
| 2013-05-29 | GlaxoSmithKline | Regulatory Two new GSK oral oncology treatments, BRAF-inhibitor Tafinlar® (dabrafenib) capsules and the first MEK-inhibitor Mekinist™ (trametinib) tablets, approved by FDA as single-agent therapies gsk.com ↗
GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved both TAFINLAR® (dabrafenib) and MEKINIST™ (trametinib). |
| 2013-05-01 | GlaxoSmithKline | Regulatory Regulatory update: Trametinib US PDUFA date extended to 3 September 2013 gsk.com ↗
GSK today announced that the US Prescription Drug User Fee Act (PDUFA) goal date for trametinib, its MEK inhibitor, has been extended by 3 months to 3 September 2013. |
| 2013-02-07 | GlaxoSmithKline | Regulatory Regulatory update – GSK announces European submission for MEK monotherapy and BRAF/MEK combination therapy in metastatic melanoma gsk.com ↗
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted GSK’s request for accelerated assessment of this application. |
| 2012-08-03 | GlaxoSmithKline | Regulatory Regulatory update – GSK announces submissions in the EU and US for dabrafenib and trametinib gsk.com ↗
A New Drug Application to the US Food and Drug Administration for trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutations as detected by an FDA-approved test. |
All press releases naming this drug 56 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 271 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trametinib | “Managed Access Program Cohort Treatment Plan CTMT212X2002I to Provide Access to Trametinib and Dabrafenib Combination Therapy for Patients With BRAF V600 Mutation-positive...” NCT04507919 ↗245“we randomly assigned 322 patients who had metastatic melanoma with a V600E or V600K BRAF mutation to receive either trametinib, an oral selective MEK inhibitor, or chemotherapy...” PMID 22663011 ↗ Jun 2012 “Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and...” NCT01553851 ↗ “Phase II study of the MEK1/MEK2 inhibitor Trametinib in patients with metastatic BRAF-mutant cutaneous melanoma previously treated with or without a BRAF inhibitor.” PMID 23248257 ↗ Dec 2012 “Axitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib” NCT07802418 ↗ “A phase IB trial of the oral MEK inhibitor trametinib (GSK1120212) in combination with everolimus in patients with advanced solid tumors.” PMID 25344362 ↗ Oct 2014 “For example, Trametinib is used as follows: Trametinib will be administered daily from Cycle 5 until the end of induction chemotherapy.” NCT06933394 ↗ “A Study to Determine the Relative Bioavailability of the MEK Inhibitor, Trametinib, in Subjects With Solid Tumor Malignancies” NCT01725100 ↗ “Approved BRAF-/MEK- inhibitor combinations include dabrafenib/trametinib and encorafenib/binimetinib.” NCT05370807 ↗ “Dabrafenib 150 mg twice a day combined with Trametinib 2 mg once a day for 4 weeks” NCT04644432 ↗ “A randomized phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212)” PMID 25722381 ↗ Feb 2015 |
| Known as | GSK1120212 | “This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma...” NCT02039947 ↗30“The purpose of this study was to determine the response rate (RR) for the selective, allosteric MEK1/MEK2 inhibitor trametinib (GSK1120212), in patients with metastatic...” PMID 23248257 ↗ Dec 2012 “This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.” NCT01597908 ↗ “Each tablet contains GSK1120212B equivalent to 2 mg of GSK1120212 as drug substance.” NCT01725100 ↗ “A phase I/Ib study of trametinib (GSK1120212) alone and in combination with” PMID 26259955 ↗ Aug 2015 “Trametinib (GSK1120212)” NCT01941927 ↗ “Trametinib (GSK1120212)” NCT01192165 ↗ |
| Known as | GSK1120212B | “Each tablet will contain GSK1120212B equivalent to 0.5 mg of Trametinib.” NCT02292732 ↗ |
| Known as | MEK Inhibitor Trametinib GSK1120212 | “MEK Inhibitor Trametinib GSK1120212” NCT01726738 ↗ |
| Known as | Mekinist | “On March 16, 2023, the FDA approved dabrafenib in combination with trametinib (Tafinlar, Mekinist; Novartis Pharmaceuticals Corporation) for the treatment of pediatric patients...” PMID 37610803 ↗ Jan 20245“The main purpose of this study is to determine the risks and benefits of ceritinib (ZYKADIA) given in combination with trametinib (MEKINIST) in patients who have progressed on...” NCT03501368 ↗ “Mekinist© (Trametinib) taken orally each day with a 18-course schedule of 4 weeks each.” NCT05180825 ↗ “Study drugs are Dabrafenib (Tafinlar) and trametinib (Mekinist)” NCT05525273 ↗ “Trametinib 2 MG [Mekinist]” NCT04619316 ↗ “Trametinib (Mekinist)” NCT03149029 ↗ |
| Known as | MEKINISTR | “Trametinib (MEKINISTR) is an orally available MEK inhibitor that is currently approved in combination with the BRAF inhibitor dabrafenib (TAFINLARR) to treat BRAF mutated...” NCT03979651 ↗ |
| Known as | TMT212 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02900664 ↗ |
| Known as | Trametinib Dimethyl Sulfoxide | “I. To identify a maximum tolerated dose for the EZH2 inhibitor, tazemetostat hydrobromide (tazemetostat), when used in combination with dual BRAF inhibitor (dabrafenib mesylate...” NCT04557956 ↗4“Drug: Trametinib Dimethyl Sulfoxide” NCT03794297 ↗ “Drug: Trametinib Dimethyl Sulfoxide” NCT04439357 ↗ “Drug: Trametinib Dimethyl Sulfoxide” NCT04439279 ↗ “Drug: Trametinib Dimethyl Sulfoxide” NCT02196181 ↗ |
| Action | Inhibit | “the MEK Inhibitor GSK1120212” NCT00687622 ↗ |
| Modality | Small molecule | “Investigational small molecule targeted therapy (MEK1/2 inhibitor)” NCT01192165 ↗ |
| Route | Oral | “orally administered GSK1120212” NCT00687622 ↗ |
| Target | MEK1 | “Trametinib: Therapeutic class Protein kinase inhibitor of MEK1 and MEK2 activation and kinase activity.” NCT03714958 ↗ |
| Target | MEK2 | “Trametinib: Therapeutic class Protein kinase inhibitor of MEK1 and MEK2 activation and kinase activity.” NCT03714958 ↗ |