Drugs / Dabrafenib
Dabrafenib
also known as
GSK2118436 · Dabrafenib Mesylate · Tafinlar · GSK2118436B · BRAF Inhibitor Dabrafenib GSK2118436 · Dabrafenib mesilate · Finlee · GSK-2118436 METHANESULFONATE SALT · +5 more
Small molecule targets BRAF via inhibition
Regulatory milestones approvals, filings & regulatory actions · 17 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed melanomatosis 1 milestone | |||||
| Filed | EU (EMA) | — | melanomatosis | 2013-02-07 | “today announced submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) for trametinib (MEK) as monotherapy and in combination with dabrafenib (BRAF)” gsk.com ↗ |
| Filed metastatic melanoma 2 milestones | |||||
| Filed | EU (EMA) | Tafinlar/Mekinist | metastatic melanoma | 2015-07-21 | “Tafinlar/Mekinist: demandes d'homologation déposées en Europe et au Japon pour le mélanome métastatique” novartis.com ↗ “submissions were completed in the EU and Japan for first line melanoma in the second quarter of 2015.” 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 | 2015-07-21 | “Tafinlar/Mekinist: demandes d'homologation déposées en Europe et au Japon pour le mélanome métastatique” novartis.com ↗ “submissions were completed in the EU and Japan for first line melanoma in the second quarter of 2015.” 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) | Tafinlar + Mekinist | non-small cell lung carcinoma | 2016-10-25 | “Tafinlar + Mekinist (dabrafenib + trametinib) combination therapy was filed with the EMA” novartis.com ↗ |
| Filed | Other | Tafinlar + Mekinist | 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 expansions (10) | US (FDA) | TAFINLAR | — | 2014-01-09 – 2025-03-07 | fda.gov ↗ |
| Approved | EU (EMA) | Tafinlar | — | 2013-08-26 | europa.eu ↗ |
| Approved | US (FDA) | TAFINLAR | — | 2013-05-29 | fda.gov ↗ |
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EU approved 2013
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 134 trials | ||||||
| Phase 1 | NCT05388877 | Oct 2022 → Nov 2024 | cutaneous melanoma, metastatic malignant neoplasm in the brain, metastatic melanoma | Mayo Clinic | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04903119 | Jun 2022 → Jul 2028 expected | metastatic melanoma | Rina Plattner | 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 | NCT04418167 | Jun 2020 → Dec 2025 | cancer | JS InnoPharm, LLC | Suspended | 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 | NCT03272464 | May → Jul 2019 | melanoma | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03332589 | Jul 2018 → Apr 2021 | melanoma, metastatic malignant neoplasm in the brain | Spirita Oncology, LLC | Terminated | No outcome recorded |
| 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 | NCT02447939 | May 2017 → Oct 2018 | melanoma | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT02873650 | Dec 2016 → Oct 2018 | — | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02852239 | Dec 2016 → Sep 2019 | impaired renal function disease | 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 | NCT02357732 | Aug 2015 | metastatic melanoma | University of Pittsburgh | Withdrawn | No outcome recorded |
| Phase 1 | NCT02082665 | Feb 2015 → Jul 2016 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02110355 | Dec 2014 → Dec 2018 | cancer, melanoma | Kartos Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02200562 | Dec 2014 → Jan 2017 | melanoma | University of Utah | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02097225 | May 2014 → Mar 2019 | cutaneous melanoma, metastatic malignant neoplasm, metastatic melanoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT02027961 | Dec 2013 → Apr 2018 | melanoma | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT01954043 | Dec 2013 → Feb 2016 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01947023 | Sep 2013 → Apr 2026 overdue | thyroid gland carcinoma | National Cancer Institute (NCI) | Active not recruiting | 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 | NCT01907802 | Aug 2013 → Dec 2015 | kidney failure, liver disorder, neoplasm | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT01767454 | Feb 2013 → Sep 2015 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01738451 | Jan 2013 → Nov 2014 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01713972 | Nov 2012 → Jul 2016 | cancer of unknown primary site | Manisha Shah | Completed | No outcome recorded |
| Phase 1 | NCT01340846 | Sep → Nov 2012 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01582997 | May 2012 → Aug 2014 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01340833 | Jun → Sep 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01262963 | Jan → Apr 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01231594 | Nov 2010 → Apr 2018 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01231568 | Oct 2010 → May 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00880321 | Jun 2009 → Mar 2011 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/215 trials · 1 met primary · 1 missed | ||||||
| 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 | NCT04557956 | Aug 2021 → Oct 2025 overdue | cutaneous melanoma, metastatic melanoma | National Cancer Institute (NCI) | Active not recruiting | 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 | NCT03455764 | Sep 2018 → Sep 2023 | melanoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT03754179 | Jan 2018 → Dec 2021 | melanoma | University Hospital Brussels | Unknown | No outcome recorded |
| Phase 1/2 | NCT03391050 | Jan → Aug 2018 | melanoma | Aprea Therapeutics | Terminated | No outcome recorded |
| 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 | 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 | 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 | NCT01677741 | May 2013 → Dec 2020 | brain neoplasm | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT01750918 | Dec 2012 → Jun 2020 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 276 trials · 6 met primary · 2 missed | ||||||
| Phase 2 | NCT07714447 | Nov 2026 → Feb 2029 expected | colorectal cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07802418 | Oct 2026 → Jun 2031 expected | malignant pancreatic neoplasm | Herlev Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07506109 | Mar 2026 → Dec 2027 expected | colorectal cancer | Tianjin Medical University Cancer Institute and Hospital | 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 | NCT07022834 | Jun 2025 → Jun 2028 expected | Langerhans cell histiocytosis | West China Second University Hospital | 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 | NCT06978400 | Mar 2025 → Nov 2027 expected | neoplasm | Blokhin's Russian Cancer Research Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06739395 | Nov 2024 → Dec 2026 expected | cancer | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06563999 | Nov 2024 → Nov 2027 expected | lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06362694 | Mar 2024 → Mar 2026 | thyroid gland undifferentiated (anaplastic) carcinoma | Saint Petersburg State University, Russia | Unknown | No outcome recorded |
| Phase 2 | NCT06054191 | Feb 2024 → Mar 2025 overdue | non-small cell lung carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05525273 | Sep 2023 → Sep 2027 expected | craniopharyngioma | Eva Marie Erfurth, MD, PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT05876806 | Jun 2023 → Mar 2026 | cancer | Se Jun Park | Unknown | No outcome recorded |
| Phase 2 | NCT06079333 | Jan 2023 → Jan 2027 expected | thyroid gland undifferentiated (anaplastic) carcinoma | Leiden University Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06653517 | Jan 2023 → Dec 2026 expected | ameloblastoma | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Recruiting | No outcome recorded |
| Phase 2 | NCT05182931 | Jul 2022 → Dec 2024 | thyroid cancer | Olivia Newton-John Cancer Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT05159245 | Dec 2021 → Nov 2026 expected | cancer, hematopoietic and lymphoid cell neoplasm | Helsinki University Central Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04675710 | Jun 2021 → Oct 2028 expected | thyroid gland squamous cell carcinoma, thyroid gland undifferentiated (anaplastic) carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06482086 | Jun 2021 → Dec 2024 overdue | thyroid gland carcinoma | West China Hospital | Recruiting | Met primary |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05299580 | Feb 2021 → Mar 2023 | melanoma | Fondazione Melanoma Onlus | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04739566 | Jan 2021 → Dec 2023 | thyroid gland undifferentiated (anaplastic) carcinoma | Saint Petersburg State University, Russia | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04554680 | Dec 2020 → Dec 2021 | thyroid cancer | National University Hospital, Singapore | Unknown | No outcome recorded |
| Phase 2 | NCT04544111 | Sep 2020 → Sep 2027 expected | poorly differentiated thyroid gland carcinoma, thyroid gland follicular carcinoma, thyroid gland papillary carcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04452877 | Aug 2020 → Nov 2024 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04644432 | Mar 2020 → Sep 2022 | renal cell carcinoma | Herlev and Gentofte Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03919071 | Feb 2020 → Sep 2027 expected | anaplastic astrocytoma, anaplastic ganglioglioma, anaplastic pleomorphic xanthoastrocytoma, glioblastoma +1 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04310397 | Jan 2020 → Oct 2023 | cutaneous melanoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04116541 | Jan 2020 → Oct 2026 expected | cancer | Centre Leon Berard | Recruiting | No outcome recorded |
| Phase 2 | NCT03972046 | Jun 2019 → Feb 2020 | cutaneous melanoma, metastatic melanoma | TriHealth Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT04059224 | Jan 2019 → Jun 2023 | melanoma | University Hospital Brussels | Completed | No outcome recorded |
| Phase 2 | NCT03794297 | Jan 2019 → Feb 2021 | Erdheim-Chester disease | National Cancer Institute (NCI) | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03668431 | Oct 2018 → Sep 2022 | colorectal cancer | Massachusetts General Hospital | Unknown | Met primary |
| Phase 2 | NCT02672358 | Sep 2018 → Sep 2019 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT03543306 | Jun 2018 → Jun 2020 | lung cancer | Asan Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT03563729 | Jun 2018 → Jun 2024 overdue | melanoma | Inge Marie Svane | Recruiting | No outcome recorded |
| Phase 2 | NCT02974803 | Feb 2018 → Jul 2020 | melanoma, metastatic malignant neoplasm in the brain | Canadian Cancer Trials Group | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04619316 | Feb 2018 → Dec 2024 | thyroid cancer | University Hospital, Essen | Unknown | No outcome recorded |
| Phase 2 | NCT02684058 | Dec 2017 → Aug 2021 | Lhermitte-Duclos disease, anaplastic astrocytoma, anaplastic ganglioglioma, anaplastic oligodendroglioma +15 | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT03244956 | Dec 2017 → May 2022 | cancer, familial, with in vitro Radioresistance | Gustave Roussy, Cancer Campus, Grand Paris | Completed | No outcome recorded |
| Phase 2 | NCT03149029 | Nov 2017 → Dec 2021 overdue | metastatic melanoma | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02858921 | Nov 2017 → Jan 2022 | melanoma | Melanoma Institute Australia | Unknown | Met primary |
| Phase 2 | NCT03352947 | Nov 2017 → Mar 2020 | melanoma | Cambridge University Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT02367859 | Jul 2017 → Nov 2018 | ameloblastoma | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT03239015 | Jan 2017 → Jun 2023 | refractory malignant neoplasm | Baodong Qin | Unknown | No outcome recorded |
| Phase 2 | NCT02910700 | Dec 2016 → Dec 2027 expected | cutaneous melanoma, metastatic malignant neoplasm in the brain, metastatic melanoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | Mixed |
| Phase 2 | NCT02693535 | Mar 2016 → Dec 2027 expected | non-Hodgkin lymphoma, plasma cell myeloma | American Society of Clinical Oncology | Recruiting | Mixed |
| Phase 2 | NCT04439292 | Jan 2016 → Nov 2023 overdue | adult lymphoma, plasma cell myeloma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02625337 | Jan 2016 → Jun 2018 | metastatic melanoma | The Netherlands Cancer Institute | Unknown | No outcome recorded |
| Phase 2 | NCT02410863 | Nov 2015 → Aug 2018 | melanoma | Prof. Dr. med. Dirk Schadendorf | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2027 expected | breast carcinoma, carcinoma of esophagus, cervical carcinoma, colon carcinoma +17 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02281760 | Nov 2014 → Aug 2018 | — | National Human Genome Research Institute (NHGRI) | Completed | No outcome recorded |
| Phase 2 | NCT02231775 | Oct 2014 → Apr 2027 expected | cutaneous melanoma | M.D. Anderson Cancer Center | Active not recruiting | Met primary |
| Phase 2 | NCT01972347 | Oct 2014 → May 2017 | melanoma | Melanoma Institute Australia | Completed | No outcome recorded |
| Phase 2 | NCT02296996 | Oct 2014 → Dec 2017 | melanoma | University Hospital Brussels | Completed | No outcome recorded |
| Phase 2 | NCT02196181 | Sep 2014 → Mar 2027 expected | cutaneous melanoma | National Cancer Institute (NCI) | Active not recruiting | Missed primary |
| Phase 2 | NCT02142036 | May 2014 → Aug 2018 | metastatic malignant neoplasm | Oslo University Hospital | Completed | Met primary |
| Phase 2 | NCT01978236 | Apr 2014 → Apr 2017 | metastatic melanoma | GlaxoSmithKline | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02083354 | Mar 2014 → Feb 2018 | cancer, melanoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02034110 | Mar 2014 → Dec 2021 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02039947 | Feb 2014 → May 2017 | metastatic melanoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02052193 | Jan → Dec 2014 | metastatic melanoma | University Hospital Tuebingen | Terminated | No outcome recorded |
| Phase 2 | NCT02314143 | Nov 2013 → Jan 2017 | melanoma | GlaxoSmithKline | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01928940 | Aug 2013 → Sep 2014 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01726738 | Apr 2013 → Nov 2017 | melanoma | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01721603 | Apr 2013 → Jan 2016 | — | University of California, San Francisco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01701037 | Jan 2013 → Feb 2015 | melanoma | Vanderbilt-Ingram Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01723202 | Nov 2012 → Apr 2022 | poorly differentiated thyroid gland carcinoma, thyroid gland follicular carcinoma, thyroid gland papillary carcinoma | Bhavana Konda | Completed | Missed primary |
| Phase 2 | NCT01682213 | Sep 2012 → May 2019 | melanoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01619774 | Sep 2012 → Aug 2015 | melanoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01336634 | Aug 2011 → Oct 2015 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01266967 | Feb → Nov 2011 | metastatic melanoma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01153763 | Aug 2010 → Jul 2011 | melanoma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01072175 | Mar 2010 → May 2012 | cancer | Novartis Pharmaceuticals | Completed | Mixed |
| Phase 2/33 trials | ||||||
| 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 39 trials · 7 met primary | ||||||
| Phase 3 | NCT06264778 | Mar 2024 → Nov 2025 | ameloblastoma | Shandong University | Unknown | 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 | NCT02224781 | Sep 2015 → Sep 2023 overdue | cutaneous melanoma, metastatic melanoma | National Cancer Institute (NCI) | Active not recruiting | 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 | NCT01227889 | Dec 2010 → Dec 2011 | cancer | 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 applicable4 trials | ||||||
| — | NCT05963087 | Aug 2023 → Feb 2025 | colorectal cancer | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| — | NCT01534897 | Jul 2012 → Mar 2014 | thyroid gland papillary carcinoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT04544202 | — | melanoma | Novartis Pharmaceuticals | No longer available | No outcome recorded |
| — | NCT04489433 | — | melanoma | Novartis Pharmaceuticals | No longer available | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT03026517 Background | Jan 2017 → Jan 2025 | melanoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT05585320 Background | Oct 2022 → Jun 2026 overdue | cutaneous melanoma, non-small cell lung carcinoma, pancreatic adenocarcinoma | Immuneering Corporation | Active not recruiting | 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 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 |
| — | NCT04507919 Background | — | small cell lung carcinoma | Novartis Pharmaceuticals | No longer available | No outcome recorded |
| — | NCT02416232 Background | — | cutaneous melanoma | GlaxoSmithKline | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 45
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
In patients with advanced BRAF-mutation positive melanoma, confirmed partial responses were seen in 69% of patients (18/26) receiving MEDI4736 plus dabrafenib and trametinib. |
| 2015-04-23 | Novartis Pharmaceuticals | Results Novartis delivered sales growth (cc), significant margin expansion (cc) and strong innovation in Q1[1]; now with a more focused portfolio novartis.com ↗
Overall survival results from the COMBI-d study demonstrated a statistically significant reduction in the risk of death for the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) compared to dabrafenib monotherapy in patients with BRAF V600E/K mutation-positive metastatic melanoma. |
| 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. |
| 2014-09-29 | GlaxoSmithKline | Results GSK announces overall survival results from phase III BREAK-3 study of Tafinlar® (dabrafenib) in patients with BRAF V600E-mutant metastatic melanoma gsk.com ↗
GSK today announced updated results for Tafinlar® (dabrafenib) from a planned analysis of the phase III BREAK-3 study in 250 patients with BRAF V600E mutant metastatic melanoma. |
| 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. |
| 2014-03-26 | 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. |
| 2014-01-13 | GlaxoSmithKline | Regulatory Tafinlar® receives FDA Breakthrough Therapy designation for non-small cell lung cancer with BRAF mutation gsk.com ↗ |
| 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. |
| 2013-09-02 | GlaxoSmithKline | Regulatory GSK receives marketing authorisation from the European Commission for Tafinlar™ gsk.com ↗
GlaxoSmithKline plc announced today that the European Commission has granted marketing authorisation for Tafinlar™ (dabrafenib) as an oral targeted treatment indicated in monotherapy for unresectable melanoma |
| 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. |
| 2013-06-28 | GlaxoSmithKline | Regulatory Regulatory Update - GSK receives positive CHMP opinions for Tafinlar® (dabrafenib) and Tyverb® (lapatinib) gsk.com ↗
CHMP issued positive opinions for: · Tafinlar® (dabrafenib) as treatment for adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
| 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). |
| 2013-02-07 | 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 Marketing Authorisation Application to the European Medicines Agency for dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
All press releases naming this drug 46 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 159 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dabrafenib | “Axitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib” NCT07802418 ↗142“Dabrafenib is a small-molecule inhibitor of BRAF kinase activity that is currently being developed for the treatment of BRAF V600 mutation-positive melanoma.” PMID 23608920 ↗ Apr 2013 “BRAF inhibitors (encorafenib, vemurafenib, dabrafenib, etc.) are selected by researchers from the available drugs based on their accessibility” NCT07714447 ↗ “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 ↗ “Dabrafenib 150 mg twice daily and trametinib 2 mg once daily” NCT03543306 ↗ “Cytarabine HCl Dabrafenib Dasatinib” NCT02551718 ↗ “Dabrafenib + trametinib” NCT04817956 ↗ “Drug: Dabrafenib” NCT03754179 ↗ “Dabrafenib” NCT02142036 ↗ |
| Known as | BRAF Inhibitor Dabrafenib GSK2118436 | “BRAF Inhibitor Dabrafenib GSK2118436” NCT01726738 ↗ |
| Known as | Dabrafenib mesilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028663 ↗ |
| Known as | Dabrafenib Mesylate | “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“Generic name: Dabrafenib mesylate capsules” NCT06264778 ↗ “Drug: Dabrafenib Mesylate” NCT02196181 ↗ “Drug: Dabrafenib Mesylate” NCT03794297 ↗ |
| Known as | Finlee | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028663 ↗ |
| Known as | GSK-2118436 METHANESULFONATE SALT | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028663 ↗ |
| Known as | GSK-2118436A | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028663 ↗ |
| Known as | GSK-2118436B MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028663 ↗ |
| Known as | GSK-2118436B METHANESULFONATE SALT | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028663 ↗ |
| Known as | GSK2118436 | “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 ↗17“This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.” NCT01597908 ↗ “Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation” NCT01682213 ↗ “An Open-label Phase 1 Study to Evaluate the Effects of Dabrafenib (GSK2118436) on the Single Dose Pharmacokinetics” NCT02082665 ↗ “Repeat Dose Pharmacokinetics of Dabrafenib (GSK2118436)” NCT01954043 ↗ |
| Known as | GSK2118436B | “A Phase 1 and Pharmacokinetic Study of Dabrafenib (GSK2118436B) in Patients With BRAFV600X Mutations and Renal or Hepatic Dysfunction” NCT01907802 ↗1“Dabrafenib mesylate (GSK2118436B) is a potent and selective BRAF kinase inhibitor.” NCT02281760 ↗ |
| Known as | METHANE SULFONATE SALT | ChEMBL registry synonym — accepted as the source's own label CHEMBL2028663 ↗ |
| Known as | mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06978400 ↗ |
| Known as | Tafinlar | “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 20243“Trametinib 2 MG [Mekinist] and Dabrafenib 75 MG (2-0-2) [Tafinlar]” NCT04619316 ↗ “Study drugs are Dabrafenib (Tafinlar) and trametinib (Mekinist)” NCT05525273 ↗ “Dabrafenib (Tafinlar)” NCT03149029 ↗ |
| Action | Inhibit | “BRAF inhibitor” NCT00880321 ↗ |
| Modality | Small molecule | “Dabrafenib is a small-molecule inhibitor of BRAF kinase activity” PMID 23608920 ↗ Apr 2013 |
| Route | Oral | “orally administered GSK2118436” NCT00880321 ↗ |
| Target | BRAF | “BRAF inhibitor” NCT00880321 ↗ |