Drugs / Encorafenib
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (8) | US (FDA) | BRAFTOVI | — | 2019-01-23 – 2026-02-24 | fda.gov ↗ |
| Approved | EU (EMA) | Braftovi | — | 2018-09-19 | europa.eu ↗ |
| Approved | US (FDA) | BRAFTOVI | — | 2018-06-27 | fda.gov ↗ |
Trials 83 · started per year
today
US approved 2018
EU approved 2018
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04741997 | May 2021 → Jul 2026 overdue | metastatic melanoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 0 | NCT03543969 | Jun 2018 → Dec 2024 overdue | cutaneous melanoma, skin carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 113 trials | ||||||
| Phase 1 | NCT06102902 | Jun 2024 → Jan 2027 | colorectal adenocarcinoma | National Cancer Institute (NCI) | Suspended | No outcome recorded |
| Phase 1 | NCT05985954 | Jan 2024 → Mar 2028 expected | colorectal cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05743036 | Feb 2023 → Jul 2024 | colorectal cancer | K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 1 | NCT05446142 | Jul → Sep 2022 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05003622 | Sep 2021 → May 2022 | melanoma | Pierre Fabre Laboratories | Completed | No outcome recorded |
| Phase 1 | NCT04800822 | Mar 2021 → Jun 2024 | neoplasm | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT04759846 | Jan 2021 → May 2023 | metastatic melanoma | Pierre Fabre Laboratories | Withdrawn | No outcome recorded |
| Phase 1 | NCT04044430 | Aug 2020 → Jul 2022 | colon adenocarcinoma, rectum adenocarcinoma | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 1 | NCT03878719 | Aug 2020 → Aug 2022 | melanoma | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT03864042 | Jan 2018 → Jul 2022 | cancer, metastatic melanoma | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02857270 | Sep 2016 → Feb 2021 | colorectal cancer, metastatic melanoma, non-small cell lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01436656 | Sep 2011 → Oct 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00682227 | Aug 2006 → Dec 2008 | esophageal squamous cell carcinoma | University of Yamanashi | Unknown | No outcome recorded |
| Phase 1/211 trials | ||||||
| Phase 1/2 | NCT06194929 | Mar 2024 → Jan 2028 expected | cutaneous melanoma, metastatic malignant neoplasm in the brain | University of Utah | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05039177 | Sep 2021 → Aug 2025 | colorectal cancer, pancreatic ductal adenocarcinoma | Erasca, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04655157 | May 2021 → Aug 2022 | melanoma | Jason J. Luke, MD | Terminated | No outcome recorded |
| Phase 1/2 | NCT04585815 | Nov 2020 → May 2023 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT04720768 | Jun 2020 → Dec 2024 | melanoma, metastatic neoplasm | Peter MacCallum Cancer Centre, Australia | Unknown | No outcome recorded |
| Phase 1/2 | NCT04017650 | Jun 2019 → Dec 2027 expected | colon adenocarcinoma, rectum adenocarcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03843775 | Feb 2019 → Sep 2023 | neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02902042 | Apr 2018 → Nov 2020 | melanoma | Prof. Dr. med. Dirk Schadendorf | Completed | No outcome recorded |
| Phase 1/2 | NCT02278133 | Dec 2014 → May 2016 | colorectal cancer | Array BioPharma | Completed | No outcome recorded |
| Phase 1/2 | NCT01777776 | Jul 2013 → Apr 2015 | melanoma | Array BioPharma | Terminated | No outcome recorded |
| Phase 1/2 | NCT01543698 | May 2012 → Mar 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 246 trials | ||||||
| Phase 2 | NCT07714447 | Nov 2026 → Feb 2029 expected | colorectal cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07178717 | Oct 2025 → Feb 2028 expected | colorectal cancer | Vall d'Hebron Institute of Oncology | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06887088 | May 2025 → Jan 2028 expected | melanoma | Spanish Melanoma Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06578559 | Jul 2024 → Aug 2026 overdue | colorectal cancer | Gruppo Oncologico del Nord-Ovest | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06640166 | Jun 2024 → Dec 2025 overdue | colon adenocarcinoma | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | No outcome recorded |
| Phase 2 | NCT06411600 | May 2024 → May 2027 expected | colorectal cancer | Vall d'Hebron Institute of Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT06207656 | Apr 2024 → Apr 2029 expected | colorectal cancer | Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) | Recruiting | No outcome recorded |
| Phase 2 | NCT05304546 | Sep 2023 → Jul 2025 | metastatic melanoma | Dr. Ronnie Shapira | Completed | No outcome recorded |
| Phase 2 | NCT05926960 | Jun 2023 → Feb 2026 | melanoma | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT05706779 | Feb 2023 → Dec 2026 expected | colorectal cancer | Federation Francophone de Cancerologie Digestive | Recruiting | No outcome recorded |
| Phase 2 | NCT05725200 | Sep 2022 → Dec 2038 expected | colorectal cancer | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04074096 | Sep 2022 → May 2026 overdue | melanoma, metastatic malignant neoplasm in the brain | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05510895 | Sep 2022 → Jul 2024 | colon carcinoma | AIO-Studien-gGmbH | Completed | No outcome recorded |
| Phase 2 | NCT05308446 | Jul 2022 → Feb 2026 overdue | colon adenocarcinoma, rectum adenocarcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05217446 | Jul 2022 → Jun 2026 overdue | colorectal cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05195632 | Jun 2022 → May 2024 overdue | non-small cell lung carcinoma | Pierre Fabre Laboratories | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05097599 | Apr 2022 → Jun 2024 | cancer | Strata Oncology | Terminated | No outcome recorded |
| Phase 2 | NCT05767879 | Jan 2022 → Jan 2026 | cutaneous melanoma | Leiden University Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT05097378 | Jan 2022 → Sep 2023 | cancer, melanoma | CCTU- Cancer Theme | Unknown | No outcome recorded |
| Phase 2 | NCT05026983 | Dec 2021 → Feb 2027 expected | cutaneous melanoma, metastatic melanoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04221438 | Sep 2021 → Jun 2024 | cutaneous melanoma, metastatic malignant neoplasm in the lymph nodes | ECOG-ACRIN Cancer Research Group | Terminated | No outcome recorded |
| Phase 2 | NCT05004350 | Sep 2021 → Dec 2023 | colorectal cancer | Pierre Fabre Laboratories | Completed | No outcome recorded |
| Phase 2 | NCT04526782 | Jan 2021 → Jul 2025 overdue | non-small cell lung carcinoma | French Cooperative Thoracic Intergroup | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04511013 | Jan 2021 → Jun 2027 expected | acral lentiginous melanoma, metastatic malignant neoplasm in the brain, metastatic melanoma, mucosal melanoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 2 | NCT04390243 | Nov 2020 → Nov 2023 | digestive system carcinoma, metastatic carcinoma | Academic and Community Cancer Research United | Terminated | No outcome recorded |
| Phase 2 | NCT04061980 | Oct 2020 → Dec 2027 expected | differentiated thyroid carcinoma | Providence Health & Services | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04324112 | Oct 2020 → May 2026 overdue | hairy cell leukemia | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03973918 | Jul 2019 → Apr 2022 | anaplastic astrocytoma, anaplastic pleomorphic xanthoastrocytoma, gliosarcoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded |
| Phase 2 | NCT03898908 | Jul 2019 → Oct 2022 | metastatic malignant neoplasm in the brain, metastatic melanoma | Spanish Melanoma Group | Completed | No outcome recorded |
| Phase 2 | NCT03839342 | Jun 2019 → Dec 2026 expected | cancer | University Health Network, Toronto | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03915951 | Jun 2019 → Sep 2022 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT03911869 | Apr 2019 → Jan 2022 | metastatic malignant neoplasm in the brain | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT03693170 | Jan 2019 → Jun 2020 | — | Pierre Fabre Laboratories | Completed | No outcome recorded |
| Phase 2 | NCT03235245 | Oct 2018 → Oct 2023 overdue | melanoma | European Organisation for Research and Treatment of Cancer - EORTC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03563729 | Jun 2018 → Jun 2024 overdue | melanoma | Inge Marie Svane | Recruiting | 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 | NCT02631447 | Nov 2016 → May 2024 | metastatic melanoma | Fondazione Melanoma Onlus | Completed | No outcome recorded |
| Phase 2 | NCT02834364 | Jun 2016 → Mar 2023 | refractory plasma cell neoplasm | University of Heidelberg Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02109653 | Jun 2015 → Nov 2017 | non-small cell lung carcinoma | Array BioPharma | Withdrawn | No outcome recorded |
| Phase 2 | NCT02263898 | Jan 2015 → Dec 2019 | metastatic melanoma | Jonsson Comprehensive Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT02159066 | Jul 2014 → Jan 2023 | melanoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01981187 | Jan 2014 → Sep 2015 | cancer, hematopoietic and lymphoid cell neoplasm | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT01820364 | Nov 2013 → Mar 2015 | melanoma | Array BioPharma | Terminated | No outcome recorded |
| Phase 2 | NCT01894672 | Jul 2013 → Mar 2016 | melanoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01719380 | Nov 2012 → Oct 2015 | colorectal cancer | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00995358 | Nov 2008 → Oct 2010 | esophageal squamous cell carcinoma | University of Yamanashi | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05710406 | Aug 2023 → Jun 2034 expected | colon adenocarcinoma | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT05615818 | Jul 2024 → Jun 2027 expected | biliary tract neoplasm | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT05270044 | May 2022 → Mar 2027 expected | melanoma | Pierre Fabre Laboratories | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04657991 | Jan 2021 → Jan 2026 overdue | melanoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04607421 | Dec 2020 → Mar 2025 overdue | neoplasm | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03803553 | Apr 2020 → Dec 2026 expected | metastasis from malignant tumor of colon | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT02928224 | Oct 2016 → Feb 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01909453 | Sep 2013 → Nov 2016 | melanoma | Pfizer | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07092410 | Aug 2025 → Aug 2030 | melanoma | SRH Wald-Klinikum Gera GmbH | Withdrawn | No outcome recorded |
| Phase 4 | NCT05203172 | Jul 2022 → Jul 2029 expected | cancer | Pfizer | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04801966 | Sep 2021 → Dec 2022 | cancer | Peter MacCallum Cancer Centre, Australia | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07318389 Background | Jun 2026 → Nov 2027 expected | colorectal cancer | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT04903119 Background | Jun 2022 → Jul 2028 expected | metastatic melanoma | Rina Plattner | Recruiting | No outcome recorded |
| Phase 1 | NCT02675946 Background | Feb 2016 → Mar 2023 | digestive system cancer | Curegenix Inc. | Unknown | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06470880 Comparator | Jun 2024 → Jun 2026 overdue | melanoma | The Christie NHS Foundation Trust | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05576896 Background | Oct 2022 → Oct 2025 | colorectal cancer | Northwestern University | Terminated | No outcome recorded |
| Phase 2 | NCT05370807 Background | Oct 2022 → Dec 2024 | metastatic melanoma | University Hospital Brussels | Unknown | No outcome recorded |
Press releases naming this drug 15 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-31 | Pfizer | Pfizer’s BRAFTOVI Regimen Nearly Doubles Median Progression-Free Survival in Metastatic Colorectal Cancer pfizer.com ↗ |
| 2026-02-24 | Pfizer | U.S. FDA Grants Full Approval to Pfizer’s BRAFTOVI Combination Regimen in First-Line Metastatic Colorectal Cancer pfizer.com ↗ |
| 2026-02-17 | Pfizer | Pfizer’s BRAFTOVI Regimen Improves Progression-Free Survival in Metastatic Colorectal Cancer pfizer.com ↗ |
| 2026-01-10 | Pfizer | Pfizer’s BRAFTOVI® Regimen with Additional Chemotherapy Backbone Increased Response Rates for Certain Patients with Metastatic Colorectal Cancer pfizer.com ↗ |
| 2025-10-19 | Pfizer | Pfizer’s BRAFTOVI® + MEKTOVI® Shows Sustained Long-Term Survival in Patients with Advanced Lung Cancer pfizer.com ↗ |
| 2025-05-30 | Pfizer | Pfizer’s BRAFTOVI® Combination Regimen Cuts the Risk of Death in Half for Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer pfizer.com ↗ |
| 2025-02-03 | Pfizer | Pfizer’s BRAFTOVI® Combination Regimen Significantly Improved Progression-Free Survival and Overall Survival in Phase 3 BREAKWATER Trial pfizer.com ↗ |
| 2025-01-25 | Pfizer | Pfizer’s BRAFTOVI® Combination Regimen Demonstrates Improved Response in Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer pfizer.com ↗ |
| 2024-12-20 | Pfizer | U.S. FDA Approves Pfizer’s BRAFTOVI® Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer pfizer.com ↗ |
| 2024-09-14 | Pfizer | Pfizer’s BRAFTOVI® + MEKTOVI® Shows Long-Term Clinically Meaningful Response in Patients with BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer pfizer.com ↗ |
| 2023-10-12 | Pfizer | U.S. FDA Approves Pfizer’s BRAFTOVI® + MEKTOVI® for BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer pfizer.com ↗ |
| 2023-04-04 | Pfizer | FDA Accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI pfizer.com ↗ |
| 2020-04-08 | Pfizer | U.S. FDA Approves BRAFTOVI® (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy pfizer.com ↗ |
| 2019-12-18 | Pfizer | U.S. FDA Accepts and Grants Priority Review to sNDA for BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer After Prior Therapy pfizer.com ↗ |
| 2019-09-29 | Pfizer | Pfizer Presents Interim Analysis Results from Phase 3 BEACON CRC Trial of BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer pfizer.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 93 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | encorafenib | “This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor...” NCT02109653 ↗75“This phase II trial studies intermittent dosing of BRAF inhibitor LGX818 (encorafenib) and MEK inhibitor MEK 162 (binimetinib) in treating patients with melanoma that has...” NCT02263898 ↗ “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 ↗ “Encorafenib and binimetinib delivered to UK standard of care.” NCT06470880 ↗ “Encorafenib: 300 mg (4 × 75 mg oral capsule) daily (QD)” NCT06207656 ↗ “Neoadjuvant Encorafenib, Binimetinib and Cetuximab” NCT05510895 ↗ |
| Known as | Braftovi | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301612 ↗ |
| Known as | ENC | “Here, we present phase I safety results from an open-label, phase I/II study of pembrolizumab (PEM), encorafenib (ENC) and binimetinib (BIN) triplet therapy in advanced, B-Raf...” PMID 34655839 ↗ Oct 20211“encorafenib (ENC)” NCT04657991 ↗ |
| Known as | Enco | “The BEACON CRC study demonstrated that encorafenib (Enco)+cetuximab (Cetux)±binimetinib (Bini) significantly improved overall survival (OS) versus” PMID 39313594 ↗ Sep 2024 |
| Known as | IMP-3 | “Since a phase I clinical trial using three HLA-A24-binding peptides from TTK protein kinase (TTK), lymphocyte antigen-6 complex locus K (LY6K), and insulin-like growth...” PMID 22776426 ↗ Jul 2012 |
| Known as | LGX818 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02263898 ↗ |
| Known as | NVP-LGX-818-NXA | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301612 ↗ |
| Known as | NVP-LGX818 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301612 ↗ |
| Action | Inhibit | “a RAF kinase inhibitor” NCT01436656 ↗ |
| Modality | Small molecule | “A small molecule BRAF inhibitor” NCT04655157 ↗ |
| Route | Oral | “oral doses of LGX818” NCT01436656 ↗ |
| Target | IMP3 | “We previously identified three novel HLA-A24-restricted epitope peptides, which were derived from three cancer-testis antigens, TTK protein kinase (TTK), lymphocyte antigen 6...” PMID 19459850 ↗ May 2009 |