Drugs / Encorafenib
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed colorectal cancer 1 milestone | |||||
| Filed | US (FDA) | BRAFTOVI | colorectal cancer | 2019-12-18 | “the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the Company’s supplemental New Drug Application (sNDA) for BRAFTOVI® (encorafenib)” pfizer.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 81 · started per year
today
US approved 2018
EU approved 2018
1
2
4
3
2
5
5
8
9
13
12
5
8
3
1
20122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04741997 | May 2021 → Apr 2027 expected | 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 112 trials | ||||||
| Phase 1 | NCT06102902 | Jun 2024 → Jan 2027 expected | colorectal adenocarcinoma | National Cancer Institute (NCI) | Recruiting | 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 Stop: Business |
| Phase 1 | NCT04759846 | Jan 2021 → May 2023 | metastatic melanoma | Pierre Fabre Laboratories | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04044430 | Aug 2020 → Jul 2022 | colon adenocarcinoma, rectum adenocarcinoma | University of California, San Francisco | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03878719 | Aug 2020 → Aug 2022 | melanoma | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| 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 1/211 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 Stop: Enrollment |
| Phase 1/2 | NCT04585815 | Nov 2020 → May 2023 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded Stop: Business |
| 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 Stop: Business |
| Phase 1/2 | NCT01543698 | May 2012 → Mar 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 245 trials · 4 met primary · 1 missed | ||||||
| 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 → May 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| Phase 2 | NCT05004350 | Sep 2021 → Dec 2023 | colorectal cancer | Pierre Fabre Laboratories | Completed | Met primary |
| 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 Stop: Enrollment |
| 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 | Met primary |
| Phase 2 | NCT03911869 | Apr 2019 → Jan 2022 | metastatic malignant neoplasm in the brain | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03693170 | Jan 2019 → Jun 2020 | — | Pierre Fabre Laboratories | Completed | Met primary |
| Phase 2 | NCT03235245 | Oct 2018 → Oct 2023 overdue | melanoma | European Organisation for Research and Treatment of Cancer - EORTC | Active not recruiting | Missed primary |
| 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 | Met primary |
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| Phase 2 | NCT01820364 | Nov 2013 → Mar 2015 | melanoma | Array BioPharma | Terminated | No outcome recorded Stop: Business |
| 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 2/31 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 · 3 met primary | ||||||
| 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 → Oct 2026 expected | melanoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04607421 | Dec 2020 → Mar 2025 overdue | neoplasm | Pfizer | Active not recruiting | Met primary |
| Phase 3 | NCT03803553 | Apr 2020 → Dec 2026 expected | metastasis from malignant tumor of colon | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02928224 | Oct 2016 → Feb 2019 | — | Pfizer | Completed | Met primary |
| Phase 3 | NCT01909453 | Sep 2013 → Nov 2016 | melanoma | Pfizer | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07092410 | Aug 2025 → Aug 2030 | melanoma | SRH Wald-Klinikum Gera GmbH | Withdrawn | No outcome recorded Stop: Enrollment |
| 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 Stop: Enrollment |
| Comparator or background therapy6 trials | ||||||
| Phase 0 | NCT07318389 Background | Jun 2026 → Nov 2027 expected | colorectal cancer | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| 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 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 Stop: Enrollment |
| Phase 2 | NCT05370807 Background | Oct 2022 → Dec 2026 expected | metastatic melanoma | University Hospital Brussels | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 30
| Date | Issuer | Release |
|---|---|---|
| 2026-07-14 | Merck KGaA, Darmstadt, Germany | Regulatory European Commission Approves Erbitux® (cetuximab) in Combination with Encorafenib and FOLFOX for First-Line Treatment of Metastatic Colorectal Cancer with BRAF V600E Mutation emdgroup.com ↗
Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that the European Commission (EC) approved an update to the Erbitux (cetuximab) EU label on June 26, 2026. |
| 2026-05-31 | Pfizer | Results Pfizer’s BRAFTOVI Regimen Nearly Doubles Median Progression-Free Survival in Metastatic Colorectal Cancer pfizer.com ↗
Results for the key secondary endpoint of progression-free survival (PFS) by BICR, being presented at ASCO, show median PFS was nearly doubled with the BRAFTOVI combination regimen (15.2 months) versus the comparator (8.3 months). |
| 2026-04-21 | Pfizer | Results Pfizer Showcases Oncology Innovation and Next-Generation Pipeline at ASCO 2026 pfizer.com ↗
These pivotal data further establish the benefit of this BRAFTOVI regimen following the U.S. Food and Drug Administration (FDA) full approval and the topline results announcement for objective response rate (ORR) from this Cohort earlier this year. |
| 2026-03-17 | Verastem, Inc. | Results Verastem Oncology Announces Late Breaking and Regular Abstracts Accepted for Presentation at the AACR Annual Meeting 2026 verastem.com ↗
In mutant BRAF-driven models, the combination of the FAK inhibitor VS-4718 and the RAF/MEK clamp avutometinib, with or without the mutant BRAF inhibitor encorafenib, significantly delayed tumor onset, induced regression of established tumors and brain metastases, and prolonged overall survival. |
| 2026-02-24 | Pfizer | Regulatory U.S. FDA Grants Full Approval to Pfizer’s BRAFTOVI Combination Regimen in First-Line Metastatic Colorectal Cancer pfizer.com ↗
Pfizer Inc . (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to BRAFTOVI ® (encorafenib) in combination with cetuximab (marketed as ERBITUX ® ) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase 3 BREAKWATER trial ( NCT04607421 ). |
| 2026-02-17 | Pfizer | Results Pfizer’s BRAFTOVI Regimen Improves Progression-Free Survival in Metastatic Colorectal Cancer pfizer.com ↗
The BRAFTOVI regimen demonstrated a statistically significant and clinically meaningful improvement in PFS, a key secondary endpoint, as assessed by blinded independent central review (BICR) compared to treatment with FOLFIRI with or without bevacizumab. |
| 2026-01-13 | Ono Pharmaceutical Co., Ltd. | Regulatory Additional Approval of Combination Therapy with BRAFTOVI® Capsule, a BRAF Inhibitor, for the Indication of Colorectal Cancer in South Korea ono-pharma.com ↗
Combination therapy with Braftovi, cetuximab, and chemotherapy was approved in South Korea based on the results of clinical trial for the first-line treatment of unresectable, advanced or recurrent colorectal cancer with BRAF mutation |
| 2026-01-10 | Pfizer | Results Pfizer’s BRAFTOVI® Regimen with Additional Chemotherapy Backbone Increased Response Rates for Certain Patients with Metastatic Colorectal Cancer pfizer.com ↗
Cohort 3 analysis from the BREAKWATER study shows objective response rate of 64% with BRAFTOVI plus cetuximab and FOLFIRI compared to 39% with standard-of-care treatment FOLFIRI with or without bevacizumab |
| 2025-11-20 | Ono Pharmaceutical Co., Ltd. | Regulatory Ono Receives Supplemental Approval of Combination Therapy with BRAFTOVI® Capsule, a BRAF Inhibitor, for the Indication of Colorectal Cancer ono-pharma.com ↗ |
| 2025-10-19 | Pfizer | Results Pfizer’s BRAFTOVI® + MEKTOVI® Shows Sustained Long-Term Survival in Patients with Advanced Lung Cancer pfizer.com ↗
In treatment-naïve patients, the median overall survival (OS) was 47.6 months (95% confidence interval [CI], 31.3, not estimable) after a median follow-up of 52.3 months. |
| 2025-05-30 | Pfizer | Results Pfizer’s BRAFTOVI® Combination Regimen Cuts the Risk of Death in Half for Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer pfizer.com ↗
Median OS was 30.3 months (95% CI, 21.7, Not Estimated) with BRAFTOVI in combination with cetuximab and mFOLFOX6 compared to 15.1 months with chemotherapy with or without bevacizumab (95% CI, 13.7, 17.7). |
| 2025-02-04 | Ono Pharmaceutical Co., Ltd. | Results Pfizer’s BRAFTOVI® Combination Regimen Significantly Improved Progression-Free Survival and Overall Survival in Phase 3 BREAKWATER Trial ono-pharma.com ↗ |
| 2025-02-03 | Pfizer | Results Pfizer’s BRAFTOVI® Combination Regimen Significantly Improved Progression-Free Survival and Overall Survival in Phase 3 BREAKWATER Trial pfizer.com ↗
The trial showed a statistically significant and clinically meaningful improvement in PFS, one of its dual primary endpoints, as assessed by blinded independent central review (BICR) compared to patients receiving chemotherapy with or without bevacizumab. |
| 2025-01-29 | K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc | Results Zentalis Pharmaceuticals Shares Updated Clinical Data Demonstrating Meaningful Azenosertib Activity In Cyclin E1+, Platinum-Resistant Ovarian Cancer zentalis.com ↗
Topline results as of the November 25, 2024 data cutoff can be found in the appendix of the presentation. |
| 2025-01-25 | Pfizer | Results Pfizer’s BRAFTOVI® Combination Regimen Demonstrates Improved Response in Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced positive results from the Phase 3 BREAKWATER trial evaluating BRAFTOVI ® (encorafenib) in combination with cetuximab (marketed as ERBITUX ® ) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. |
| 2024-12-23 | Ono Pharmaceutical Co., Ltd. | Regulatory U.S. FDA Approves Pfizer’s BRAFTOVI® Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer ono-pharma.com ↗ |
| 2024-12-20 | Pfizer | Regulatory U.S. FDA Approves Pfizer’s BRAFTOVI® Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer pfizer.com ↗
BRAFTOVI in combination with cetuximab and mFOLFOX6 is the first and only combination regimen with targeted therapy approved for use as early as first-line for patients with metastatic colorectal cancer with a BRAF V600E mutation |
| 2024-09-14 | Pfizer | Results Pfizer’s BRAFTOVI® + MEKTOVI® Shows Long-Term Clinically Meaningful Response in Patients with BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced longer-term follow-up results from the Phase 2 single-arm PHAROS clinical trial evaluating the efficacy and safety of BRAFTOVI ® (encorafenib) in combination with MEKTOVI ® (binimetinib) for patients with BRAF V600E - mutant metastatic non-small cell lung cancer (NSCLC). |
| 2024-05-17 | Ono Pharmaceutical Co., Ltd. | Regulatory Ono Receives Approvals of BRAFTOVI® and MEKTOVI® for Expanded Use for Two New Indications in Japan ono-pharma.com ↗
These approvals are based on the results of a Phase 2 study (ONO-7702/7703-03), conducted in Japan in 22 patients with unresectable BRAF V600 -mutant thyroid cancer, including 5 patients with anaplastic thyroid cancer. |
| 2023-10-12 | Pfizer | Regulatory U.S. FDA Approves Pfizer’s BRAFTOVI® + MEKTOVI® for BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI ® (encorafenib) + MEKTOVI ® (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. |
| 2023-06-05 | Erasca, Inc. | Results Erasca Provides Update on Clinical Program for ERK Inhibitor ERAS-007 and Refines Pipeline erasca.com ↗
ERAS-007 100 mg BID-QW + encorafenib + cetuximab (EC) in EC-naïve patients with BRAFm CRC showed a 50% (3/6) response rate (2 cPR, 1 uPR), reinforcing ERAS-007 as a potential best-in-class ERK inhibitor |
| 2023-05-31 | Ono Pharmaceutical Co., Ltd. | Regulatory ONO Submits Supplemental Applications for Approval of BRAFTOVI® Capsule and MEKTOVI® Tablet in Japan for the Treatment of Radically Unresectable BRAF-Mutant Thyroid Cancer ono-pharma.com ↗ |
| 2023-05-25 | Erasca, Inc. | Results Erasca to Present Promising Preliminary HERKULES-3 Phase 1b Data at the 2023 ASCO Annual Meeting erasca.com ↗
Triplet of ERAS-007 100 mg BID-QW + encorafenib + cetuximab (EC) in EC-naïve patients with metastatic BRAF V600E-mutated colorectal cancer (CRC) showed a 40% (2/5) response rate; |
| 2023-04-04 | Pfizer | Regulatory FDA Accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI ® (encorafenib) + MEKTOVI ® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. |
| 2021-09-28 | Eli Lilly and Company | Regulatory FDA Expands Lilly's ERBITUX® (cetuximab) Label with Combination of BRAFTOVI® (encorafenib) for the Treatment of BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) after Prior Therapy lilly.com ↗
With this approval, ERBITUX has now received seven FDA approvals to treat certain types of CRC and squamous cell carcinoma of the head and neck. |
| 2021-08-20 | Ono Pharmaceutical Co., Ltd. | Regulatory BRAFTOVI® Capsule, a BRAF Inhibitor, Approved in South Korea for Treatment of Advanced or Recurrent BRAF V600E -Mutant Colorectal Cancer ono-pharma.com ↗
received a marketing approval of BRAFTOVI® (generic name: encorafenib) Capsule 75mg (“BRAFTOVI”), a BRAF inhibitor, on August 19, 2021 from the Ministry of Food and Drug Safety (MFDS) in South Korea |
| 2020-06-03 | Pierre Fabre Medicament | Regulatory Pierre Fabre receives European approval for BRAFTOVI® (encorafenib) pierre-fabre.com ↗
Pierre Fabre today announced that the European Commission (EC) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as Erbitux®) for the treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy. |
| 2020-04-08 | Pfizer | Regulatory 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 ↗
BRAFTOVI plus cetuximab is the first-and-only FDA-approved targeted regimen specifically for adults with previously treated metastatic CRC with a BRAF V600E mutation |
| 2019-12-18 | Pfizer | Regulatory 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 | Results 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 ↗
The BRAFTOVI Triplet also demonstrated a significantly improved ORR of 26% (95% CI: 18%, 35%) compared to 2% (95% CI: 0%, 7%) for Control (p<0.0001). |
All press releases naming this drug 32 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 90 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 | LGX818 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01820364 ↗ |
| 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 | BRAF | “BRAF Inhibitor” NCT01894672 ↗ |