Also known as: Braftovi, BRAFTOVI
Encorafenib is an oral BRAF-targeted antineoplastic agent marketed as Braftovi, used in biomarker-selected melanoma, colorectal cancer, and non-small cell lung cancer settings, typically in combination regimens. It inhibits key kinases in the MAPK pathway and is prescription-only. The FDA first approved it in 2018.
Phase 3 BREAKWATER found encorafenib plus cetuximab plus FOLFIRI improved PFS and response in first-line BRAF V600E-mutant metastatic colorectal cancer. OS data remain immature.
A FAERS database analysis identified 13 FDA-approved systemic medications with disproportionately high uveitis reporting signals among 7,301 events from 2003 to 2024. The strongest signals were for cidofovir and rifabutin, and the findings were described as hypothesis-generating rather than causal.
Pfizer reported positive Phase 3 trial results for BRAFTOVI combination therapy in metastatic colorectal cancer and received FDA Priority Review for HYMPAVZI expansion to hemophilia patients including children.
Phase 3 BREAKWATER trial shows encorafenib plus cetuximab and chemotherapy achieved 30.3 months median overall survival versus 15.1 months with standard therapy in previously untreated BRAF V600E-mutant metastatic colorectal cancer.
Pfizer announced positive progression-free survival results from the BREAKWATER trial evaluating Braftovi in combination with cetuximab and Folfiri in previously untreated metastatic colorectal cancer patients with BRAF V600E mutation.
Pfizer announced positive results from Cohort 3 of the Phase 3 BREAKWATER trial, showing BRAFTOVI combined with cetuximab and FOLFIRI significantly improved progression-free survival in previously untreated BRAF V600E-mutant metastatic colorectal cancer patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07318389 |
ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT06578559 |
Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06411600 |
Combination Therapy for BRAF-V600E Metastatic CRCm |
RECRUITING | PHASE2 |
| NCT06194929 |
Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma |
RECRUITING | PHASE1/PHASE2 |
| NCT06102902 |
Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer |
SUSPENDED | PHASE1 |
| NCT05985954 |
Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy |
RECRUITING | PHASE1 |
| NCT05926960 |
A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients With Advanced Melanoma |
TERMINATED | PHASE2 |
| NCT05743036 |
ZN-c3 in Adult Participants With Metastatic Colorectal Cancer |
TERMINATED | PHASE1 |
| NCT05725200 |
Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer |
RECRUITING | PHASE2 |
| NCT05710406 |
Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer |
ACTIVE_NOT_RECRUITING | PHASE2/PHASE3 |
