ARRAY BIOPHARMA INC — Braftovi FDA Review (NDA/BLA 210496, 2025)
Pfizer Inc. · 2025 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA is reviewing Array BioPharma's sNDA for accelerated approval of Braftovi (encorafenib) with cetuximab and mFOLFOX6 for BRAF V600E-mutant metastatic colorectal cancer, with a PDUFA date of January 1, 2025. The BREAKWATER trial demonstrated a statistically significant and clinically meaningful improvement in objective response rate (61% vs. 40%) and duration of response (13.9 months) for the combination arm compared to control. The safety profile was acceptable, consistent with known toxicities, and no new signals were identified. Regulatory activities, clinical pharmacology, and study design were reviewed, with the FDA agreeing on the proposed dosing and study methodology. Financial disclosures for investigators were largely clear. Continued approval is contingent on confirmatory trials.
Key findings — cited to the page
| All-causality Grade 5 AEs | 4.3 % | BREAKWATER trial · p.93 |
| All-causality Grade 5 AEs (Control Arm) | 4.4 % | BREAKWATER trial · p.93 |
| Grade 5 treatment-related AEs (Control Arm) | 0.4 % | BREAKWATER trial · p.93 |
| Most frequent (≥5% of participants) all-causality Grade 3 or 4 AEs in EC + mFOLFOX6 Arm: peripheral sensory neuropathy | 5.6 % | Protocol C4221015 · p.100 |
| Most frequent (≥5% of participants) all-causality Grade 3 or 4 AEs in EC + mFOLFOX6 Arm: anemia | 10.8 % | Protocol C4221015 · p.100 |
| Most frequent (≥5% of participants) all-causality Grade 3 or 4 AEs in EC + mFOLFOX6 Arm: neuropathy peripheral | 6.9 % | Protocol C4221015 · p.100 |
| Most frequent (≥5% of participants) all-causality Grade 3 or 4 AEs in EC + mFOLFOX6 Arm: neutrophil count decreased | 18.2 % | Protocol C4221015 · p.100 |
| Most frequent (≥5% of participants) all-causality Grade 3 or 4 AEs in EC + mFOLFOX6 Arm: lipase increased | 14.7 % | Protocol C4221015 · p.100 |
| All-causality Grade 3 or 4 AEs | 74.0 % | Protocol C4221015 · p.99 |
| All-causality Grade 3 or 4 AEs | 61.0 % | Protocol C4221015 · p.99 |
| Most frequent (≥5% of participants) all-causality Grade 3 or 4 AEs in EC + mFOLFOX6 Arm: neutropenia | 14.7 % | Protocol C4221015 · p.100 |
| Most frequent (≥5% of participants) all-causality Grade 3 or 4 AEs in EC + mFOLFOX6 Arm: WBC count decreased | 5.6 % | Protocol C4221015 · p.100 |
Source: Pfizer Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →