Pfizer’s Braftovi (Encorafenib) Secures the US FDA’s Accelerated Approval as a 1L Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer
Shots:
- The US FDA has granted accelerated approval to Braftovi + cetuximab & mFOLFOX6 for BRAF V600E-mutant mCRC, based on P-III (BREAKWATER) study. Full approval depends upon verification of these results
- The P-III study assessed Braftovi (300mg, PO, QD) in untreated BRAF V600E-mutant mCRC patients, randomized to Braftovi + cetuximab (n=158), Braftovi + cetuximab + mFOLFOX6 (n=236), or standard CT (mFOLFOX6, FOLFOXIRI, or CAPOX) ± bevacizumab (n=243)
- Study achieved dual 1EPs, showing ORR of 61% & mDoR of 13.9mos. with Braftovi + cetuximab & CT vs 40% & 11.1mos. with CT ± bevacizumab; trial is underway & full data will be highlighted at future conferences. Results are under review by global regulatory bodies for future approvals of the regimen
Ref: Pfizer | Image: Pfizer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
