Shots:
- The US FDA has granted full approval to Braftovi + cetuximab & fluorouracil-based CT for the treatment of adults with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation
- Approval was backed by the P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in pts, randomized to Braftovi + cetuximab (n=158), Braftovi + cetuximab + mFOLFOX6 (n=236), or CT (mFOLFOX6/ FOLFOXIRI/ CAPOX) ± Avastin (n=243)
- The conversion to full approval is supported by significant improvements in PFS (other 1EP) & OS (2EP) of BRAFTOVI plus cetuximab & mFOLFOX6, along with ORR data from Cohort 3 evaluating BRAFTOVI with cetuximab & FOLFIRI
Ref: Pfizer | Image: Pfizer | Press Release
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