Joanna Sadowska, Biopharma Account Specialist at Nanolive SA, shared a post on LinkedIn:
“BREAKING NEWS – FDA approves BRAFTOVI as first-line treatment for metastatic colorectal cancer – 51% reduction in death risk.
Pfizer gets FDA approval for BRAFTOVI (encorafenib) in combination with cetuximab and fluorouracil-based chemotherapy for previously untreated BRAF V600E-mutant metastatic colorectal cancer (mCRC).
This is the only approved targeted regimen in the first-line setting for this population.
BRAF V600E mutations occur in ~8–12% of mCRC cases and are associated with a particularly poor prognosis.
The approval was based on Phase 3 BREAKWATER results:
51% reduction in risk of death (HR 0.49)
Median OS: 30.3 months vs 15.1 months
Median PFS: 12.8 months vs 7.1 months
64% ORR vs 39% (FOLFIRI cohort)
No new safety signals identified”
Other articles from Pfizer on OncoDaily.