Drug Approval | December 21, 2024
USFDA approves Encorafenib plus Cetuximab and Chemo in BRAF V600E-positive mCRC
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market
The results confirm the study’s primary endpoint of objective response rate and now deliver a striking signal in progression-free survival
Pharma giant targets new standards of care
BRAFTOVI in combination with cetuximab and mFOLFOX6 had previously received accelerated approval in December 2024 based on objective response rate (ORR) results
BREAKWATER is a Phase 3, randomized, open-label trial testing BRAFTOVI in combination with cetuximab, either alone or with chemotherapy, in patients with untreated BRAF V600E-mutant mCRC
The trial supports the potential for another chemotherapy backbone option that may be paired with encorafenib plus cetuximab in this patient population
Results from the Phase 2 PHAROS trial potentially establish new benchmark with targeted combination therapies for this patient population
Pivotal results from the Phase 3 Breakwater trial showed 51% risk reduction in death compared to standard-of-care treatment
BRAFTOVI combination regimen is the first and only targeted therapy approvedby the U.S. FDA for treatment-naïve patients with metastatic colorectal cancer with a BRAF V600E mutation
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