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
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
Receives 3 final and 2 tentative product approvals thus far in Q1FY25
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