Drug Approval | April 12, 2025
FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
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
Pharma giant targets new standards of care
The study targets patients with refractory, unresectable microsatellite-stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC)
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
Stivarga is the standard third-line treatment for metastatic colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma
This strategic collaboration represents the third clinical trial under Senhwa’s five-year NCI-sponsored cancer research program
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