Pfizer received full FDA approval for its Braftovi (encorafenib) combination regimen as a first-line treatment for adult patients with BRAF V600E-mutant metastatic colorectal cancer.
The approval covers Braftovi in combination with cetuximab and fluorouracil-based chemotherapy, including mFOLFOX6 and FOLFIRI, according to a Feb. 24 news release. The decision was based on phase 3 trial data, which showed a 51% reduction in risk of death and a 47% reduction in disease progression or death compared with chemotherapy, with or without bevacizumab.
Braftovi had previously received accelerated approval in December 2024 based on objective response rates. The FDA’s conversion to full approval followed confirmation of overall survival and progression-free survival benefits.
Among patients in the mFOLFOX6 arm, 14% discontinued Braftovi due to adverse reactions. For the FOLFIRI arm, 9% of patients discontinued treatment. The safety profiles remained consistent with known risks, with no new safety signals identified.
Pfizer said the combination is the only approved targeted regimen for first-line treatment of this mutation subtype.
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