Pfizer (PFE) Secures Full FDA Approval for BRAFTOVI as First-Line Treatment in mCRC

Pfizer Inc. (NYSE:PFE) is one of the most undervalued stocks under $30 to buy. On February 24, the US FDA granted full approval to Pfizer’s BRAFTOVI (encorafenib) in combination with cetuximab and fluorouracil-based chemotherapy for the first-line treatment of adults with BRAF V600E-mutant metastatic colorectal cancer/mCRC. This decision converts a previous accelerated approval into a full one, establishing the regimen as a new standard of care.

The update allows doctors to use BRAFTOVI alongside different chemotherapy options, such as mFOLFOX6 or FOLFIRI, providing more flexibility in treating this aggressive form of cancer. The approval is based on the Phase 3 BREAKWATER trial, which showed that the BRAFTOVI combination significantly improved patient outcomes compared to standard chemotherapy.

Data revealed a 51% reduction in the risk of death and a 47% reduction in the risk of disease progression. Patients receiving the BRAFTOVI and mFOLFOX6 combination saw their median overall survival double to 30.3 months, compared to 15.1 months for those on standard chemotherapy treatments. The safety profile of these combinations was consistent with previous studies of the individual drugs.

Pfizer Inc. (NYSE:PFE) discovers, develops, manufactures, markets, distributes, and sells biopharmaceutical products in the US and internationally.

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