Pfizer's BRAFTOVI Gains FDA Approval for Colorectal Cancer Treatment

Published 1 days agoPFE

Pfizer's BRAFTOVI Gains FDA Approval for Colorectal Cancer Treatment

Pfizer's BRAFTOVI® (encorafenib) has reached an important milestone in the fight against metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. The U.S. Food and Drug Administration (FDA) granted accelerated approval for BRAFTOVI in combination with cetuximab and mFOLFOX6 in December 2024, specifically for treatment-naïve patients. This decision was based on a significant improvement in the confirmed objective response rate (ORR).

The positive Phase 3 BREAKWATER trial results have reinforced the benefits of Pfizer’s combination therapy. The regimen achieved a remarkable 61% ORR, which is a significant increase compared to the 40% seen with standard chemotherapy, according to BioSpace. Additionally, the combination demonstrated a notable improvement in progression-free survival (PFS), and an interim analysis pointed to a promising trend in overall survival, indicating a 53% reduction in the risk of death compared to chemotherapy.

Pfizer reports that the safety profile of BRAFTOVI, when used with cetuximab and mFOLFOX6, is consistent with known safety profiles of these drugs, without introducing new safety concerns. These developments highlight the combination's potential to enhance patient outcomes and possibly establish a new treatment benchmark for those with BRAF V600E-mutant mCRC.

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