FX.co ★ FDA Grants Accelerated Approval To Pfizer's BRAFTOVI Combination For Metastatic Colorectal Cancer

Pfizer Inc. (PFE) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for BRAFTOVI (encorafenib) to be used in combination with cetuximab (ERBITUX) and the chemotherapy regimen mFOLFOX6, which includes fluorouracil, leucovorin, and oxaliplatin. This treatment is intended for patients with metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation. It is important to note that continued approval is dependent on confirming the clinical benefits of the treatment.

This accelerated approval is one of the first to be processed under the FDA's Project FrontRunner initiative, which aims to expedite the development and approval of innovative cancer therapies for advanced or metastatic diseases.

The approval is based on data demonstrating a statistically significant and clinically meaningful enhancement in both response rate and response duration in treatment-naïve patients. This was observed with the combination of BRAFTOVI, cetuximab, and mFOLFOX6 in the Phase 3 BREAKWATER trial.

This latest approval builds on an earlier authorization by the FDA for the use of BRAFTOVI together with cetuximab for adult patients with mCRC and a BRAF V600E mutation, following previous therapy.