FDA grants full approval to Pfizer BRAFTOVI regimen for colorectal cancer

The U.S. Food and Drug Administration granted traditional full approval on Feb. 24, 2026 to BRAFTOVI (encorafenib) in combination with cetuximab (ERBITUX) and fluorouracil‑based chemotherapy as a first‑line treatment for adult patients with metastatic colorectal cancer (mCRC) harboring the BRAF V600E mutation, as detected by an FDA‑authorized test.

Pfizer said the conversion from the drug’s December 2024 accelerated approval to full approval was based on results from the global Phase 3 BREAKWATER trial (NCT04607421). The company and the FDA identified progression‑free survival (PFS) and overall survival (OS) benefits from the Phase 3 portion that evaluated encorafenib plus cetuximab and mFOLFOX6, along with objective response rate (ORR) data from Cohort 3, which evaluated encorafenib plus cetuximab with FOLFIRI, as the evidentiary basis for the traditional approval.

In a formal statement, the FDA said, “The Food and Drug Administration granted traditional approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) in combination with cetuximab and fluorouracil‑based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA‑authorized test.” The agency noted that full prescribing information for Braftovi will be posted on Drugs@FDA.

Pfizer framed the approval as a potential shift in first‑line care. Aamir Malik, executive vice president and chief U.S. commercial officer at Pfizer, said, “This landmark approval, achieved through the robust clinical benefit demonstrated in the BREAKWATER trial, validates that this targeted therapy can impact outcomes for people living with an aggressive, hard‑to‑treat cancer.” Malik added, “As the only targeted combination regimen shown to deliver a significant improvement in certain outcomes for patients with BRAF V600E‑mutant metastatic colorectal cancer, BRAFTOVI is uniquely positioned to redefine first‑line treatment and establish a new standard of care. This approval reinforces our leadership in bringing differentiated, potentially practice‑changing cancer therapies to patients and healthcare providers who urgently need improved options.”

Chris Boshoff, Pfizer’s chief oncology officer, also commented in the company release, saying, “For more than a decade, Pfizer has been a pioneer in delivering targeted therapies for molecular‑driven cancers. With today’s accelerated approval of the BRAFTOVI regimen, patients with metastatic colorectal cancer with a BRAF V600E mutation now have a first‑line treatment option, which contains a targeted therapy specifically for a mutation that is driving their cancer.” Boshoff additionally referenced ongoing research, including exploration of a next‑generation brain‑penetrant BRAF inhibitor.

Regulatory notes attached to Pfizer’s announcement said the application received priority review, was reviewed through the FDA Real‑Time Oncology Review pilot, and was processed under Project Orbis with partner reviews ongoing in Canada and Brazil. Pfizer indicated it is discussing BREAKWATER data with other regulators to support potential future filings.

Public materials distributed with the announcement do not include numeric efficacy or safety statistics, dosing details, enrollment numbers, or adverse event rates. The Pfizer press release also contains legacy language referencing accelerated‑approval contingency that appears inconsistent with the FDA’s statement of traditional approval; Pfizer and the FDA declined to provide further detail in the distributed materials. The FDA posting of full prescribing information and the release of the BREAKWATER dataset or primary manuscript will be the critical next sources for clinicians, payers, and patients seeking concrete measures of benefit and safety, and to clarify labeling and companion diagnostic guidance.