The U.S. Food and Drug Administration granted full approval to Pfizer’s BRAFTOVI® (encorafenib) in combination with cetuximab and fluorouracil‑based chemotherapy for adult patients with metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation. The approval, announced on February 24, 2026, follows the drug’s accelerated approval in December 2024 and is based on the Phase 3 BREAKWATER trial.
The BREAKWATER trial demonstrated a median progression‑free survival of 12.8 months for patients receiving encorafenib, cetuximab, and mFOLFOX6, compared with 7.1 months in the control arm, a 47% reduction in the risk of disease progression or death. Median overall survival was 30.3 months versus 15.1 months, and the objective response rate was 61% versus 40%. In the cohort receiving FOLFIRI, the response rate was 64% versus 39%. These results provided the clinical evidence that underpins the full approval.
BRAF V600E mutations occur in roughly 8‑12% of metastatic colorectal cancers and are associated with a poorer prognosis. With this approval, BRAFTOVI becomes the only FDA‑approved targeted therapy for first‑line treatment of BRAF V600E‑mutant mCRC, establishing a new standard of care for a patient group that previously had limited options.
The approval strengthens Pfizer’s oncology pipeline at a time when the company is actively offsetting revenue losses from upcoming patent cliffs on blockbuster drugs such as Eliquis, Ibrance, and Xtandi. Pfizer’s recent acquisition of Seagen and continued investment in targeted therapies signal a strategic pivot toward high‑margin oncology assets that can drive future growth.
"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," said Aamir Malik, Executive Vice President and Chief U.S. Commercial Officer at Pfizer. "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."
The approval not only expands Pfizer’s oncology revenue base but also positions the company to compete more effectively in the targeted‑therapy market. By securing a first‑line indication for a high‑need, mutation‑driven disease, Pfizer gains a competitive edge that can help mitigate the impact of patent expirations and support long‑term growth in its oncology segment.
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