The U.S. Food and Drug Administration (FDA) has granted full approval to Pfizer Inc.’s Braftovi, or encorafenib, when used with Eli Lilly’s Erbitux (cetuximab) and fluorouracil‑based chemotherapy for adults with metastatic colorectal cancer carrying a BRAF V600E mutation. The decision is based on the Phase 3 Breakwater trial, which showed improvements in progression‑free and overall survival.

The therapy previously received accelerated approval in December 2024 after demonstrating a higher objective response rate, one of the study’s primary endpoints. Full approval reflects results from the randomized portion of the trial examining Braftovi with cetuximab and mFOLFOX6, along with response‑rate data from a separate cohort evaluating the regimen with FOLFIRI.

“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, Pfizer’s Chief U.S. Commercial Officer. “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.”

Pfizer said the safety profile of the regimens aligned with previously observed effects, and no new safety signals emerged. In the mFOLFOX6 arm, common adverse events included peripheral neuropathy, nausea, fatigue, diarrhea, decreased appetite, rash, vomiting, hemorrhage, abdominal pain, arthralgia, fever, and constipation. In the FOLFIRI arm, frequently reported side effects included nausea, diarrhea, fatigue, vomiting, hair loss, constipation, abdominal pain, decreased appetite, and rash.

Permanent discontinuation of Braftovi occurred in 14% of patients receiving the mFOLFOX6 combination and 9% of those treated with the FOLFIRI regimen. Pfizer reported no significant difference in chemotherapy discontinuation rates between the Braftovi combination arm and the control group.

The combination with mFOLFOX6 is also under review by European regulators. Pierre Fabre Laboratories, which holds commercialization rights in the region, has recently secured approvals in several other countries.

More Pfizer News

On September 30th, Pfizer entered an agreement with the Trump Administration to lower prices for its prescription drugs.