The U.S. Food and Drug Administration (FDA) recently granted full approval to Pfizer’s Braftovi combination regimen for treating advanced colon cancer.
The approval allows doctors to use Pfizer’s Braftovi (encorafenib), together with Eli Lilly’s Erbitux (cetuximab) and standard chemotherapy, to treat adults whose colorectal cancer has spread to other parts of the body and carries a specific genetic mutation called BRAF V600E.
The FDA first gave the drug combination “accelerated approval” in December 2024 because it showed strong results in shrinking tumors in patients. On Feb. 24, Pfizer announced the FDA has upgraded that to full approval because a global Phase 3 clinical trial showed patients who received the treatment had longer progression-free survival and lived longer overall.
Specifically, patients on the new combination were 51% less likely to die and 47% less likely to experience disease progression or death during the study period compared to those on standard treatment.
“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, EVP and Chief U.S. Commercial Officer, 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,” he said.
“This approval reinforces our leadership in bringing differentiated, potentially practice‑changing cancer therapies to patients and healthcare providers who urgently need improved options,” Malik said.
Scott Kopetz, M.D. Ph.D., the Deputy Chair of Gastrointestinal Medical Oncology at the University of Texas MD Anderson Cancer Center and the co-principal investigator of the Breakwater trial, said the FDA full approval will give oncologists confidence to use Braftovi plus cetuximab in combination with fluorouracil-based chemotherapy as a first-line standard of care for patients with the BRAF V600E-mutation.
“The Breakwater study demonstrated that these targeted combination regimens provided statistically significant benefit, providing the robust evidence we need to make treatment decisions that can meaningfully impact patient outcomes,” Kopetz said.
Colorectal cancer is the third most common cancer in the world and the second leading cause of cancer-related deaths. Patients with the BRAF-600E mutation, the most common type of BRAF mutation, have a mortality risk that is more than double that of colon cancer patients without the mutation.
