The U.S. Food and Drug Administration (FDA) has granted full approval to Pfizer’s Braftovi combination regimen for the treatment of advanced colon cancer. This decision allows healthcare providers to use Braftovi (encorafenib), in combination with Eli Lilly’s Erbitux (cetuximab) and standard chemotherapy, for adults whose colorectal cancer has metastasized and who have the BRAF V600E genetic mutation.
Previously, in December 2024, the FDA had provided accelerated approval for this drug combination due to promising results in tumor reduction. On February 24, Pfizer announced that the FDA upgraded this status to full approval following a global Phase 3 clinical trial. The study found that patients receiving the combination therapy experienced longer progression-free survival and overall survival compared to those on standard treatment.
According to data from the trial, patients treated with the new regimen were 51% less likely to die and 47% less likely to experience disease progression or death during the study period than those on standard care.
“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 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,” he added.
“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., Deputy Chair of Gastrointestinal Medical Oncology at University of Texas MD Anderson Cancer Center and co-principal investigator of the Breakwater trial commented on the significance of this decision: “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.”
Colorectal cancer ranks as the third most common type of cancer globally and is second in causing cancer-related deaths. Patients carrying the BRAF-600E mutation—the most prevalent form of BRAF mutation—face more than double the mortality risk compared with colon cancer patients without this mutation.
