USFDA Approves Pfizer's BRAFTOVI Combo for BRAF V600E mCRC

Pfizer Inc revealed that the US Food and Drug Administration (FDA) has authorized BRAFTOVI (encorafenib) alongside cetuximab (sold as ERBITUX) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for treating patients with metastatic colorectal cancer (mCRC) exhibiting a BRAF V600E mutation, identified through an FDA-approved test.

The indication received approval due to a statistically significant and clinically relevant enhancement in response rates and the durability of response among treatment-naïve patients receiving BRAFTOVI alongside cetuximab and mFOLFOX6, as demonstrated in the phase 3 BREAKWATER trial. Ongoing approval for this indication depends on confirmation of clinical benefit. This fast-tracked approval is one of the first in the industry to occur under the US FDA’s Project FrontRunner, aimed at facilitating the development and approval of new cancer medications for advanced or metastatic conditions.

“Historically, treatment options have been limited and outcomes poor for patients diagnosed with metastatic colorectal cancer with BRAF mutations,” said Scott Kopetz, professor and deputy chair of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center and co-principal investigator of the BREAKWATER trial. “As the first and only combination regimen featuring a BRAF-targeted therapy for this patient population, usable even in first-line treatment, the encorafenib regimen has demonstrated high response rates that are rapid and durable. This represents an encouraging sign of continued disease control and a source of renewed hope for patients.”