On Dec. 20, 2024, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved BRAFTOVI^® (encorafenib) in combination with cetuximab (marketed as ERBITUX^® ) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.

The indication was approved based on a statistically significant and clinically meaningful improvement in response rate and durability of response in treatment-naïve patients treated with BRAFTOVI in combination with cetuximab and mFOLFOX6 from the Phase 3 BREAKWATER trial. Continued approval for this indication is contingent upon verification of clinical benefit. This accelerated approval was among the first in the industry to be conducted under the FDA’s Project FrontRunner, which seeks to support the development and approval of new cancer drugs for advanced or metastatic disease.

CRC is the third most common type of cancer in the world, with approximately 1.8 million new diagnoses in 2022. Overall, the lifetime risk of developing CRC is about 1 in 23 for men and 1 in 25 for women. In the U.S. alone, an estimated 152,810 people will be diagnosed with cancer of the colon or rectum in 2024, and approximately 53,000 are estimated to die from the disease each year. For 20% of those diagnosed with CRC, the disease has metastasized, or spread, making it harder to treat.