Pfizer Inc.'s (PFE.US) anti-cancer small molecule combination therapy receives accelerated approval from the FDA.

Pfizer Inc. (PFE.US) announced recently that the U.S. FDA has accelerated its approval of the BRAF inhibitor Braftovi (encorafenib) in combination with Erbitux (cetuximab) and the mFOLFOX6 regimen (including fluorouracil, calcium folinate, and oxaliplatin) for the treatment of metastatic colorectal cancer (mCRC) patients with the BRAF V600E mutation. This approval is based on a statistically significant and clinically meaningful increase in response rates in first-line patients observed in the Phase 3 clinical trial BREAKWATER, as well as an extension in the duration of response. The press release notes that this is the first approved combination therapy containing a BRAF-targeted therapy for this patient population. The ongoing BREAKWATER trial is evaluating the efficacy of Braftovi in combination with Erbitux with or without chemotherapy (mFOLFOX6) in the treatment of first-line metastatic colorectal cancer patients with the BRAF V600E mutation. Colorectal cancer is the third most common type of cancer worldwide, with approximately 1.8 million new cases diagnosed globally in 2022. The lifetime risk of developing CRC is approximately 1 in 23 for men and 1 in 25 for women. The BRAF mutation is estimated to occur in 8-10% of metastatic colorectal cancer patients, who have a poorer prognosis. The BRAF V600E mutation is the most common type of BRAF mutation, and CRC patients carrying this mutation have a risk of death more than twice that of patients without the mutation. While the unmet medical need for patients with BRAF V600E mutation metastatic colorectal cancer is high, there previously were no approved biomarker-driven therapies for these first-line patients.