The FDA accepted Pfizer's supplemental New Drug Application for its combination therapy for advanced BRAF-mutant metastatic colorectal cancer and granted it priority review designation.
What you should know:
1. Pfizer is using a combination of encorafenib and cetuximab to treat mCRC.
2. The combination therapy improved overall survival and objective response rates for mCRC when compared to patients taking cetuximab with irinotecan-containing regimens, according to a study published in the New England Journal of Medicine.
3. If the FDA approves the combination therapy, it would become the first targeted regimen for mCRC patients who harbor a BRAF mutation, said Chris Boshoff, MD, PhD, Pfizer's chief development officer of oncology.
4. BRAF gene mutation occurs in up to 15 percent of patients with mCRC.