FDA gives Pfizer CRC drug priority review — 4 insights

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.

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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.

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