FDA gives priority review to Braftovi Doublet in metastatic colorectal cancer.- Pfizer

Pfizer announced that the FDA has accepted and granted priority review to the Company�s supplemental New Drug Application (sNDA) for Braftovi Doublet which consists of Braftovi (encorafenib) in combination with Erbitux (cetuximab), based on results from the Phase III BEACON CRC trial, which evaluated the efficacy and safety of Braftovi in combination with Erbitux with or without Mektovi (binimetinib) in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), following one or two lines of therapy. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in April 2020. On November 2, 2019, the European Medicines Agency (EMA) also started the review procedure for Pierre Fabre�s Type II variation applications based on the BEACON CRC trial.

As published in The New England Journal of Medicine (NEJM), results from the BEACON CRC trial showed improvements in overall survival (OS) and objective response rates (ORR) for both the Braftovi Doublet and Braftovi Triplet (Braftovi, Mektovi and Erbitux) combination, compared to Erbitux plus irinotecan-containing regimens (Control). In descriptive analyses comparing the Doublet and Triplet arms, the results showed comparable efficacy between the Doublet and Triplet in the overall population. The Braftovi Triplet and Doublet showed no unexpected toxicities.