FDA accepts Braftovi sNDA for priority review

19 December 2019

The US Food and Drug Administration has accepted US pharm giant Pfizer’s (NYSE: PFE) supplemental New Drug Application (sNDA) for Braftovi (encorafenib), in combination with Erbitux (cetuximab; Braftovi Doublet) based on the results from the Phase III BEACON CRC trial.

This acceptance marks the first regulatory milestone in the USA since Pfizer’s acquisition of Array Biopharma, which was developing the product in partnership with France’s Pierre Fabre, in July this year in an $11.4 billion transaction.

The Phase III BEACON CRC trial 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.

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