Friday, December 8, 2023
HomeLatest Pharma-NewsU.S. FDA approved priority review to sNDA for Braftovi® (encorafenib) in combination...

U.S. FDA approved priority review to sNDA for Braftovi® (encorafenib) in combination with erbitux® (cetuximab) (braftovi doublet) for the treatment of Brafv600e-mutant metastatic colorectal cancer after previous therapies

Dec 18, 2019: Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved priority review to the Company’s supplemental New Drug Application (sNDA) for BRAFTOVI® (encorafenib) in combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) based on results from the Phase 3 BEACON CRC trial, which evaluated the effectiveness and safety of BRAFTOVI in combination with ERBITUX with or without MEKTOVI® (binimetinib) in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), subsequent one or two lines of therapy.

The FDA grants Priority Review to the medicines that may offer noteworthy advances in treatment or may provide a treatment where no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for the decision by the FDA is in April 2020.


Please enter your comment!
Please enter your name here

- Advertisment -

Most Popular