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. https://www.pfizer.com/news/press-release/press-releaseetail/u_s_fda_accepts_and_grants_priority_review_to_snda_for_braftovi_encorafenib_in_combination_with_erbitux_cetuximab_braftovi_doublet_for_the_treatment_of_brafv600e_mutant_metastatic_colorectal_cancer_after_prior
