Posted by Michael Wonder on 18 Dec 2019
U.S. FDA accepts and grants priority review to sNDA for Braftovi (encorafenib) in combination with Erbitux (cetuximab) (Braftovi doublet) for the treatment of BRAF V600E-mutant metastatic colorectal cancer after prior therapy
18 December 2019 - Pfizer today announced that the U.S. FDA has accepted and granted priority review to the Company’s supplemental new drug application for Braftovi (encorafenib) in combination with Erbitux (cetuximab) (Braftovi doublet) based on results from the Phase 3 BEACON CRC trial, which evaluated the efficacy and safety of Braftovi in combination with Erbitux with or without Mektovi (binimetinib) in patients with advanced BRAF V600E-mutant metastatic colorectal cancer, 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 goal date for a decision by the FDA is in April 2020.
On November 2, 2019, the EMA also started the review procedure for Pierre Fabre’s Type II variation applications based on the BEACON CRC trial.
