Posted by Michael Wonder on 23 Aug 2016
FDA accepts Clovis Oncology's new drug application for rucaparib for priority review for the treatment of advanced mutant BRCA ovarian cancer
23 August 2016 - Seeking approval for mutant BRCA patients treated with two or more prior therapies.
Clovis Oncology announced today that the U.S. FDA has accepted Clovis’ new drug application for accelerated approval of rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act date of February 23, 2017.
In late June 2016, Clovis completed its NDA submission of rucaparib to the FDA for the treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations (as detected by an FDA-approved test), and who have been treated with two or more chemotherapies.
Rucaparib was granted breakthrough therapy designation for the proposed indication by the FDA in April 2015.
