FDA accepts an NDA from Clovis Oncology for rucaparib to treat advanced ovarian cancer in patients with deleterious BRCA-mutated tumors.
Clovis Oncology, Inc. announced that the FDA has accepted Clovis� New Drug Application (NDA) for accelerated approval of rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) 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.
Foundation Medicine, Clovis� companion diagnostic partner, has submitted a Premarket Approval (PMA) application for its FoundationFocus CDxBRCA to the FDA in June 2016. The test is designed to identify tumor BRCA mutations, including germline and somatic BRCA mutations. The timing of the submission is expected to allow for regulatory approval of the companion diagnostic in a similar timeframe.
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