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Company Update (NASDAQ:CLVS): Clovis Oncology Inc Announces FDA Filing Acceptance of New Drug Application for Rucaparib for Priority Review

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Clovis Oncology Inc (NASDAQ:CLVS) announced that the U.S. Food and Drug Administration (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 lateJune 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.

“The acceptance of the rucaparib NDA submission represents an important milestone for rucaparib, and for Clovis,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “There is tremendous need for additional therapeutic options for patients with advanced mutant BRCA ovarian cancer and we look forward to cooperating with FDA on the rucaparib NDA review.”

“Recurrent ovarian cancer remains a very difficult disease to treat...


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