Clovis’s ovarian cancer drug wins accelerated FDA approval

(Reuters) - The U.S. Food and Drug Administration said on Monday it granted accelerated approval to Clovis Oncology Inc's ovarian cancer drug in patients whose disease advanced despite chemotherapy. The drug, Rubraca, secured approval for patients whose tumors have a specific gene mutation called BRCA - identified by an FDA-approved companion diagnostic test, the FDA said. When a drugmaker wins accelerated or conditional approval, it must provide further evidence of the drug's benefit to satisfy the regulator, failing which the approval can be revoked.