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FDA Grants Breakthrough Therapy Designation to Clovis Oncology’s Rubraca for BRCA1/2-Mutated Metastatic Castration Resistant Prostate Cancer

14:23 EDT 3 Oct 2018 | Speciality Pharma Journal

BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Rubraca® (rucaparib) as a monotherapy treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy. Breakthrough Therapy designation is granted by the FDA to investigational …

Original Article: FDA Grants Breakthrough Therapy Designation to Clovis Oncology’s Rubraca for BRCA1/2-Mutated Metastatic Castration Resistant Prostate Cancer

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