FDA Approves Clovis Oncology’s Rubraca for Prostate Cancer

The FDA has granted accelerated approval to Clovis Oncology’s Rubraca for patients with BRCA mutation-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

The approval was based on positive results from a phase 2 study. The company must verify the clinical benefit in confirmatory trials.

Rubraca is currently approved for ovarian, fallopian tube and peritoneal cancers that have been treated with two or more chemotherapies.