www.fdanews.com/articles/197185-fda-approves-clovis-oncologys-rubraca-for-prostate-cancer
FDA Approves Clovis Oncology’s Rubraca for Prostate Cancer
May 19, 2020
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.