FDA grants accelerated approval for new Rubraca indication

On Friday, the US Food and Drug Administration granted accelerated approval to Rubraca (rucaparib) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

Shares of the drug’s developer, Clovis Oncology (Nasdaq: CLVS), rose as much as 9.8% to $10.30 on the news, though closed only 2% higher.

Rubraca, which generated sales of $143 million in 2019 (up 50% year-on-year), has previously been approved in the USA as a maintenance treatment for adults with ovarian, fallopian tube, primary peritoneal cancers whose disease has come back and whose tumor has responded to a platinum-based chemotherapy.