(Reuters) – Clovis Oncology Inc said on Friday the U.S. Food and Drug Administration has approved its drug Rubraca for the treatment of adult patients with metastatic castration-resistant prostate cancer, whose tumors have a genetic mutation.
The approval is for the drug’s use as monotherapy in patients whose tumors have a mutation called BRCA, and whose disease had advanced despite chemotherapy and hormone-directed therapy, the company said.
Rubraca, like GlaxoSmithKline Plc’s Zejula and AstraZeneca Plc and Merck & Co Inc’s Lynparza, belongs to a class of cancer drugs called PARP-inhibitors, which work by blocking enzymes involved in repairing damaged DNA of cancer cells, thereby helping to kill them.
The drug has already been approved in the United States 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.
Metastatic castration-resistant prostate cancer (mCRPC) is an advanced stage of the disease where the cancer has spread to other parts of the body and is usually associated with poor prognosis.
The American Cancer Society estimates that nearly 192,000 men in the United States will be diagnosed with prostate cancer in 2020, and about 43,000 of them are expected to be diagnosed with mCRPC.
About 12% of patients with mCRPC harbor a BRCA mutation, Clovis said.
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shailesh Kuber)