Rubraca is intended for advanced ovarian cancer patients with a BRCA gene mutation who have already been treated with two or more chemotherapies.
The FDA also approved on Monday a diagnostic test to identify the presence of BRCA gene mutations, which was designed to be used in tandem with Rubraca, according to the report.
The FDA’s Accelerated Approval Program allows for the earlier approval of drugs to fill an unmet clinical need, according to the agency’s website. The continued approval of Rubraca is contingent on the results of two clinical trials Clovis Oncology must conduct to confirm the drug’s efficacy.
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