Clovis Oncology announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to rucaparib, an oral potent PARP1 and PARP2 inhibitor, as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA (gBRCA) and somatic BRCA (sBRCA) mutations.

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The designation was based on interim efficacy and safety results from two ongoing Phase 2 studies of rucaparib in ovarian cancer, including a Phase 2 study in women with gBRCA butations, and the ARIEL2 treatment study. Recently presented results for ARIEL2 demonstrated that 70% (16/23) of the evaluable BRCA-mutant patients achieved a RECIST and/or CA-125 response, and 65% (15/23) achieved a RECIST response.

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