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WASHINGTON -- The FDA today granted accelerated approval to the PARP inhibitor rucaparib (Rubraca) for previously treated, BRCA-mutant ovarian cancer.

The agency stipulated that the approval applies to women whose disease has relapsed or progressed after at least two prior chemotherapy regimens. Additionally, the cancer's BRCA status must be confirmed by a companion diagnostic test that the FDA approved at the same time.

"Today's approval is another example of the trend we are seeing in developing targeted agents to treat cancers caused by specific mutations in a patient's genes," Richard Pazdur, MD, the FDA's director of hematology and oncology products, said in a statement.

The FDA previously approved rucaparib for priority review. The agency's accelerated approval program allows approval of a drug on the basis of clinical data demonstrating an effect on a surrogate endpoint (clinical response, in the case of rucaparib) that likely correlates with clinical benefit. The agency retains the right to revoke the approval, pending the outcome of continued clinical evaluation of the drug.

Rucaparib received accelerated approval on the basis data from two single-arm clinical trials involving a total of 106 patients with advanced, previously treated, BRCA-mutant ovarian cancer. BRCA-mutant status was confirmed in 96% of cases by means of the companion diagnostic test, FoundationFocus CDxBRCA, a next-generation sequencing assay.

The results showed that 54% of patients attained a complete or partial response to rucaparib, and the responses persisted for a median duration of 9.2 months.

The most common side effects associated with rucaparib were nausea, fatigue, vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea. The only serious adverse event noted in the FDA's summary of the approval was myelodysplastic syndrome.

Rucaparib is the second PARP inhibitor approved in the United States, following olaparib (Lynparza), which received FDA approval in 2014 for BRCA-mutant ovarian cancer. The two agents could soon be joined by a third member of the PARP inhibitor class, niraparib. As reported at the European Society for Medical Oncology meeting, a placebo-controlled trial of niraparib demonstrated a 15.5-month improvement in progression-free survival in patients with recurrent, platinum-sensitive ovarian cancer, irrespective of BRCA status.

Rucaparib is marketed by Clovis Oncology of Boulder, Colo.

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