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FDA grants accelerated approval to Rubraca for advanced, BRCA–positive ovarian cancer
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The FDA granted accelerated approval to rucaparib for the treatment of women with advanced BRCA mutation–positive ovarian cancer who underwent at least two prior chemotherapy regimens.
Rucaparib (Rubraca, Clovis Oncology) is the first PARP inhibitor approved for this indication.
The ARIEL clinical development program included two multicenter, open-label, single-arm trials that evaluated rucaparib monotherapy in 106 patients with BRCA–mutated advanced ovarian cancer who had undergone at least two prior chemotherapy regimens.
Overall, 54% (95% CI, 44-64) of patients achieved complete or partial shrinkage of their tumors, and median duration of response was 9.2 months (95% CI, 6.6-11.6).
Common side effects in rucaparib-treated patients included nausea, fatigue, vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia and dyspnea.
Serious risks associated with drug use included myelodysplastic syndrome, acute myeloid leukemia and fetal harm.
“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, director of the office of hematology and oncology products in the FDA's Center for Drug Evaluation and Research and acting director of the FDA's Oncology Center of Excellence, said in a press release. “Women with these gene abnormalities who have tried at least two chemotherapy treatments for their ovarian cancer now have an additional treatment option.”
The FDA also approved the Foundation Focus CDxBRCA companion diagnostic (Foundation Medicine) for use with rucaparib. The test, the first FDA–approved next-generation sequencing–based companion diagnostic, detects the presence of BRCA gene mutations in the tumor tissue of women with ovarian cancer.