The Food and Drug Administration has granted accelerated approval to rucaparib for the treatment of women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a germline or somatic BRCA gene mutation. The FDA also approved the FoundationFocus CDxBRCA companion diagnostic for use with rucaparib to detect BRCA1 and BRCA2 gene mutations in the tumor tissue.

Approval of rucaparib (Rubraca), a poly ADP-ribose polymerase (PARP) inhibitor, was based on an objective response rate (ORR) of 54%, and a median duration of response of 9.2 months, in a pooled analysis of two, single-arm clinical trials, the FDA said in a statement .

All 106 patients in the two trials had BRCA-mutated advanced ovarian cancer and had been treated with two or more chemotherapy regimens. They received rucaparib 600 mg orally twice daily. BRCA gene mutations were confirmed in 96% of participants with available tumor tissue using the FoundationFocus CDxBRCA companion diagnostic. ORR was similar for patients with a BRCA1 gene mutation or BRCA2 gene mutation.

Safety was evaluated in 377 patients who received the drug and the most common adverse reactions were nausea, fatigue, vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea. Less common, but serious risks, include myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and fetal harm.

Patients should be monitored for hematologic toxicity at baseline and monthly thereafter, and use of rucaparib should be discontinued if MDS/AML is confirmed, the FDA said on its website .

Rucaparib is marketed by Clovis Oncology. The FoundationFocus CDxBRCA companion diagnostic is marketed by Foundation Medicine.

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