FDA Approval Summary: Niraparib for the maintenance treatment of patients with recurrent ovarian cancer in response to platinum-based chemotherapy

The Food and Drug Administration approved niraparib, a poly ADP ribose polymerase (PARP) inhibitor, on March 27, 2017, for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapy. Approval was based on data from the NOVA trial comparing niraparib with placebo in two independent cohorts, based on germline BRCA mutation status (gBRCAm vs. non-gBRCAm). Progression-free survival (PFS) in each cohort was the primary endpoint. In the gBRCAm cohort, estimated median PFS on niraparib was 21 months vs. 5.5 months on placebo (HR 0.26; 95% CI: 0.17, 0.41; p-value <0.0001). In the non-gBRCAm cohort, estimated median PFS for niraparib and placebo was 9.3 months and 3.9 months, respectively (HR 0.45; 95% CI: 0.34, 0.61; p<0.0001). Common adverse reactions (>20% and higher incidence in niraparib arm) with niraparib include thrombocytopenia, anemia, neutropenia, nausea, constipation, vomiting, mucositis, fatigue, decreased appetite, headache, insomnia, nasopharyngitis, dyspnea, rash, and hypertension. There were 5 cases of MDS/AML (1.4%) in patients treated with niraparib compared with 2 cases (1.1%) on placebo. Niraparib is the first PARP inhibitor approved as maintenance therapy for ovarian, fallopian tube, or primary peritoneal cancer patients, with improvement in PFS, for patients regardless of gBRCAm status.

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