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Officials with the FDA approved niraparib (Zejula, GlaxoSmithKline), a once-daily, oral monotherapy, for the first-line maintenance treatment of platinum-responsive advanced ovarian cancer regardless of biomarker status.
Officials with the FDA approved niraparib (Zejula, GlaxoSmithKline), a once-daily, oral monotherapy, for the first-line maintenance treatment of platinum-responsive advanced ovarian cancer regardless of biomarker status, according to a press release.1
The supplemental New Drug Application was approved under the FDA’s Real-Time Oncology Review pilot program.1
Niraparib is the only once-daily poly ADP ribose polymerase inhibitor approved in the United States as monotherapy for this indication in the first-line and recurrent maintenance treatment settings, as well as late-line primary treatment settings, according to GSK.1
The approval was based on results from the phase 3 PRIMA study, in which niraparib significantly improved progression-free survival (PFS) for patients, regardless of biomarker status. Study results were previously published in The New England Journal of Medicine.1,2
For the study, patients received a fixed starting dose of 300 mg of niraparib once-daily; an individualized starting dose of either 200 mg or 300 mg was later incorporated based on the patient’s baseline weight and/or platelet count. Of the 733 patients in the trial, 50.9% had tumors with homologous recombination deficiency (HRd).2
According to the findings, patients in the HRd population who were treated with niraparib showed a 57% reduction in the risk of disease progression or death versus placebo in the overall population (hazard ratio [HR] -.42; 95% CI, 0.31 to 0.59; p<0.0001).2
In the overall population, the corresponding PFS was 13.8 months and 8.2 months (HR, 0.62; 95% CI, 0.50 to 0.76; P<0.001). At the 24-month interim analysis, the data showed that the rate of overall survival was 84% in the niraparib group and 77% in the placebo group (HR, 0.70; 95% CI, 0.44 to 1.11).2
Additionally, niraparib’s safety profile was consistent with clinical trial experience. The most common grade 3 or higher adverse events included thrombocytopenia (39%), anemia (31%), and neutropenia (21%).2
“PRIMA was designed for patients with ovarian cancer who have a high unmet need,” Bradley Monk, MD, FACOG, FACS, said in a statement.1 “The positive data observed regardless of biomarker status in this study is extremely encouraging and suggests benefit beyond the BRCAm population. This approval is an important step forward in the treatment of ovarian cancer. In my opinion, maintenance treatment with niraparib should be considered an option for appropriate patients who responded to first-line platinum-based chemotherapy versus active surveillance.”
1. FDA approves Zejula (niraparib) as the only once-daily PARP inhibitor in first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of biomarker status. News Release. GlaxoSmithKline; April 29, 2020. Accessed April 30, 2020.
2. GonzÃ¡lez-MartÃn A, Pothuri B, Vergote I, et al. Niraparib in patients with newly diagnosed advanced ovarian cancer. New England Journal of Medicine. Published December 19, 2019. Doi:10.1056/NEJMoa1910962