TESARO, Inc. has completed its rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration for niraparib as maintenance treatment of patients with platinum-sensitive, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who responded to platinum-based chemotherapy.1
The NDA is based on findings from the international, double-blind, phase 3 ENGOT-OV16/NOVA trial (ClinicalTrials.gov Identifier: NCT01847274), which evaluated niraparib maintenance compared with placebo in 553 patients with recurrent ovarian cancer who responded to their most recent platinum-based chemotherapy.
Niraparib significantly reduced the risk of disease progression or death by 73% vs placebo (hazard ratio [HR], 0.27; 95% CI, 0.17-0.41), achieving the study’s primary end point. Progression-free survival benefit was observed regardless of the presence or absence of a BRCA mutation.
The indication proposed in the NDA provides for the use of niraparib irrespective of tumor biomarker status, with the BRACAnalysis CDx and myChoice Homologous Recombination Deficiency (HRD) tests available to physicians as complementary diagnostics.
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The oral, once-daily PARP inhibitor is also being evaluated as first-line treatment for ovarian cancer in the phase 3 PRIMA trial (ClinicalTrials.gov Identifier: NCT02655016), as treatment for ovarian cancer in the phase 2 QUADRA trial (ClinicalTrials.gov Identifier: NCT02354586), and as treatment for patients with germline BRCA-mutated, metastatic breast cancer in the phase 3 BRAVO trial (ClinicalTrials.gov Identifier: NCT01905592).
- TESARO announces submission of niraparib new drug application for platinum-sensitive, recurrent ovarian cancer. TESARO website. http://ir.tesarobio.com/releasedetail.cfm?ReleaseID=996821. Updated November 1, 2016. Accessed November 2, 2016.]