Niraparib Approved for Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Approval was based on findings from the phase 3 NOVA trial, the results of which were published in The New England Journal of Medicine.
Approval was based on findings from the phase 3 NOVA trial, the results of which were published in The New England Journal of Medicine.

Niraparib was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with “recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy,” according to a release.1

Approval was based on findings from the phase 3 NOVA trial (ClinicalTrials.gov Identifier: NCT01847274), the results of which were published in The New England Journal of Medicine in December 2016.2

Five hundred and fifty-three patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal disease were randomized 2:1 to receive niraparib or placebo. The patients were also assigned to 1 of 3 cohorts depending on BRCA status.

Patients with a germline BRCA mutation receiving niraparib had an estimated median progression-free survival of 21 months vs 5.5 months for those who received a placebo. Those without this mutation who received niraparib had a progression-free survival of 9.3 months vs 3.9 months for those who received placebo.

Overall survival data were not mature at the time of analysis, though 60 of 372 patients in the niraparib group and 35 of 181 patients in the placebo group had died when the study databases were locked.

Grade 3-4 hypertension occurred among 9% of patients receiving niraparib vs 2% receiving placebo.

For dosage information, visit the FDA page.

RELATED: Hypermethylation of DNA Repair Genes in Ovarian Carcinoma

Niraparib is a selective inhibitor of poly(adenosine diphosphate [ADP]–ribose) polymerase (PARP) proteins.

References

  1. Niraparib (ZEJULA) [news release]. Silver Spring, MD: U.S. Food and Drug Administration; March 27, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ ApprovedDrugs/ucm548487.htm. Accessed March 28, 2017.
  2. Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-64.

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