At the request of the US Food and Drug Administration (FDA), GlaxoSmithKline is restricting the use of Zejula® (niraparib) as second-line maintenance treatment in adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Now, niraparib can only be used in these patients if they have deleterious or suspected deleterious germline BRCA mutations (gBRCAmut).
The decision to restrict the indication follows an FDA review of the double-blind, phase 3 ENGOT-OV16/NOVA trial (ClinicalTrials.gov Identifier: NCT01847274), which was designed to compare the efficacy and safety of niraparib to placebo for the maintenance treatment of women with platinum-sensitive, recurrent ovarian cancer. The cohort included 203 patients with deleterious or suspected deleterious gBRCAmut and 350 patients without gBRCAmut.
The results showed a progression-free survival improvement with niraparib vs placebo, regardless of gBRCAmut status or homologous recombination deficiency (HRD) status.
However, the final overall survival (OS) analysis showed that the OS benefit with niraparib was limited to the gBRCAmut cohort. In this group, the median OS was 40.9 months for niraparib-treated patients and 38.1 months for patients on placebo (hazard ratio [HR], 0.85; 95% CI, 0.61-1.20).
In the non-gBRCAmut cohort, the median OS was 31 months for the niraparib arm and 34.8 months for the placebo arm (HR, 1.06; 95% CI, 0.81-1.37). In the non-gBRCAmut/HRD-positive subgroup, the median OS was 35.6 months for the niraparib arm and 41.4 months for the placebo arm (HR, 1.29; 95% CI, 0.85-1.95).
In a letter to health care providers, GlaxoSmithKline is advising prescribers not to initiate new treatment with Zejula for maintenance treatment of patients with non-gBRCAmut, platinum-sensitive, recurrent high grade serious epithelial ovarian, fallopian tube, or primary peritoneal cancer in the second- or later-line setting.
For patients already receiving treatment for this indication, an individual benefit-risk assessment should be conducted so that an informed decision regarding ongoing care can be made.
The first-line indication for Zejula for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy remains unchanged.
GlaxoSmithKline is currently working with the FDA on the revisions to the prescribing information for Zejula to reflect the restriction.
- GSK provides an update on Zejula (niraparib) US prescribing information. News release. GSK plc. November 11, 2022. Accessed November 15, 2022. https://www.gsk.com/en-gb/media/press-releases/gsk-provides-an-update-on-zejula-niraparib-us-prescribing-information/
- Zejula. Package insert. GSK plc; 2022. Accessed November 15, 2022. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Zejula_Capsules/pdf/ZEJULA-CAPSULES-PI-PIL.PDF
- Dear Health Care Provider Letter (Niraparib). GSK plc. Accessed November 15, 2022. https://www.zejulahcp.com/content/dam/cf-pharma/hcp-zejulahcp-v2/en_US/pdf/ZEJULA%20(niraparib)%20Dear%20HCP%20Letter%20November%202022.pdf
This article originally appeared on MPR