Ovarian, fallopian tube, or primary peritoneal cancer | News | Media | Blogs | iPharmaCenter

November 11, 2022

FDA restricted Zejula only to a patient population with deleterious or suspected deleterious germline BRCA mutations.

GSK announced that the US Food and Drug Administration restricted Zejula only to patients with deleterious or suspected deleterious germline BRCA mutations. The restriction is only for second-line patients, and there was no change in the first-line setting. Zejula is approved for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy.

The restriction was based on the NOVA phase III trial's overall survival (OS) data; the hazard ratio was 1.06 in the non-gBRCAmut cohort. NOVA was a placebo-controlled Phase 3 trial that evaluated Zejula in women with platinum-sensitive ovarian cancer. Progression-free survival was the primary endpoint, and overall survival was a secondary endpoint.

Zejula was a poly (ADP-ribose) polymerase (PARP) inhibitor approved for epithelial ovarian, fallopian tube or primary peritoneal cancer.

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