GSK : FDA Panel To Review Zejula Data From Phase III Trial In Recurrent Ovarian Cancer

(RTTNews) - GSK plc (GSK, GSK.L) said that the US Food and Drug Administration will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss overall survival data from the ENGOT-OV16/NOVA phase III clinical trial in recurrent ovarian cancer.

NOVA is a randomised, double-blind, placebo-controlled phase III trial of Zejula (niraparib), an oral, once-daily poly polymerase inhibitor for the maintenance treatment of women with platinum-sensitive recurrent ovarian cancer.

The ODAC meeting is scheduled for 22 November 2022. This is not related to the niraparib indication in the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.