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

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Stocks fluctuated in morning trading on Friday before once again coming under pressure over the course of the afternoon. The major averages extended the sharp pullback seen on Thursday, ending the session at their lowest closing levels since late 2020. Consumer sentiment in the U.S. improved by less than initially estimated in the month of September, according to revised data released by the University of Michigan on Friday. The University of Michigan said the consumer sentiment index for September was downwardly revised to 58.6 from the preliminary estimate of 59.5. Chicago-area business activity unexpectedly contracted in the month of September, according to a report released by MNI Indicators on Friday. MNI Indicators said its Chicago business barometer slumped to 45.7 in September from 52.2 in August, with a reading below 50 indicating contraction. Economists had expected the business barometer to edge down to 51.8.
Follow RTT