By Anthony O. Goriainoff


GSK said Friday that it would only recommend its ovarian-cancer treatment Zejula as a secondary maintenance treatment to a subgroup of patients in the US who carry a specific genetic mutation connected to breast cancer, known as BRCA.

The London-listed pharmaceutical giant said this was at the request of the U.S. Food and Drug Administration. It added that the U.S. first-line indication remained unchanged for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy.

GSK said the decision followed a review by the FDA of the final overall survival analysis of the ENGOT-OV16/NOVA phase three trial which was used as the basis for the approval of the second-line maintenance indication.


Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com


(END) Dow Jones Newswires

11-11-22 0241ET