(Alliance News) - GSK PLC on Friday said it will restrict the use of its niraparib, sold under the brand name Zejula, to patients in the US.
Shares were down 4.1% at 1,350.00 pence each on Friday morning in London.
The London-based pharmaceutical firm said that at the request of the US Food and Drug Administration, it will only give the second-line applications of the drug to people with "deleterious or suspected deleterious germline BRCA mutations".
Germline mutations are present from birth in all cells in the body.
Zejula is used to treat recurrent ovarian, advanced epithelial ovarian, fallopian tube, and primary peritoneal cancers in patients who are in a complete or partial response to first-line platinum-based chemotherapy.
GSK said the US first-line indication of Zejula remains 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".
It said the decision follows an FDA review of the final overall survival analysis of the NOVA phase III trial.
In September, GSK said Zejula showed a long-term survival benefit in a phase III ovarian cancer study.
Back then it said homologous recombination deficient patients, who were treated with Zejula, were predicted to be more than twice as likely free of progression or death at four years compared to a placebo.
By Xindi Wei; xindiwei@alliancenews.com
Copyright 2022 Alliance News Limited. All Rights Reserved.
Glaxosmithkline (GSK)