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GSK To Restrict Second-line Maintenance Indication For Zejula In U.S.

GSK plc (GSK,GSK.L) said Friday that, at the request of the US Food and Drug Administration, it will restrict the second-line maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious germline BRCA mutations.

The company noted that 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.

The decision follows an FDA review of the final overall survival analysis of the ENGOT-OV16/NOVA phase III trial, which served as the basis for the approval of the second-line maintenance indication.

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