The second-line application of a GSK cancer treatment will be limited following a request by the US regulators, the drugs giant said on Friday.
The first-line application of Zejula – a maintenance treatment for ovarian, fallopian tube and peritoneal cancer for patients who have had a response to platinum-based chemotherapy – remains unchanged, however.
London-listed GSK said the US Food and Drug Administration had requested that the second line application be restricted to specific patients only, those with deleterious or suspected deleterious germline BRCA mutations.
The decision followed a review by the FDA of the final overall survival data from a phase III trial of Zejula.
Zejula is an oral, once-daily PARP inhibitor which is currently being evaluated across multiple trials. “GSK is building a robust clinical development programme by assessing activity across multiple tumour types and evaluating several potential combinations of Zejula with other therapeutics,” the blue chip noted.
