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GSK wins speedy FDA Zejula review in ovarian cancer niche

June 24, 2019 / Eric Sagonowsky

GlaxoSmithKline has been working to restrengthen in cancer, particularly through a multibillion-dollar purchase of Tesaro. The main drug from the buyout, Zejula, is now up for a priority review in late-stage ovarian cancer, where it's working to pick up a niche nod its rivals don't have. The FDA has accepted GSK's application for the drug to treat patients with advanced ovarian, fallopian tube or primary peritoneal cancer who have had at least three prior chemo regimens. The patients must also have a BRCA mutation or homologous recombination deficiency for their cancers, and in the case of HRD cancers, must have progressed at least half a year from their last chemo treatment. The application is based on data in a trial called Quadra that found “clinically relevant activity” for the patients when treated with the drug. Investigators noted that the patients have few options, and that survival after the third line of treatment ranges from 5 months to 9 months. Now,...