GSK wins speedy FDA Zejula review in ovarian cancer niche
fiercepharma | June 24, 2019
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, the FDA expects to hand down a decision by October 24, and if Zejula can secure an approval, it'll be the only drug in its class of PARP inhibitors—a group that includes AstraZeneca and Merck's Lynparza as well as Clovis Oncology's Rubraca—that can tout the specific indication. While Lynparza and Rubraca are also approved for BRCA-positive patients who have had multiple rounds of chemo, they're not cleared for those with HRD. Zejula is an oral PARP inhibitor currently approved as a maintenance treatment for women with recurrent ovarian, fallopian tube, or primary peritoneal cancer whose cancer returns. In that market, its jockeying with both Lynparza and Rubraca for positioning. Pfizer also last year won an approval for Talzenna, a fourth PARP inhibitor, to treat patients with germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer.