FDA accepts Glaxo’s application for expanded use of Zejula

GlaxoSmithKline (NYSE:GSK) announces that the FDA has accepted under Priority Review TESARO’s supplemental marketing application seeking approval to use Zejula (niraparib) to treat adult patients with advanced ovarian, fallopian tube or primary peritoneal cancer who have received at least three prior lines of chemo, whose cancers are either BRCA-positive or homologous recombination deficiency-positive and have progressed more than six months after the most recent line of platinum-based chemo.

The agency’s action date is October 24.

The FDA approved Zejula in March 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemo.

Shares are up a fraction premarket.

https://seekingalpha.com/news/3473206-fda-accepts-glaxos-application-expanded-use-zejula