GSK cancer drug Zejula to face renewed FDA scrutiny during November adcomm

Shortly after GSK disclosed (PDF) to physicians that it had "voluntarily withdrawn" one Zejula indication, the FDA has published notice of an advisory committee meeting to review another approved use for the drug.

During a November meeting, the FDA's Oncologic Drugs Advisory Committee (ODAC) will review (PDF) data on the PARP inhibitor when it's used as a maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers who are in complete or partial response to platinum-based chemotherapy. Zejula won an FDA approval in this setting back in 2017.

Part of the ODAC review will center on final overall survival data from the NOVA trial, the Federal Register notice says. When the drug won its FDA nod, the agency highlighted an improvement in progression-free survival associated with Zejula in the trial, but it didn't mention overall survival, Endpoints News pointed out

With new data in hand, the "committee will consider whether the indication should remain in the U.S. labeling," the notice says.

Apart from this use, GSK last week wrote to doctors that it had pulled the fourth-line indication for Zejula in recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers. In doing so, GSK noted that it made the decision in consultation with the FDA.

The decision was based on the "totality of information” from PARP inhibitors in the late-line treatment setting for ovarian cancer, GSK said, citing two trials that observed a “potential detrimental” effect on overall survival with other PARP inhibitors.  

GSK has made oncology an area of focus in recent years, but its efforts haven't always panned out. Last year, SVB Leerink analyst Geoffrey Porges said the company’s five-year road map was already possibly in jeopardy thanks to setbacks for bintrafusp alfa and dostarlimab, two of its top prospects. At the time, Porges wrote that "serial disappointments are becoming a major concern for GSK’s medium- and long-term outlook."

The advisory committee meeting to discuss Zejula is slated for Nov. 22. GSK bought the drug through its 2019 acquisition of Tesaro.