Updated: A week after GSK pulls one Zejula indication, FDA sets ODAC meeting to review revising label further
The FDA’s Oncologic Drugs Advisory Committee will meet on Nov. 22 to discuss whether to pull an indication for GSK’s ovarian cancer drug Zejula, considering the final overall survival data from the pivotal trial on which the approval was based.
ODAC will hear an update (the FDA press release at the time never mentions OS) on Zejula’s approval for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
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