GSK Limits Ovarian Cancer Drug’s Indication
The FDA has asked GSK to restrict its second-line maintenance indication for its ovarian cancer drug Zejula (niraparib) to patients with deleterious or suspected deleterious germline BRCA mutations, maintaining approval for the drug’s first-line indication.
This decision comes just after the agency scheduled, then cancelled, an Oncologic Drugs Advisory Committee meeting in late November to review the second indication for Zejula.
GSK said the decision follows an FDA review of the final overall survival analysis of the phase 3 trial for the drug, which showed no risk reduction compared to the control treatment.
Zejula is still indicated for first-line maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.