GSK pulls another cancer indication for Zejula at FDA's request
GSK said Friday morning that, at the request of the FDA, it will restrict the second-line maintenance indication for Zejula (niraparib) to only certain cancer patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut).
The move comes as the FDA recently announced and then canceled an ODAC meeting for later this month to review this indication.
GSK said in a statement that the decision is based on the FDA’s review of the final overall survival analysis of the Phase III trial that led to this approval in the second-line maintenance indication for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. In the final results from the trial, the secondary endpoint of OS demonstrated a hazard ratio (HR) of 1.06 (95% CI: 0.81-1.37) in the non-gBRCAmut cohort.
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