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Pharmaceuticals / Submissions and Approvals

FDA Fast Tracks Glaxo’s Late-Stage Ovarian Cancer Candidate

July 8, 2019
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Federal regulators have agreed to fast-track review for GlaxoSmithKline subsidiary Tesaro’s late-stage ovarian cancer treatment Zejula (niraparib).

Zejula, a once-daily tablet, is currently in three pivotal trials, but Tesaro officials are optimistic that data from the Phase 2 QUADRA study will convince regulators to approve their application to treat women with ovarian, fallopian tube or primary peritoneal cancer who’ve already undergone three different treatments.

The FDA’s response to the application is due on Oct. 24.

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