EU approves Zejula as monotherapy in ovarian cancer

30 October 2020

Zejula (niraparib) has become the first PARP inhibitor to be approved as monotherapy in the European Union for certain people with platinum-responsive advanced ovarian cancer, regardless of biomarker status.

The decision comes several months after the US Food and Drug Administration granted approval in the same indication, broadening the label for the therapy based on data from the Phase III PRIMA study.

GlaxoSmithKline's (LSE: GSK) chief scientific officer Hal Barron said: “This approval of Zejula means that many more women will have the option to receive this innovative medicine earlier, potentially extending the time they may spend without their devastating cancer progressing.”

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