GSK: FDA accepts filing for ovarian cancer drug Zejula
(CercleFinance.com) - GlaxoSmithKline said on Monday that the US Food and Drug Administration has accepted the filing of a new drug application for its ovarian cancer drug Zejula.
The FDA has accepted the company's submission of a supplemental application seeking approval of the drug as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status.
In the US, ovarian cancer impacts nearly 222,000 women annually, with 85% of them seeing their disease return.
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