FDA Accepts GSKs sNDA for Zejula for FirstLine Maintenance Treatment of PlatinumResponsive Advanced Ovarian Cancer

FDA Accepts GSK’s sNDA for Zejula for First-Line Maintenance Treatment of Platinum-Responsive Advanced Ovarian Cancer

16:21 EST 24 Feb 2020 | Speciality Pharma Journal

GlaxoSmithKline plc today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s submission of a supplemental New Drug Application (sNDA) seeking approval of Zejula (niraparib) 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. The FDA is reviewing …

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