European Medicines Agency accepts submission of GSK's Marketing Authorisation Application for Zejula (niraparib) in first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer
Feb 27, 2020 - PR Newswire
PR Newswire
- Submission based on data from the Phase III PRIMA clinical study that demonstrated clinically meaningful outcomes of niraparib maintenance treatment in the first-line setting regardless of biomarker status
GlaxoSmithKline plc announced that the European Medicines Agency (EMA) has validated the company's Type II Variation (T2V) for Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum...
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