China Reviewing Zejula as First-line Therapy for Ovarian Cancer

China Reviewing Zejula as First-line Therapy for Ovarian Cancer
The Chinese regulatory agency has agreed to review Zai Lab's application asking that Zejula (niraparib) be approved as first-line maintenance therapy for women with ovarian cancer who are responding to platinum-based chemotherapy, the company announced. The supplemental New Drug Application (sNDA), submitted to the China National Medical Products Administration (NMPA), is for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. It follows a similar request for Zejula as a first-line treatment for these patients, made to the U.S. Food and Drug Administration in February by GlaxoSmithKline (GSK) and taken under review. “The NMPA’s acceptance of our sNDA submission for Zejula as a first-line monotherapy treatment after surgery and platinum-based chemotherapy has the potential to both fundamentally change how women with ovarian cancer are treated in China and significantly expand Zejula's market opportunity,” Samantha Du, founder and chief executive officer of Zai Lab, said in a
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