European Commission Approves Tesaro’s Zejula as Maintenance Therapy for Ovarian Cancer

European Commission Approves Tesaro’s Zejula as Maintenance Therapy for Ovarian Cancer
The European Commission has approved Tesaro's Zejula (niraparib) as a maintenance treatment for ovarian cancer, with or without BCRA mutations, in women who have shown a complete or partial response to platinum-based chemotherapy. The treatment was approved as a stand-alone therapy for adult patients with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancers. This follows Zejula's approval in the U.S. for the same indication in March 2017. “With the introduction of Zejula, treatment of women with recurrent ovarian cancer will improve markedly,” Andreas Du Bois, MD, center director of gynecology and gynecologic oncology at Kliniken Essen-Mitte in Germany, and co-founder and past chair of the European Network of Gynecological Oncological Trial Groups (ENGOT), said in a press release. “Patients and their physicians are now empowered with an additional option to utilize after a response to chemotherapy, regardless of BRCA mutation status, where the previous alternative for most was a period of watching and waiting instead of actively controlling their disease.” The approvals were based on results from the Phase 3 ENGOT-OV16/NOVA trial (NCT01847274), which tested if Zejula was better than a placebo at delaying disease progression in ovarian cancer patients who had responded to platinum-based chemotherapy. The study enrolled 553 patients with recu
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