Tesaro’s Ovarian Cancer Therapy Zejula Moves One Step Closer to EU Approval

Tesaro’s Ovarian Cancer Therapy Zejula Moves One Step Closer to EU Approval
The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Tesaro‘s Zejula (niraparib) as a maintenance therapy for recurrent platinum-sensitive ovarian cancer. The opinion was based on positive results from the Phase 3 ENGOT-OV16/NOVA study (NCT01847274), a randomized, double-blind, placebo-controlled trial evaluating the safety and effectiveness of Zejula maintenance

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