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 therapy in 553 patients with recurrent ovarian cancer who responded to prior platinum-based therapy. Participants were included in specific groups based on their BRCA mutation status, and randomly assigned Zejula or placebo. About two-thirds of the patients did not carry a BRCA mutation on their tumor. Results showed that Zejula significantly reduced the risk of disease progression or death. While the treatment worked particularly well among patients with a BRCA mutation, reducing the risk by 73 percent, those without BRCA mutations also saw their risk decrease by more than half (53 percent). The most common adverse effects were blood related: low platelets, low red blood cells, or low neutrophils count, but they were infrequent and well managed. “Zejula was studied with the highest level of clinical rigor, and the Phase 3 NOVA trial generated unsurpassed efficacy results in patients with recurrent ovarian cancer, including women without germline BRCA mutations who have the most challenging prognosis and few treatment options,” Mary Lynne Hedley, PhD, president and chief operating officer of Tesaro, said in a
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