European Medicines Agency Will Review Marketing Application for Niraparib to Treat Ovarian Cancer

European Medicines Agency Will Review Marketing Application for Niraparib to Treat Ovarian Cancer
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) of niraparib for the treatment of platinum-sensitive ovarian cancer patients, according to Tesaro, the product manufacturer. “Tesaro is committed to improving the lives of patients with cancer by responsible development and commercialization, and the validation of the niraparib MAA represents a significant milestone for the company,” Mary Lynne Hedley, PhD, president and chief operating officer of Tesaro, said in a news release. “We believe niraparib could become an important new treatment option for patients. We look forward to working with the EMA during the review process and expect to complete our rolling NDA [New Drug Application] submission to the FDA for niraparib imminently,” she said. Niraparib is an orally active inhibitor of the PARP family of proteins, which are involved in a variety of cellular mechanisms, including the repair of damage to the DNA molecules. PARP inhibitors have shown activity as a monotherapy in tumors bearing DNA repair defects, such as those with BRCA1 or BRCA2 mutations, or in combination with chemotherapy agents that induce DNA damage. The marketing application is based on data from the ENGOT-OV16/NOVA study (NCT01847274), a randomized, double-blind, Phase 3 trial evaluating the safety and effectiveness of niraparib compared to a placebo in 553 patients with recurrent ovarian cancer who responded to platinum-based therapy. The data,
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