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, recently presented at the European Society for Medical Oncology (ESMO) 2016 Congress, showed that niraparib improved patients’ progression-free survival in both BRCA-positive tumors (21 months vs. 5.5 months) and in BRCA-negative tumors (9.3 months vs. 5.5 months), as well as their chemotherapy-free interval and overall survival.
In addition, the observed grade 3 and grade 4 adverse events, which included anemia, reduced platelet number, and reduced number of neutrophils (a type of immune cells), were all resolved upon dose adjustments. Similar quality of life outcomes were observed in the niraparib and control arms.
“The validation of our MAA for niraparib today marks an important step towards globalizing our mission of providing transformative therapies to people bravely facing cancer,” said Orlando Oliveira, senior vice president and general manager of Tesaro International. “With the MAA for oral rolapitant already under review by the EMA, we are well positioned for two potential product launches in Europe in 2017.”
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