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 press release.
“Today’s positive CHMP opinion brings us one step closer to providing this important new medicine to a broad population of patients with recurrent ovarian cancer in Europe,” she said.
The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve new medicines for the European Union.
“Upon final approval by the EC, we intend to launch Zejula across multiple countries in Europe where we already have an established, direct presence, beginning in the fourth quarter,” said Orlando Oliveira, senior vice president and general manager of Tesaro International.
The U.S. Food and Drug Administration (FDA) approved Zejula as a maintenance therapy for recurrent ovarian cancer in March 2017.
Zejula is a PARP inhibitor and promotes cancer cell death by preventing proper repair of DNA damage. It has emerged as a promising therapy for ovarian cancer patients, with few severe side effects.
Lynparza (olaparib) is another PARP inhibitor approved for ovarian cancer, but Zejula would be the first PARP inhibitor approved in Europe for ovarian cancer regardless of BRCA mutational status.