TESARO, Inc has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the Company’s marketing authorisation application (MAA) for Zejula® (niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete response (CR) or partial response (PR) to platinum-based chemotherapy.
This opinion will now be referred to the European Commission (EC), which grants marketing authorisation for medicines in the European Union. Pending the decision by the EC, niraparib would be the first oral, once-daily poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor approved in Europe for use in patients regardless of BRCA mutation or biomarker status.
“Zejula was studied with the highest level of clinical rigour, and the Phase III 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,” said Mary Lynne Hedley, PhD, President and COO of TESARO. “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.”
The niraparib MAA is supported by data from the ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled, international Phase III study of niraparib that enrolled 553 patients with recurrent ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy.1 Approximately two-thirds of study participants did not have germline BRCA mutations. Progression in the NOVA study was determined by robust, unbiased, blinded central review to be the earlier of radiographic or clinical progression. Niraparib significantly increased progression free survival (PFS) in patients with and without germline BRCA mutations as compared to the control arm. Treatment with niraparib reduced the risk of disease progression or death by 73% in patients with germline BRCA mutations (HR 0.27) and by 55% in patients without germline BRCA mutations (HR 0.45). The magnitude of benefit was similar for patients entering the trial with a PR or a CR.
The most common grade 3/4 adverse reactions to niraparib in the NOVA trial included thrombocytopenia (34%), anaemia (25%), neutropenia (20%), and hypertension (9%).1 Following dose adjustment based on individual tolerability, the incidence of grade 3/4 thrombocytopenia was low; approximately 1% after month two.1 The majority of haematologic adverse events were successfully managed via dose modification, and discontinuation of therapy due to thrombocytopenia, neutropenia and anaemia occurred in 3.3%, 1.9% and 1.4% of patients, respectively.
“This is an important milestone for TESARO, marking our second positive CHMP opinion for our portfolio in 2017. We are rapidly globalising the Company’s mission of providing transformative oncology therapies to those who need them most,” said Orlando Oliveira, Senior Vice President and General Manager of TESARO International. “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.”
- Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med 2016. 375: 2154–2164.