On May 11, 2017 TESARO Inc. (NASDAQ:TSRO) and Clinigen Group plc’s (AIM:CLIN) (‘Clinigen’) Idis Managed Access division reported that they have partnered to launch a Managed Access Program (also known as an Early Access Program) in Europe for the investigational PARP 1/2 inhibitor, niraparib, for patients with recurrent ovarian cancer (Press release, TESARO, MAY 11, 2017, View Source [SID1234519052]). Schedule your 30 min Free 1stOncology Demo! Niraparib is currently an investigational agent in Europe and as such has not been granted approval by the European Commission. The niraparib marketing authorization application is under review by the European Medicines Agency.
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Niraparib was recently approved by the United States (U.S.) Food and Drug Administration under the brand name ZEJULA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Approximately 65,000 women are diagnosed with ovarian cancer in Europe every year. Ovarian cancer is the fifth-most frequent cause of cancer death among women. Despite high initial response rates to platinum-based chemotherapy, 85% of women with advanced ovarian cancer will see a recurrence of the disease after first line treatment. The efficacy of chemotherapy also diminishes over time.
Steve Glass, Chief Commercial Officer, North America and Europe for Clinigen said, "Following the successful delivery of the niraparib Managed Access Program in the US, we are pleased to be partnering with TESARO once again, providing eligible women in Europe the opportunity to gain access to this important investigational therapy."
Martin Huber, M.D., Senior Vice President, Chief Medical Officer for TESARO said, "We are proud to partner with Clinigen on this important Managed Access Program for women bravely facing ovarian cancer. The team at Clinigen has proven to be a partner of choice for TESARO as we look to address the needs of the ovarian cancer community."
About Niraparib
In Europe, niraparib is an investigational oral, once-daily poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, niraparib concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.