Tesaro, Inc. has opened an expanded access program (EAP) in the United States to make niraparib, an investigational poly (ADP-ribose) polymerase (PARP) inhibitor, available to eligible women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following a complete or partial response to platinum-based chemotherapy.1
EAPs allow patients with a serious or life-threatening disease or condition who are not otherwise eligible to participate in a clinical trial and have no other comparable or satisfactory therapeutic options to access investigational medicines.
US-based health care professionals seeking more information about the niraparib EAP can call Idis Managed Access at 1-877-768-4303 or email niraparibUSEAP@clinigengroup.com for further details about niraparib accessibility for eligible patients.
Niraparib is an oral, once-daily PARP inhibitor that being evaluated in 3 pivotal trials, including the phase 3 PRIMA trial for women with advanced ovarian cancer who responded to frontline platinum-based chemotherapy (ClinicalTrials.gov Identifier: NCT02655016), the phase 2 QUADRA trial for patients with recurrent ovarian cancer (ClinicalTrials.gov Identifier: NCT02354586), and the phase 3 BRAVO trial for patients with germline BRCA-mutant metastatic breast cancer (ClinicalTrials.gov Identifier: NCT01905592). Researchers are also assessing niraparib in various combination trials of niraparib plus immunotherapies such as pembrolizumab and bevacizumab.
The U.S. Food and Drug Administration has accepted a New Drug Application for priority review for niraparib based on data from the international, double-blind, phase 3 ENGO-OV16/NOVA trial (ClinicalTrials.gov Identifier: NCT01847274).
- Tesaro announces opening of niraparib expanded access program for U.S. patients with ovarian cancer. Tesaro website. http://ir.tesarobio.com/releasedetail.cfm?ReleaseID=1008099. Published January 17, 2017. Accessed January 17, 2017.