Niraparib Expanded Access Program Opened for Women With Ovarian Cancer
Tesaro has opened an EAP to make niraparib available to eligible women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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.
RELATED: FDA Approves Rucaparib for BRCA-positive Ovarian Cancer
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.