We recognize that some patients with serious or immediately life-threatening disease may not be eligible for any of our clinical trials nor have other treatment options. In these cases, TESARO may provide access to niraparib outside of the clinical trials process, before it has been approved by the FDA, through an expanded access program (EAP).
Through TESARO's EAP, niraparib is being made available for eligible women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer following a complete or partial response to platinum-based chemotherapy for whom niraparib is considered an appropriate therapy. This EAP is being administered on behalf of TESARO by the Idis Managed Access division of Clinigen Group plc.
- For U.S.-based Physicians: Physicians 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. These channels are specifically for U.S.-based doctors who may have eligible patients.
- For U.S.-based Patients: If you are a patient interested in participating in the niraparib EAP, you should speak with your physician to understand if niraparib is an appropriate treatment option for you. All requests for access to niraparib through the niraparib EAP must come through a treating physician.
Access to Niraparib Outside of the U.S.
Patients should always discuss their treatment options with their physician.
Niraparib is currently being evaluated in a comprehensive, international clinical development program that includes TESARO-sponsored and investigator-initiated research in ovarian cancer and other cancers. Patients or physicians seeking more information about local niraparib clinical trial options can visit www.clinicaltrials.gov. TESARO plans to expand the niraparib EAP to include countries in Europe during the first half of 2017.
TESARO has established a comprehensive development program to evaluate the safety and efficacy of niraparib in patients with ovarian and breast cancer. This includes the QUADRA and PRIMA trials in ovarian cancer, and the BRAVO trial in breast cancer, which are currently enrolling patients. A number of investigator-led trials of nirapraib are also ongoing. For more information about ongoing clinical trials of niraparib, please visit www.clinicaltrials.gov.
Click here to for our frequently asked questions and answers regarding the niraparib EAP.