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).
Niraparib Access in the U.S.
Given the commercial availability of niraparib in the United States, the EAP is now closed to new enrollment for U.S. patients.
Niraparib EAP Outside the U.S.
TESARO offers an EAP for niraparib in Europe for patients who meet the program's inclusion criteria. European-based healthcare professionals can obtain details about the niraparib EAP at +44 1283 494 340 or by emailing firstname.lastname@example.org.
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 or www.clinicaltrialsregister.eu.
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, which are currently enrolling patients. Additional registrational studies in the settings of metastatic ovarian, breast and lung cancers are also planned. A number of investigator-led trials of niraparib are also ongoing. For more information about ongoing clinical trials of niraparib, please visit www.clinicaltrials.gov or www.clinicaltrialsregister.eu.
Click here to for our frequently asked questions and answers regarding the niraparib EAP.