Expanded Access Program to Make Niraparib Available to More U.S. Ovarian-cancer Patients

Expanded Access Program to Make Niraparib Available to More U.S. Ovarian-cancer Patients

Women with epithelial-ovarian, fallopian-tube, or primary-peritoneal cancer who are not eligible for niraparib clinical trials, and who lack alternative therapies, may obtain the treatment under the expanded access program (EAP) that TESARO has opened in the United States.

Under the program, those whose cancer recurred after a complete or partial response to platinum-based chemotherapy will gain access to the investigational PARP inhibitor.

Europe plans an EAP for niraparib in the first half of 2017. It will be initiated on a country-by-country basis.

“Ovarian cancer is the fifth most frequent cause of cancer death among women in the United States, yet there have been few advances in the treatment of ovarian cancer in over a decade,” Mary Lynne Hedley, PhD, president and COO of TESARO, said in a news release. “The niraparib EAP will provide a mechanism by which eligible women with ovarian cancer may benefit from access to this investigational therapy, which has been accepted for priority review by the U.S. FDA.”

Niraparib is an oral PARP inhibitor that focuses on cancer cells’ inability to repair DNA. It is being evaluated in three clinical trials:

  • The Phase 3 PRIMA trial (NCT02655016), which is assessing niraparib as a maintenance therapy for ovarian-cancer patients who responded to first-line platinum-based chemotherapy.
  • The Phase 2 QUADRA trial (NCT02354586), designed to evaluate niraparib in ovarian-cancer patients who received three or four previous chemotherapy treatments.
  • The Phase 3 BRAVO trial (NCT01905592), which is evaluating niraparib in patients with advanced or metastatic breast cancer who have BRCA mutations.

In addition, TESARO is evaluating niraparib in combination studies. One involves a combination of niraparib and Keytruda (pembrolizumab) in triple-negative breast cancer and ovarian cancer (NCT02657889). Another involves a combination of niraparib and Avastin (bevacizumab) in ovarian-cancer patients (NCT02354131).

The U.S. Food and Drug Administration has accepted niraparib’s new-therapy application for priority review based on data from the ENGOT-OV16/NOVA study (NCT01847274), which was recently presented at the European Society for Medical Oncology (ESMO) 2016 Congress. The therapy has yet to be approved by the FDA, European Medicines Agency, or other regulatory body.