Clinigen begins US Managed Access program for TESARO’s niraparib in ovarian cancer patients

Niraparib is being made available for eligible women in the U.S. with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following a complete or partial response to platinum-based chemotherapy.

Approximately 22,000 women are diagnosed each year with ovarian cancer in the U.S. Despite high response rates to platinum-based chemotherapy, 85% of women with advanced ovarian cancer will recur after first line treatment, at which point, the disease is treatable but incurable.

Most patients who recur after first or second line therapy are treated with a further round of platinum-based chemotherapy, if they responded to the previous one.

However most do not receive any type of treatment post-response to the platinum-based treatment regimen and must watch and wait for the inevitable recurrence. Unfortunately, the efficacy of chemotherapy diminishes over time and most women will recur again quickly.

Niraparib is an oral, once-daily PARP 1/2 inhibitor. It is administered following a response to platinum-based chemotherapy which may address the difficult “watchful waiting” periods experienced by patients with recurrent ovarian cancer after the completion of chemotherapy, in between cycles of platinum-based chemotherapy.

Niraparib has been accepted for priority review by the U.S. Food and Drug Administration.

The Managed Access program allows physicians to request niraparib for individual, eligible U.S. patients who may not be able to participate in a clinical trial nor have any other treatment option, but who may benefit from access to this investigational therapy prior to approval.

Clinigen North America and Europe chief commercial officer Steve Glass said: “As the global leader in providing access to unlicensed medicines, we have delivered over 220 Managed Access programs which have benefited thousands of patients.

“There is a clear area of unmet medical need in the treatment of ovarian cancer, the fifth most common cause of death from cancer among women in the U.S. We are pleased to be partnering with TESARO to deliver this Managed Access program for niraparib, providing women with the opportunity to gain access to this important investigational therapy at the earliest possible moment.”