Recurrent ovarian cancer patients in Europe with few or no treatment options may soon have access to an investigational therapy, niraparib, under a managed access program launched by Tesaro, the drug’s developer, and the British-based Clinigen Group.
The European Medicines Agency is considering recommending niraparib as a maintenance treatment for people with recurrent ovarian cancer and a complete or partial response to platinum-based chemotherapy, under a marketing authorization application request. Until that recommendation is made and approved by the European Commission, Tesaro is working to provide access to eligible patients. Managed access programs are for people with life-threatening diseases who are not able to take part in clinical trials and have limited, at best, treatment options.
“Following the successful delivery of the niraparib Managed Access Program in the US, we are pleased to be partnering with TESARO once again, providing eligible women in Europe the opportunity to gain access to this important investigational therapy,” Steve Glass, Clinigen’s chief commercial officer for North America and Europe, said in a press release.
The U.S. Food and Drug Administration approved niraparib, under the brand name Zejula, as a maintenance therapy for adult patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer in March. Tesaro also launched a managed access program in the U.S. in January for patients there whose cancer recurred following a complete or partial response to platinum-based chemotherapy, so they could gain access to the PARP inhibitor.
Some 65,000 women are diagnosed with ovarian cancer every year in Europe. Despite advances in ovarian cancer treatment, 85 percent of patients eventually relapse after first-line treatment, and subsequent responses to additional therapies are short-lasting.
Women with germline (inherited) BRCA mutations, however, seem to be particularly sensitive to PARP inhibitors like niraparib, and some studies have suggested that women without the mutations may also benefit from the therapy.
Tesaro is currently evaluating niraparib once daily in two Phase 3 studies. The PRIMA trial (NCT02655016) is assessing niraparib as a maintenance therapy for ovarian cancer patients who responded to first-line platinum-based chemotherapy. The BRAVO trial (NCT01905592) is evaluating niraparib in patients with advanced or metastatic breast cancer who have BRCA mutations.
“We are proud to partner with Clinigen on this important Managed Access Program for women bravely facing ovarian cancer,” Martin Huber, Tesaro’s senior vice president and chief medical officer, said. “The team at Clinigen has proven to be a partner of choice for TESARO as we look to address the needs of the ovarian cancer community.”
More information about the managed access program in Europe is available by calling +44 1283 494 340 or emailing firstname.lastname@example.org.