Tesaro has been asked by NICE to submit a proposal for Zejula use on the National Health Service via the Cancer Drugs Fund for maintenance treatment of patients with relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer.
The drug was approved by European regulators in November last year for patients in a complete response (CR) or partial response (PR) to platinum-based chemotherapy.
Zejula (niraparib) is the first once-daily, oral poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor to be cleared in the region for patients regardless of BRCA mutation status.
Platinum-based chemotherapy is an effective but its efficacy diminishes over time, and progression-free survival becomes shorter after each successive platinum treatment, highlighting the need for new treatment options.
According to Tesaro, Zejula provides an opportunity to increase progression-free survival after platinum therapy, which it says will have "a profound impact" on women and their families.
In clinical trials, the treatment was shown to cut the risk of disease progression or death by 73 percent in patients with germline BRCA mutations and by 55 percent in those without germline BRCA mutations, the firm noted.
However, in draft guidelines, the National Institute for Health and Care Excellence has concluded that despite being recognised as a promising treatment, there was not sufficient evidence of clinical and cost effectiveness for Zejula to be recommended for routine commissioning.
The drug’s inclusion in the CDF, however, would allow uncertainties in the clinical evidence to be addressed through the collection of additional data, it said.
As such, the company has been invited by NICE to submit a proposal for including Zejula in the CDF for treating relapsed, platinum-sensitive high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to the most recent course of platinum-based chemotherapy in adults, but only if patients have a germline BRCA mutation and have had two courses of platinum-based chemotherapy, or they do not have a germline BRCA mutation and have had two or more courses of platinum-based chemotherapy.