The National Institute of Health and Care Excellence (NICE) has recommended the use of Zejula (niraparib) as a maintenance therapy for people with advanced ovarian, fallopian tube, or primary peritoneal cancer.
The medication will be available through the Cancer Drugs Fund (CDF), a funding program that seeks to increase access to promising cancer medicines in England for patients with or without BRCA-mutated tumors who are responding to their initial round of platinum-based chemotherapy.
NICE’s recommendation might also benefit patients living in Wales and Northern Ireland, since decisions made in England are usually adopted in these two U.K. nations. Scotland, however, has a separate and unique process of reviewing therapies.
“This decision is great news that will be welcomed by people with this type of cancer,” Kruti Shrotri, head of policy development at Cancer Research U.K., said in a press release. “For many, monitoring is the only option available after chemotherapy, which can leave people feeling like they are waiting for their cancer to come back.”
Zejula is an oral PARP inhibitor marketed by Tesaro, a subsidiary of GlaxoSmithKline. It works by blocking enzymes that are needed for DNA repair, preventing tumor cells from repairing their DNA, and ultimately destroying them.
Because of its mechanism of action, Zejula and other PARP inhibitors tend to be more effective in patients whose tumors contain mutations in DNA repair genes, including BRCA genes.
Zejula was first approved in the U.S. and the EU as a maintenance therapy for people with recurrent ovarian cancer, who responded at least partly to platinum-based chemo.
Last year, Zejula was approved in the U.S. and the EU as a first-line maintenance therapy for patients with advanced ovarian cancer, including those with or without BRCA tumor mutations, who previously responded to platinum-based chemo.
These recent approvals were based on data from the PRIMA Phase 3 trial (NCT02655016), which demonstrated Zejula was superior to a placebo at prolonging the time patients lived without disease worsening (median of 13.8 vs. 8.2 months), lowering the risk of disease worsening or death by 38%.
These benefits were even stronger among patients whose tumors contained BRCA mutations, who lived a median of 21.9 months without disease worsening when offered Zejula, compared with 10.4 months for those on a placebo. In this subset of patients, Zejula reduced the risk of disease progression or death by 57%.
To date, PRIMA investigators have not been able to determine if Zejula also extends survival in these patients. The study must advance further before the therapy’s long-term benefits become clear.
Until then, and while uncertainties on long-term benefits remain, Zejula will not be recommended as a routine cancer therapy to be included in the U.K.’s National Health System. Yet, its potential to be a cost-effective therapy was sufficient to allow Zejula to be part of the CDF.
“Evidence from clinical trials suggests that niraparib can delay the progression of someone’s cancer, potentially delaying the need for more chemotherapy and improving their quality of life,” Shrotri said. “Because niraparib has been approved for use through the Cancer Drugs Fund, people will have access whilst more evidence on its longer-term benefits is gathered.”