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NICE approves niraparib for ovarian, fallopian tube and peritoneal cancer

The National Institute for Health and Care Excellence (NICE) has approved niraparib for use within the Cancer Drugs Fund as a treatment option for 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. Niraparib is only approved for patients who are BRCA mutation-positive and have had 2 courses of platinum-based chemotherapy or are BRCA mutation-negative and have had at least 2 courses of platinum-based chemotherapy.

The decision is based on data from the double-blind randomised placebo-controlled NOVA trial, which showed that niraparib extended PFS compared with routine surveillance. The median PFS in people without a germline BRCA mutation was 9.3 months with niraparib and 3.9 months with placebo. For mutation-positive patients, median PFS was 21 months with niraparib and 5.5 months with placebo.

However, NICE pointed out that the final results on OS are not available yet. The committee concluded that there is no reason to suppose that the OS benefit will be less than the PFS benefit, but it is uncertain whether the benefit will be equal to or exceed that seen for PFS.

“Because of the uncertainty in the clinical evidence, the estimates of cost effectiveness are very uncertain. Therefore, niraparib cannot be recommended for routine use in the NHS,” NICE concluded.


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