NICE approves rucaparib as maintenance treatment for gynaecological cancer


  • Dawn O'Shea
  • Oncology drug update
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New NICE guidance recommends rucaparib for use within the Cancer Drugs Fund as an option for maintenance treatment of relapsed platinum-sensitive high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer that has responded to platinum-based chemotherapy.

The new guidance is based on a review of data from the ARIEL3 clinical trial, which demonstrated a statistically significant improvement in median progression-free survival (PFS) for the overall intention to treat (ITT) population with rucaparib compared to placebo (10.8 months vs 5.4 months; hazard ratio [HR] 0.36; 95% 0.30-0.45).

Overall-survival (OS) data are immature but rucaparib is expected to show an OS benefit similar to that seen with other PARP inhibitors. At data cut-off, 88% of patients were still alive. Median OS was not reached and no statistically significant difference between the treatment arms had been seen.

The NICE appraisal committee concluded that rucaparib increases PFS compared with routine surveillance but pointed out that the benefit in OS is uncertain because mature data are not yet available from the trial. Because of the uncertainty about the OS benefit, the estimates of cost effectiveness are also uncertain. NICE has not approved the treatment for routine use in the NHS but acknowledged that rucaparib has the potential to be cost-effective if mature OS data from ARIEL3 support the current estimates. It approved rucaparib for use within the Cancer Drugs Fund while more mature data is collected.