Niraparib (Zejula, GlaxoSmithKline) has been approved by the National Institute for Excellence in Health and Care (NICE) for the UK Cancer Drugs Fund (CDF) for some women with advanced ovarian cancer.
The decision means the drug should also be available in Wales and Northern Ireland. Scotland has not yet made its decision.
The PARP inhibitor will be available to women with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer stage 3 or 4 regardless of BRCA status after responding to first-line platinum-based chemotherapy.
NICE made its decision based on evidence from the ongoing PRIMA clinical trial.
The median progression-free survival for PRIMA was 13.8 months with niraparib and 8.2 months with placebo
It is not yet known whether the treatment will prolong life.
List price is £ 4,500 for 56 100 mg capsules before NHS confidential discounts.
According to NICE, the drug was made available on the CDF rather than for routine use due to clinical uncertainty about cost-effectiveness.
Target Ovarian Cancer charity has called the drug “breakthrough,” and its executive director Annwen Jones said in a statement, “Today’s announcement marks a major milestone in the fight against ovarian cancer. Unfortunately, two-thirds of women diagnosed later stage disease is absolute It is crucial that more effective treatments are available.
“This is the biggest breakthrough in ovarian cancer drugs since the introduction of the chemotherapy drug paclitaxel – taxol – in the 1990s.”