Lynparza (olaparib), the joint MSD and AstraZeneca cancer drug, has been granted an expansion by the National Institute for Health and Care Excellence (NICE) for maintenance treatment of certain cancers. The decision means that the PARP inhibitor is now the first and only of its kind in the UK to be approved in all lines of maintenance treatment.
The label extension now covers relapsed, platinum-sensitive high grade epithelial ovarian, fallopian tube or peritoneal cancer in adults whose disease has responded to platinum-based chemotherapy if they have a BRCA1 or BRCA2 mutation, meaning that the drug will be made available to patients within NHS England and Wales via routine commissioning if they have had three or more courses of platinum-based chemotherapy.
On top of this, it will be made available to patients within NHS England via the Cancer Drugs Fund (CDF) if they have had two courses of platinum-based chemotherapy.
The companies say that the decision was based on results of the SOLO2 trial, which showed a statistically-significant and clinically-meaningful improvement in progression-free survival (19.1 months vs. 5.5 months), with an estimated 43% of patients remaining progression-free at 24 months compared to 15% of patients in the placebo arm.
Before the extension decision, the drug was only available to relapsed BRCAm ovarian cancer patients if they have had three or more lines of chemotherapy, and even then they only had access to the capsule formulation – which is eight capsules twice daily. As of the decision, all patients with BRCAm ovarian cancer will have access to the tablet formulation (two tablets twice daily), regardless of their line of therapy.
In England, almost 60% of women with ovarian cancer are diagnosed with late stage disease, and even after surgery and chemotherapy, 70% will relapse within three years.