Olaparib is now available for NHS patients in England and Wales with platinum-sensitive relapsed (PSR) BRCA-mutated (BRCAm) high-grade serous ovarian cancer who have had three or more courses of platinum-based chemotherapy.
The National Institute for Health and Care Excellence (NICE) issued Technology Appraisal Guidance (TAG) on 27 January 2016 recommending olaparib as a cost-effective post- chemotherapy maintenance treatment option for this patient group.
It is now over 90 days since the TAG was published, and Clinical Commissioning Groups, NHS England and local authorities are required to ensure that olaparib is funded and accessible to patients.
Professor Jonathan Ledermann, Professor of Medical Oncology at the University College London Cancer Institute and Primary Investigator of the pivotal olaparib clinical trial said “We have entered a new era for how women with ovarian cancer and a BRCA mutation are treated by the NHS in England and Wales. Until now, treatment options have been limited to conventional chemotherapy and surgery. It is important that clinical staff offer their patients with ovarian cancer a test for a BRCA mutation as soon as possible, to find out if olaparib is an appropriate treatment option for them."
Ovarian cancer is a serious and life-threatening condition that causes more than 4,000 women in the UK to die each year.
Up to 21% of women with the most aggressive form of ovarian cancer have the genetic BRCA mutation and it is this patient group for whom olaparib is licensed in Europe.
Testing for BRCA mutations is currently recommended by NICE in patients with a 10% or greater risk of carrying a BRCA mutation.
Olaparib is the first targeted therapy for women with BRCAm ovarian cancer and clinical trials show that it provides an important quality of life benefit by significantly increasing the time it takes for the disease to progress and the time to further chemotherapy cycles.
There was an 82% risk reduction in time to progression versus standard ‘watch and wait’, which is the largest ever effect for this outcome in women with ovarian cancer (HR 0.18, p<0.0001; median progression free survival, 11.2 months versus 4.3 months).
These data are for the overall population that olaparib is licensed for; data for the NICE- approved patient group are consistent with this.
To date, the most common side-effects experienced by patients taking olaparib were mild to moderate, in most cases did not cause the patient to stop taking treatment, and included nausea, fatigue, vomiting and anaemia.
Lisa Anson, Country President at AstraZeneca UK and Ireland, which markets olaparib as Lynparza, said “AstraZeneca is delighted that NHS patients in England and Wales will now have the opportunity to benefit from olaparib, a treatment that was discovered and developed with the support of the British science community. Patients with recurrent ovarian cancer often have a poor prognosis and so the introduction of a targeted treatment option for those with the BRCA mutation is great news for them.”