AstraZeneca and MSD have announced that NICE has expanded its recommendation for Lynparza™ (olaparib) tablets for women with relapsed, BRCA-mutated, advanced ovarian cancer.
Olaparib is now recommended by the National Institute for Health and Care Excellence (NICE) for maintenance treatment of 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 (BRCAm).
It 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; and to patients within NHS England via the Cancer Drugs Fund (CDF) if they have had two courses of platinum-based chemotherapy.
The decision was based on the results of the SOLO2 trial, which showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for olaparib compared to placebo, improving the PFS to a median of 19.1 months vs. 5.5 months, respectively (HR 0.30 [95% Confidence Interval 0.22-0.41], p<0.0001). Of those receiving olaparib, an estimated 43% remained progression-free at 24 months compared to 15% of patients in the placebo arm.
Previously, olaparib was only available to relapsed BRCAm ovarian cancer patients if they have had three or more lines of chemotherapy, and they only had access to the capsule formulation (eight capsules twice daily). Today’s announcement means that all patients with BRCAm ovarian cancer have access to the tablet formulation (two tablets twice daily), regardless of their line of therapy.
Professor Jonathan Ledermann, Professor of Medical Oncology at the University College London Cancer Institute, said: “This decision is positive news for patients because it means that we now have access to olaparib tablets for BRCA-mutated ovarian cancer across all lines of therapy. Not only does this mean that we have an additional treatment option that offers significant clinical benefits to patients, it also means that all patients currently being treated with olaparib can now access the tablet formulation instead of the capsules.”
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. Every two hours a woman dies from ovarian cancer in the UK. Approximately 22% of ovarian cancer patients carry a BRCA mutation, which can be identified via genetic testing upon referral by a healthcare professional.
Mohit Manrao, Business Unit Director, Oncology at AstraZeneca UK said: “We are delighted to have reached an arrangement with NICE to enable expanded access to olaparib tablets as maintenance treatment for women with advanced ovarian cancer who have had two or more lines of chemotherapy. As a UK-based company, it’s great to see this product of British science become more widely available, therefore helping more women across England and Wales.”
The NICE recommendation
The Final Appraisal Document by NICE states that the recommendation is as follows:
Olaparib is recommended as an option for the maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose disease has responded to platinum-based chemotherapy only if:
- they have a BRCA1 or BRCA2 mutation
- they have had 3 or more courses of platinum-based chemotherapy and
- the company provides olaparib according to the commercial arrangement.
Olaparib is recommended for use within the Cancer Drugs Fund as an option for the maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose disease has responded to platinum-based chemotherapy only if:
- they have a BRCA1 or BRCA2 mutation
- they have had 2 courses of platinum-based chemotherapy and
- the conditions in the managed access agreement for olaparib are followed.