New era for women: NICE approves olaparib for ovarian cancer

NICE has approved olaparib for ovarian cancer in the Cancer Drugs Fund, heralding a new era for women with ovarian cancer.

NICE has approved olaparib for ovarian cancer in the Cancer Drugs Fund, heralding a new era for women with ovarian cancer.

AstraZeneca and MSD’s Lynparza (olaparib) has previously been used at a later stage in the treatment of advanced ovarian cancer, now it has been approved by the National Institute for Health and Clinical Excellence (NICE) for use much earlier in the treatment pathway.

Adult patients with advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to first-line platinum-based chemotherapy can now be offered olaparib as maintenance therapy if they are BRCA mutation positive, NICE has said in its draft final guidance published.

The medicine, a tablet taken twice a day, will be paid for through the Cancer Drugs Fund only if the conditions of the managed access agreement between the company and NHS England and NHS Improvement for olaparib are followed. Around 700 patients a year are expected to benefit from this decision.

The use of the Cancer Drugs Fund is needed while further data is collected from an ongoing clinical trial (SOLO-1) which so far estimates that olaparib delays disease progression by around three years compared with placebo. However, it is not known whether people taking olaparib live longer because those on the trial have not been followed-up for long enough.

People living with BRCA mutation-positive advanced ovarian, fallopian tube or peritoneal cancer have a high unmet clinical need as there are currently no maintenance treatments after a positive response to first-line platinum-based chemotherapy. The committee noted the disease has a poor prognosis and patients live with the fear of relapse.

Olaparib is a PARP inhibitor and works by preventing the PARP protein in cancer cells from repairing damaged DNA, causing the cancer cells to die.

Meindert Boysen, Director of the NICE Centre for Health Technology Evaluation, said: “The availability of olaparib tablets as maintenance therapy is an important development in the management of BRCA mutation-positive advanced ovarian cancer. Olaparib is already used for ovarian cancer but is expected to have the greatest benefit when used early, and is considered to have the potential to cure the disease in some people if given before the first recurrence.

“We are pleased that the company has agreed a commercial arrangement for olaparib that will allow it to be made available immediately to people who currently have an unmet need for maintenance treatment.”

John Stewart, NHS Director of Specialised Commissioning, said:“Olaparib has the potential to make a huge impact on the treatment of advanced ovarian cancer, giving patients a better chance of survival, and NHS England has worked closely with AstraZeneca and NICE to reach a deal that has clear benefits for those patients who would benefit, as well as industry and taxpayers.

“Providing the latest cutting edge treatments for patients through innovative drug deals is just one way the NHS Long Term Plan will transform cancer care across the country, building on the thousands more lives already being saved thanks to improving treatment.”

Dr Susana Banerjee, Consultant Medical Oncologist at The Royal Marsden and Team Leader in Gynaecological Cancers at the ICR, was co-author on the SOLO-1 trial. She said: “Maintenance treatment with olaparib heralds a new era for women with ovarian cancer; this is the first time we have seen such dramatic improvements in progression-free survival. This means that more women will have a longer time before relapse, time of chemotherapy and the possibility of increased survival.

“The Landmark trial SOLO-1 led to a paradigm shift in the treatment of women with advanced ovarian cancer. This is the first trial of maintenance treatment with this type of drug for newly diagnosed patients. The trial results to date have shown that olaparib maintenance therapy extends progression-free survival by around three years in women with BRCA mutation linked advanced ovarian cancer. Some of my patients who have been treated in this trial at The Royal Marsden remain cancer-free several years later.”

Olaparib will be available to NHS patients through the Cancer Drugs Fund in England immediately. Subject to appeal, NICE’s final guidance will be published next month (August).