Positive NICE recommendation for Halaven for patients with locally advanced or metastatic breast cancer

Is the first breast cancer treatment to be recommended by NICE in nearly a decade.

Eribulin is indicated in the European Union (EU) for the treatment of adults with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments. NICE has recommended Eribulin for the treatment of adults with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimen for advanced disease. Prior therapy may have included an anthracycline or a taxane, and capecitabine.

"Eribulin was approved in March 2011 and after years of uncertainty for patients and poor management of the Cancer Drugs Fund, people with locally advanced or metastatic breast cancer in England will finally now have routine access to eribulin. Over a period of more than 5 years, Eisai has shown great flexibility in pricing to maintain patient access to eribulin both in the CDF and with NICE and would like the same opportunity to enable access to our newer cancer drug lenvatinib for radioiodine refractory differentiated thyroid cancer patients, however so far an unacceptable process has again taken precedence over patients," comments Gary Hendler, Chairman & CEO Eisai EMEA.

Approximately 44,500 women are diagnosed with breast cancer in England each year, of whom one third subsequently develop metastatic disease. Only 15% of women with metastatic breast cancer will survive beyond 5 years. Eribulin is one of the most prescribed treatments within the CDF and to date approximately 4,000 patients have been able to access eribulin in the UK since 2011.

"I am delighted that women in England with locally advanced or metastatic breast cancer will continue to be able to access eribulin, and that the future of this treatment within the NHS is secure. Eribulin significantly improves overall survival in women with this disease and it is therefore an important option against breast cancer," comments Dr Mark Harries, Consultant Medical Oncologist.

Eribulin was first approved and launched in the UK in 2011 and marketing authorisation was extended for earlier use in advanced breast cancer from the European Commission on 3 July 2014. Eribulin is currently approved in more than 60 countries around the world including all of the EU, Canada, US, Russia, Switzerland, South Korea, Japan and Singapore.