Halaven® (Eribulin) Remains Available for Patients with Advanced Metastatic Breast Cancer Who Have Progressed After at Least Two Chemotherapeutic Regimens Despite Recent NICE Draft Guidance in an Earlier Setting

HATFIELD, England, November 30, 2017 /PRNewswire/ --

The availability of Halaven^® (eribulin) for the treatment of adults with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens^[1] remains unaffected even though recent draft guidance from the National Institute of Health and Care Excellence (NICE) has not recommended it for use in an earlier setting.

Last year eribulin became the first breast cancer treatment to be recommended by NICE in nearly a decade for the treatment of adults with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens which may include an anthracycline or a taxane, and capecitabine.^[1] This year NICE is assessing eribulin for the treatment of patients with locally advanced or metastatic breast cancer after one chemotherapy regimen.

"Eisai is extremely disappointed with this decision particularly as eribulin received a positive recommendation from NICE for use after two chemotherapy regimens just last year. We stand firmly by the data submitted and will of course engage in further dialogue with NICE so that patients suffering from advanced breast cancer can have earlier access to eribulin," said Gary Hendler, Chief Commercial Officer Eisai Oncology Business Group, Chairman and CEO Eisai EMEA.

Approximately 55,200 women are diagnosed with breast cancer in England each year,^[2] of whom one third subsequently develop metastatic disease.^[3] Only 15% of women with metastatic breast cancer will survive beyond five years.^[4]

Eribulin was first approved and launched in the UK in 2011 and is currently approved in 64 countries around the world including all of the European Union, Canada, United States, Russia, Switzerland, South Korea, Japan and Singapore.

Eisai is dedicated to the discovery, development and production of innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives to better understand the needs of patients and their families to increase the benefits health care provides.

Notes to Editors   

Halaven^® (eribulin)  
Eribulin is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division.

About Eisai Co., Ltd. 
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit: http://www.eisai.co.uk/

References  

1. NICE: https://www.nice.org.uk/guidance/conditions-and-diseases/cancer/breast-cancer Accessed: November 2017
2. Cancer Research UK. Breast cancer incidence by sex and UK region. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast-cancer/incidence-invasive#heading-Zero [ http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast-cancer/incidence-invasive ]. Accessed: November 2017
3. O'Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. The Oncologist. 2005;10(Suppl 3):20-29.
4. Cancer Research UK, Breast Cancer - Outlook by Grade - Available at: http://www.cancerresearchuk.org/about-cancer/breast-cancer/survival Accessed November 2017