Healthcare Industry News:  capecitabine 

Biopharmaceuticals Oncology Regulatory

 News Release - November 3, 2016

Eisai Welcomes Positive NICE recommendation for Halaven(R) (eribulin) for Patients with Locally Advanced or Metastatic Breast Cancer

HATFIELD, England, November 3, 2016 -- (Healthcare Sales & Marketing Network) -- The National Institute of Health and Care Excellence (NICE) has recommended Halaven® (eribulin) for the treatment of locally advanced or metastatic breast cancer in a Final Appraisal Determination published today. Eribulin is the first breast cancer treatment to be recommended by NICE in nearly a decade.[1]

Eribulin is indicated in the European Union 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.[2] NICE has today 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.[3]

"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 five 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,[4] of whom one third subsequently develop metastatic disease.[5] Only 15% of women with metastatic breast cancer will survive beyond five years.[6] 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.[7]

"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 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.

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.

Metastatic Breast Cancer

Over 300,000 women are diagnosed with breast cancer in Europe every year,[8] of whom about one third subsequently develop metastatic disease.[5] Metastatic disease is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body.

About Eisai EMEA in Oncology

Eisai is committed to the development and delivery of highly beneficial new treatments for people with cancer. The development of therapeutic options in oncology is a major strategic area for Eisai in Europe, the Middle East, Africa, Russia and Oceania (EMEA). In the European Union, Eisai currently has three marketed treatments across four indications:
  • Lenvima® (lenvatinib) is indicated for the treatment of adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma (DTC) refractory to radioactive iodine (RAI).
  • Kisplyx® (lenvatinib) is indicated in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
  • Halaven® (eribulin) is indicated for the treatment of adults with locally advanced or metastatic breast cancer who have received 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. Halaven® (eribulin) is also indicated for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.
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.

References

1. NICE: https://www.nice.org.uk/guidance/conditions-and-diseases/cancer/breast-cancer Accessed: November 2016

2. Halaven (eribulin) SPC (updated August 2016). Available at: https://www.medicines.org.uk/emc/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+injection/ Accessed: November 2016

3. NICE: https://www.nice.org.uk/news Accessed: November 2016

4. 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. Accessed: November 2016

5. O'Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. The Oncologist. 2005;10(Suppl 3):20-29.

6. Cancer Research UK, Breast Cancer - Outlook by Grade - Available at: http://www.cancerresearchuk.org/about-cancer/type/breast-cancer/treatment/statistics-and-outlook-for-breast-cancer#overall Accessed November 2016

7. Eisai Data on File (ERI-219)

8. World Health Organization. Atlas of Health in Europe. 2003. World Health Organization, Regional Office of Europe, Copenhagen, Denmark.


Source: Eisai

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