Scottish Medicines Consortium Rules Against Breast Cancer Treatment Halaven®(black triangle drug) (eribulin)

HATFIELD, England, October 10, 2011 /PRNewswire/ --

- Scottish women with metastatic breast cancer denied access to life-prolonging treatment   

The Scottish Medicines Consortium (SMC) announced today that it does not recommend funding for Halaven^®▼ (eribulin), a new treatment for locally advanced or metastatic breast cancer.^[1] This decision denies seriously ill patients with very limited treatment options access to a drug that has demonstrated a significant improvement in overall survival.^[2]

Eribulin is a novel monotherapy treatment indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.^[3]  Launched in the UK in April 2011, it is the first single agent chemotherapy to demonstrate prolonged overall survival in women with metastatic breast cancer who have had prior anthracycline and taxane treatment.^[4]  The SMC guidance is based on the EMBRACE Phase III clinical trials which showed a median overall survival benefit of 13.2 months for patients receiving eribulin compared to 10.5 months for patients receiving 'treatment of physician's choice' (TPC).^[2]

The side-effect profile of eribulin was expected and manageable. The most commonly reported adverse reactions among patients were asthenia (fatigue), neutropenia, alopecia (hair loss), peripheral neuropathy (numbness and tingling in arms and legs), nausea and constipation.^[2]

"Scottish women with advanced breast cancer are currently prejudiced in Scotland as their chances of accessing a life extending cancer drug are now much lower than their neighbours in England", points out Andrew Wilson, Chief Executive of the UK Rarer Cancers Foundation. "Our recent report 'Nations Divided' uncovered a profound difference in the availability of new cancer medicines between Scotland and England. Following the implementation of the Cancer Drug Fund (CDF) in England, patients in Scotland are now three times less likely than patients in England to receive the drugs that their clinician wishes to prescribe."

"We are hugely disappointed with this SMC decision as there is such a high unmet need in these women and our drug eribulin has shown that it improves overall survival by an additional three months compared to existing treatments", comments Nick Burgin, European Director of Market Access, Eisai. "We have tried to make eribulin affordable and offered a substantial discount on the price.  In fact, the price of our drug in Scotland is at the lowest anywhere in the world. Eisai is committed to improving the options available for patients with metastatic breast cancer and we plan to re-submit to the SMC later this year to try and reverse this unfair decision."

David Cameron, Professor of Oncology University of Edinburgh and Director of Cancer Services, NHS Lothian adds: "The EMBRACE Phase III study showed clearly that eribulin prolonged overall survival. Importantly, there were no unexpected side-effects in comparison with other treatment options in these heavily pre-treated patients with locally advanced or metastatic breast cancer, reflecting a predictable and manageable side effect profile. The main barrier to NHS use in Scotland is not related to the efficacy or safety of the drug, but to its cost-effectiveness as measured by the cost of treatment per quality adjusted life year or QALY. The price of eribulin is only one of the factors in this equation."

Eribulin is approved in the European Union, USA, Switzerland, Japan, and Singapore. It is currently commercially available in Austria, Denmark, Finland, Germany, Netherlands, Norway, Portugal, Spain, Sweden, Singapore, Switzerland, United Kingdom, the USA and Japan.    

Notes to Editors

Halaven is the EU trade name for eribulin.

Eribulin was launched on 20 April 2011 and is commercially available in the UK. It may be available in Scotland through private insurance companies.

Global Phase III Clinical Study (EMBRACE)
EMBRACE was an open-label, randomised, global, multi-centre, parallel two-arm study designed to compare overall survival in patients treated with eribulin versus a Treatment of Physician's Choice (TPC arm). TPC was defined as any single-agent chemotherapy, hormonal treatment or biologic therapy approved for the treatment of cancer; or palliative treatment or radiotherapy administered according to local practice. The study included 762 patients with metastatic breast cancer who previously had been treated with at least two and a maximum of five prior chemotherapies, including an anthracycline and a taxane. The vast majority (97%) of patients in the TPC arm received chemotherapy.^[2]

In the pre-planned analysis of patients from geographical Region 1 (North America/Western Europe/Australia) eribulin showed a significant overall survival benefit over TPC of 3.0 months, nominal p=0.031 (updated analysis). Eisai believes that data from Region 1 best represent how patients in the UK are managed.

The most common adverse reactions (incidence greater than or equal to 19%) among patients treated with Eribulin were asthenia (fatigue), neutropenia, alopecia (hair loss), peripheral neuropathy (numbness and tingling in arms and legs), nausea and constipation. The most common serious side effect reported in patients receiving eribulin was neutropenia, with or without fever (occurring in 45% and 5% of patients respectively).The most common adverse reaction resulting in discontinuation of treatment with eribulin was peripheral neuropathy (5%).^[2]

Metastatic Breast Cancer

Breast cancer is now the most common cancer in the UK and the lifetime risk of being diagnosed with breast cancer is 1 in 8 for women in the UK.^[5] Just over 4,000 women are diagnosed with breast cancer in Scotland each year.^[6]  

Around 1000 people die each year in Scotland from breast cancer.^[6] Metastatic breast cancer is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body. Approximately five percent of women with breast cancer will have metastatic disease at the time of diagnosis^[7] and others with local and regional disease may eventually develop metastatic disease.^[8] For women with early or localised breast cancer, metastatic disease will develop in 40 percent within 10 years.^[9] Only an estimated 13 percent of women presenting with metastatic breast cancer will survive beyond five years.^[7]

Halaven^® (eribulin)

Eribulin is a non-taxane, microtubule dynamics inhibitor indicated for the treatment of patients with breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease and whose prior therapy should have included an anthracycline and a taxane.^[3] Eribulin belongs to a class of antineoplastic agents, the halichondrins, which are natural products, isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequesters tubulin into non-productive aggregates.

About Eisai

Eisai is one of the world's leading R&D-based pharmaceutical companies that has defined its corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc).

Eisai concentrates its R&D activities in three key areas:

• Neuroscience: Alzheimer's disease, multiple sclerosis, neuropathic pain, epilepsy, depression, etc
• Oncology: Anticancer therapies; tumour regression, tumour suppression, antibodies, etc and Supportive cancer therapies; pain relief, nausea, etc
• Vascular/Immunological Reaction: Acute coronary syndrome, atherothrombotic disease, sepsis, rheumatoid arthritis, psoriasis, Crohn's disease, etc

With operations in the U.S., Asia, Europe and its domestic home market of Japan, we employ more than 10,000 people worldwide, and reported consolidated sales of over £3.53 billion in FY2007, an increase of 8.9% year on year. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Hungary, Slovakia and the Netherlands.

For further information please visit our web site http://www.eisai.com

References

1. Scottish Medicines Consortium advice on eribulin (SMC No. (726/11)). Available from http://www.scottishmedicines.org.uk/

2. Cortes J, O'Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. The Lancet. 2011; 377: 914 -923

3. Summary of Product Characteristics Halaven (updated March 2011). Available at: http://www.medicines.org.uk/EMC/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+injection/

4. Jassem J, Carroll C, Ward SE, Simpson E, Hind D. The clinical efficacy of cytotoxic agents in locally advanced or metastatic breast cancer patients pretreated with an anthracycline and a taxane: a systematic review. Eur J Cancer. 2009 Nov;45(16):2749-58.

5. Cancer Research UK. Cancer Statistics - Key Facts. Available from URL http://info.cancerresearchuk.org/cancerstats/types/breast/  (Accessed 1 April 2011)

6. Breast Cancer Care http://www.breastcancercare.org.uk/news/media-centre/facts-statistics

7. Cancer Research UK. Statistics and outlook for breast cancer. Available from URL http://www.cancerhelp.org.uk/type/breast-cancer/treatment/statistics-and-outlook-for-breast-cancer (Accessed 1 April 2011)

8. O'Shaughnessy. Extending Survival with Chemotherapy in Metastatic Breast Cancer. The Oncologist. 2005;10;20-29

9. NICE. Clinical guideline 81. 2009