Eisai's Eribulin (Halaven(R)) Receives Swissmedic Approval for use in Locally Advanced and Metastatic Breast Cancer

HATFIELD, England, May 17, 2011 /PRNewswire/ -- Eribulin (Halaven(R)) is today approved for use in Switzerland by Swissmedic, the Swiss Agency for Therapeutic Products, as a monotherapy treatment of patients with locally advanced and metastatic breast carcinoma with progression after prior therapy with an anthracycline, a taxane and capecitabine.[1] Breast cancer is the second most commonly diagnosed cancer worldwide and there are about 1.3 million new cases of the disease annually.[2] More than 5,000 Swiss women have the disease and approximately 1,400 are likely to die annually.[3]

Eisai submitted a New Drug Application based on the results from a Phase II study (Study 211) of eribulin in order to deliver the medicine to patients as quickly as possible. The approval was based upon the Phase II and Phase III data.[4]

Dr Matti Aapro, Dean of the Multidisciplinary Oncology Institute, Genolier, Switzerland commented, "This is a significant medical advance in a setting where there is currently no recognised standard of care. Until now we have not had robust clinical trial data to guide our treatment of these patients so I welcome today's news of the Swissmedic approval for use of eribulin which will allow patients in Switzerland to gain access to this important new treatment. The EMBRACE study demonstrates that eribulin is an effective and relatively well-tolerated treatment, as well as the first single agent chemotherapy to provide statistically significant overall survival improvements for patients with metastatic breast cancer previously treated with an anthracycline and a taxane.*"

The Swissmedic approval means that patients in Switzerland will soon be able to benefit from this innovative treatment. Eribulin is approved for treatment for women with locally advanced or metastatic breast cancer who have progressed after previous treatment with an anthracycline, a taxane and capecitabine.

Eribulin is the first single-agent chemotherapy to demonstrate a significant overall survival benefit in patients with advanced breast cancer in the population studied within EMBRACE. The Swissmedic approval means that patients in Switzerland will soon be able to benefit from this innovative treatment.

Eribulin was approved in the USA in November 2010, in Singapore in February 2011, in Europe in March 2011 and Japan in April 2011, and has already been launched in USA, UK, Nordics and Japan.

Eisai's commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, biologic and supportive care agents for cancer across multiple indications. Through these efforts, Eisai will make further contributions to addressing the diversified needs of and increasing the benefits provided to patients and their families as well as healthcare professionals as it seeks to fulfill its human health care (hhc) mission.

NOTES TO EDITORS

About Eribulin

Eribulin is a non-taxane, microtubule dynamics inhibitor, fully synthetic analogue, belonging to a class of antineoplastic agents, the halichondrins, which are natural products isolated from the marine sponge Halichondria okadai[5],[6]. Eribulin targets microtubules, the major cytoskeletal component of cells which play a pivotal role in cell replication. Alteration of microtubule dynamics can cause a cell to stop dividing and self destruct.

About the 211 Study

Study 211 is a Phase II, open-label, single-arm study evaluating the efficacy and safety of eribulin in patients with locally advanced or metastatic breast cancer who had received an anthracycline, a taxane and capecitabine as prior therapy, and who were refractory to their last chemotherapy regimen, as documented by progression on or within six months of that therapy. Of 299 patients enrolled in the study, 291 were treated with eribulin. Two-hundred sixty-nine patients met the key inclusion criteria. Independent assessment of objective response rate (ORR) was 9.3%. Nearly half (46.5%) the patients had stable disease after treatment with eribulin. The median duration of response was 4.1 months. Median progression-free survival was 2.6 months, and the median overall survival rate was 10.4 months. The six-month PFS and OS rates were 15.6% and 72.3%, respectively.[7]

The safety analysis included all 291 patients who received treatment with eribulin. The most frequently reported Grade 3 or Grade 4 adverse events were neutropenia 54%, febrile neutropenia 5.5%, leucopenia 14%, and weakness/fatigue (10%; no Grade 4 events). Grade 3 peripheral neuropathy was reported in 6.9% of patients. No Grade 4 peripheral neuropathy events were reported.[7]

About EMBRACE

EMBRACE was an open-label, randomised, multi-centre study of 762 women with MBC who were previously treated with at least two and a maximum of five prior chemotherapies (greater than or equal to 2 for advanced disease), including an anthracycline and a taxane. Patients must have been refractory to the most recent chemotherapy, documented by progression on or within six months of therapy. The study was designed to compare OS in patients treated with eribulin versus a TPC arm, reflecting a real-world clinical setting where a variety of agents are used to treat patients. The primary endpoint was OS. Secondary endpoints were objective response rate, progression-free survival, safety and duration of response.[4]

About Metastatic Breast Cancer

Worldwide, more than one million women a year are diagnosed with breast cancer, including 421,000 women in Europe.[8,9] Approximately 30 percent of women initially diagnosed with earlier stages of breast cancer eventually develop recurrent or metastatic disease,[10] and while around 9 out of 10 of women diagnosed with early stage breast cancer survive beyond five years, this drops to around 1 in 10 among women first diagnosed with MBC.[11] Most MBC patients have a limited survival time of approximately 18-24 months.[12]

Eisai in Oncology

Eisai is dedicated to discovering, developing and producing 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 for better understanding of the needs of patients and their families to increase the benefits health care provides. Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, biologic and supportive care agents for cancer across multiple indications.

Eisai Europe Limited

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

- Integrative Neuroscience, including: Alzheimer's disease, multiple sclerosis, neuropathic pain, epilepsy, depression

- Integrative Oncology, including: anticancer therapies; vaccines, tumor regression, tumor suppression, antibodies and supportive cancer therapies; pain relief, nausea

- Vascular/Immunological reaction, including: acute coronary syndrome, atherothrombotic disease, severe sepsis, rheumatoid arthritis, psoriasis, Crohn's disease

- In Europe, Eisai undertakes sales and marketing operations in over 20 markets.

Eisai

Eisai is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs approximately 11,000 employees worldwide.

For further information, please visit http://www.eisai.co.jp.

* Eribulin-mesylate is indicated for the treatment of patients with locally advanced or metastatic breast cancer that has progressed after prior anthracycline, taxane, and capecitabine therapy. ---------------------------------

[1] Swiss medic approval letter

[2] Sources: GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10 [Internet]

[3] http://globocan.iarc.fr/factsheets/populations/factsheet.asp?uno=756

[4] Cortes J, O'Shaughnessy J, Loesch D, et al. A Phase III open-label randomized study (EMBRACE) or eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer. The Lancet. 2011; 377: 914 -923

[5] Kuznetsov G, Towle MJ, Cheng H, et al: Induction of morphological and biochemical apoptosis following prolonged mitotic blockage by halichondrin B macrocyclic ketone analog E7389. Cancer Res 2004; 64: 5760-5766

[6] Towle MJ, et al. In Vitro and In Vivo Anticancer Activities of Synthetic Macrocyclic Ketone Analogues of Halichondrin B. Cancer Res 2001; 61: 1013-1021

[7] Cortes et al. Phase II Study of the Halichondrin B Analog Eribulin Mesylate in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane, and Capecitabine. Jour Clin Oncol, September 1, 2010 vol. 28 no. 25 3922-3928.

[8] Coughlin, S. Breast cancer as a global health concern. Cancer Epidemiology, October 2009; 33: 315-18.

[9] Ferlay J, Parkin DM, Steliarova-Foucher E. Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer.2010: 46(4):765-781

[10] O'Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. Oncologist. 2005;10 Suppl 3:20-29

[11] Cancer Research UK, Breast Cancer Statistics - Key Facts [updated April 2010]. Available from: http://info.cancerresearchuk.org/cancerstats/types/breast/index.htm?script=true (accessed (04/08/10)

[12] Fernandez Y, Cueva J, Palomo AG, et al. Novel therapeutic approaches to the treatment of metastatic breast cancer. Cancer Treat Rev.2010:36(1):33-42

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