German Federal Regulator Confirms Additional Benefit of eribulin for Metastatic or Locally Advanced Breast Cancer

Frankfurt And Hatfield, England (ots/PRNewswire) -

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The German Federal Joint Committee (G-BA), the supreme
decision-making body of the self-governing medical system in Germany,
announced that it considers the use of Halaven(R) (eribulin) to have
additional benefit versus comparative treatments, defined by the G-BA
for women who have already had extensive prior treatment of
metastatic or locally advanced breast cancer.[1]

Today's assessment by the G-BA is based on the results of the
EMBRACE study, previously published in The Lancet. This pivotal phase
III study, demonstrates that eribulin is the first, single-agent
chemotherapy to show a statistically significant overall survival
benefit in women with heavily pre-treated advanced breast cancer
(compared to treatment of physician choice). Eribulin has an expected
and manageable safety profile which is in line with other
single-agent chemotherapy treatments for advanced breast cancer in
this setting.[2]

"Eisai recognises the decision of the G-BA which demonstrates
support for innovative medicines in the area of oncology, where there
are few treatment choices. The development of breakthrough
chemotherapies such as Halaven is vital to prolong the time women
with advanced breast cancer can spend with their loved ones."
Commented Frank Zeymer, Eisai's Oncology Business Unit Director,
Region Central, based in Germany.

Eribulin is approved in Europe for the treatment of patients with
locally advanced or metastatic breast cancer whose disease has
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]

Notes to Editors

Halaven(R) (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.[2] 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.

Halaven is approved in the European Union, USA, Switzerland,
Japan, and Singapore. In Europe, Halaven has received pricing
authorisation and been launched in Austria, Denmark, Finland,
Germany, Iceland, Italy, Norway, Sweden, Switzerland, Slovenia, and
the UK.

Global Phase III Clinical Study (EMBRACE)

EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment
of Physician's Choice (TPC) Versus Eribulin E7389) 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 (96%) of patients in the TPC arm received chemotherapy.[3]

In the total Phase III EMBRACE study population, eribulin was
shown to prolong overall survival in heavily pre-treated patients
with metastatic breast cancer compared to patients receiving TPC by
2.7 months (13.2 vs 10.5 HR 0.81 (95% CI 0.067, 0.96) nominal
p=0.014).[2] A pre-planned analysis of patients from Region 1 of the
study (North America/Western Europe/Australia) showed a significant
overall survival benefit of eribulin over TPC of 3.0 months (nominal
p=0.031).[2]

The most commonly reported adverse reactions among patients
treated with eribulin in the EMBRACE study were fatigue (asthenia), a
decrease in infection-fighting white blood cells (neutropenia), hair
loss (alopecia), numbness and tingling in arms and legs (peripheral
neuropathy), nausea and constipation. Peripheral neuropathy was the
most common adverse event leading to discontinuation from eribulin,
occurring in less than 5% of the patients involved in the EMBRACE
trial. Neutropenia only led to eribulin discontinuation for 0.6%
patients. Death due to serious side effects, discontinuation and dose
interruptions to treatment were lower in the eribulin arm of the
trial compared with the TPC arm.[3]

Metastatic Breast Cancer

Metastatic breast cancer is an advanced stage of the disease that
occurs when cancer spreads beyond the breast to other parts of the
body. In Europe, approximately 6% of breast cancers are metastatic at
diagnosis with a five-year survival rate of 21%.[4]

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, and biologic and supportive care agents for cancer across
multiple indications.

About Eisai

Eisai is one of the world's leading R&D-based pharmaceutical
companies and 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
recently expanded their UK Hatfield facility which now supports the
company's growing European, Middle Eastern and African (EMEA)
business.

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

- Neuroscience, including: Alzheimer's disease, multiple sclerosis,
neuropathic pain, epilepsy, depression
- Oncology including: anticancer therapies; tumour regression, tumour
suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea
- Vascular/Immunological reaction including: acute coronary syndrome,
atherothrombotic disease, rheumatoid arthritis, psoriasis, Crohn's disease

With operations in the U.S., Asia, Europe and its domestic home
market of Japan, Eisai employs more than 11,000 people worldwide. 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, Slovakia, the Netherlands, and
Belgium.

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

1.
http://www.g-ba.de/informationen/nutzenbewertung/12/#tab/beschluesse

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/S
PC/Halaven+0.44+mg+ml+solution+for+injecti on/ [http://www.medicines
.org.uk/EMC/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+inject
ion ]

4. Cardoso, M. and Castiglione F. Locally recurrent or metastatic
breast cancer: ESMO Clinical Recommendations for diagnosis, treatment
and follow-up. On behalf of the ESMO Guidelines Working Group. Ann
Oncol (2009) 20 (suppl 4): iv15-iv18

Eribulin-UK2163

April 2011

ots Originaltext: Eisai Europe Limited
Im Internet recherchierbar: http://www.presseportal.de

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