New Breast Cancer Treatment Available in France

Description

New Breast Cancer Treatment Available in France PR Newswire HATFIELD, England, July 10, 2012 HATFIELD, England, July 10, 2012 /PRNewswire/ -- ®Reimbursement granted for Halaven (eribulin) for women with locally advanced or metastatic breast cancer ®Halaven (eribulin), a novel treatment for patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease, has today received reimbursement approval from the French health authorities. Prior therapy should have included two common types of chemotherapy, an anthracycline [1]and a taxane, unless patients were not suitable for these treatments. Eribulin is the first, single-agent chemotherapy to demonstrate a prolonged overall survival in patients with heavily pre-treated advanced breast cancer, compared [2]to other single agent chemotherapies. Breast cancer is the most common cancer amongst women in France, [3]accounting for 35.5% of all cancers and has the highest mortality rate of all cancers in France. Information on French cancer statistics from The Fédération Nationale des Centres de Lutte Contre le Cancer, estimate that there are approximately 13,400 new cases of metastatic breast cancer every year in [4]France. It is estimated that up to 7,400 patients will be able to benefit from eribulin per year in France, and the new drug is already being used in a number [5]of key cancer treatment institutions.

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• Publié par: eisai-europe-limited
• Nombre de lectures: 13
• Langue: English

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New Breast Cancer Treatment Available in

France

PR Newswire

HATFIELD, England, July 10, 2012

HATFIELD,

England

,

July 10, 2012

/PRNewswire/ --

Reimbursement granted for Halaven

®

(eribulin) for women with locally

advanced or metastatic breast cancer

Halaven

®

(eribulin), a novel treatment for patients with locally advanced or

metastatic breast cancer who have progressed after at least two

chemotherapeutic regimens for advanced disease, has today received

reimbursement approval from the French health authorities. Prior therapy

should have included two common types of chemotherapy, an anthracycline

and a taxane, unless patients were not suitable for these treatments.

[1]

Eribulin

is the first, single-agent chemotherapy to demonstrate a prolonged overall

survival in patients with heavily pre-treated advanced breast cancer, compared

to other single agent chemotherapies.

[2]

Breast cancer is the most common cancer amongst women in

France

,

accounting for 35.5% of all cancers

[3]

and has the highest mortality rate of all

cancers in

France

. Information on French cancer statistics from The Fédération

Nationale des Centres de Lutte Contre le Cancer, estimate that there are

approximately 13,400 new cases of metastatic breast cancer every year in

France

.

[4]

It is estimated that up to 7,400 patients will be able to benefit from

eribulin per year in

France

, and the new drug is already being used in a number

of key cancer treatment institutions.

[5]

Dr Joseph Gligorov from Tenon Hospital APHP,

Paris, France

commented; "From

my clinical experience of eribulin to date, this drug is a promising treatment

option for women with heavily pre-treated breast cancer. I have treated many

women with eribulin who have had a good experience, not only regarding the

efficacy but also the side effect profile that is expected and manageable."

"It is really encouraging to see that the French health authorities recognise the

innovative drug status and clinical value eribulin may offer to women with

locally advanced or metastatic breast cancer. The approval for reimbursement

in

France

underscores the potential importance of this treatment and it is a

positive step forward for women affected by this disease. Patients who are

eligible may now benefit from a novel treatment that may extend their lives, a

notion that had until now been deemed unrealistic," commented Evelyne

Lepetit, Oncology Business Unit Head for

France

, Eisai Europe.

In addition to the French authorities granting reimbursement for the use of

eribulin in heavily pretreated women with metastatic breast cancer, Eisai

announces it is expanding its footing in the Israeli market with the registration

grant of eribulin.

Notes to Editors

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. 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.

Eribulin received European Commission approval on

17 March 2011

based on

the results of the Phase III EMBRACE study. Eribulin is approved in the European

Union,

USA

,

Switzerland

,

Japan

, and

Singapore

. In

Europe

, eribulin is currently

commercially available in

Austria

,

Denmark

,

Estonia

,

France

,

Finland

,

Germany

,

Iceland

,

Ireland

,

Italy

,

Japan

,

Luxembourg

,

Netherlands

,

Norway

,

Poland

,

Sweden

,

Switzerland

, and the

United Kingdom

.

Global Phase III Clinical Study (EMBRACE)

[2]

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.

[2]

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 2.5 months compared to patients

receiving TPC (eribulin 13.1 months vs. TPC 10.6 months p=0.014).

[1,2]

An

updated analysis, demonstrated a statistically significant improvement of 2.7

months (13.2 vs 10.5 HR 0.81 (95% CI 0.067, 0.96) nominal p=0.014).

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.

[2]

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, African

and Russian (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

,

Belgium

,

Luxembourg

, the

Middle East

and

Russia

.

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

References

1. SPC Halaven (updated

March 2011

). Available at:

http://www.medicines.org.uk/EMC/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+injection/

.

Last accessed

October 2011

2. Cortes J et al. The Lancet. 2011; 377: 914-923

3. GLOBOCAN. 2008. Breast Cancer in

France

. Available at:

http://globocan.iarc.fr/factsheets/populations/factsheet.asp?uno=250#KEY

Last

accessed

November 2011

4. Launois R et al. PharmacoEconomics 1997: 11(5): 495-497

5. Eisai. Data on file