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New Breast Cancer Treatment Available in France

3 pages
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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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
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