Eisai Receives European Commission Approval of Indication Expans

Eisai Receives European Commission Approval of Indication Expansion for
Anticancer Agent Halaven for Advanced Breast Cancer After Only One Prior
Chemotherapy 
Tokyo, July 3, 2014 - (JCN Newswire) -  Eisai Co., Ltd. (Headquarters: Tokyo,
CEO: Haruo Naito, "Eisai") announced today that it has received
approval from the European Commission of the indication expansion of Halaven
(generic name: eribulin mesylate, "eribulin") to contribute to
earlier treatment of patients with locally advanced or metastatic breast cancer
who have progressed after at least one chemotherapeutic regimen for advanced
disease. Prior therapy should have included an anthracycline and a taxane in
either the adjuvant or metastatic setting, unless patients were not suitable
for these treatments. 
Halaven is currently indicated in Europe 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. The approval received from the European Commission is for the
expansion of the current indication, which was limited to patients who had
previously received at least two chemotherapeutic regimens, to include patients
with metastatic breast cancer who have had less prior treatment. Through this
indication expansion, Halaven will now be able to contribute at an earlier
stage to patients with metastatic breast cancer in countries of the European
Union.
The approval is based on evidence from two pivotal Phase III studies,
including the Phase III clinical study (Study 305: EMBRACE) of Halaven versus
Treatment of Physician's Choice (TPC) in patients with locally advanced or
metastatic breast cancer who had previously received at least two to five prior
chemotherapeutic regimens including treatments with an anthracycline and a
taxane, and a Phase III clinical study (Study 301) of Halaven versus
capecitabine in women with locally advanced or metastatic breast cancer who had
received prior treatment with an anthracycline and a taxane. These studies
involved more than 1,800 patients, making this one of the largest data sets in
metastatic breast cancer.
Over 300,000 women are diagnosed with breast cancer in Europe every year, of
whom about one third subsequently develop metastatic disease1,2. Although
advances are being made in the treatment of breast cancer each year with the
development of new diagnostic technologies and anticancer agents, the unmet
medical needs of patients with metastatic breast cancer continue to remain
high. Eisai remains committed to providing scientific evidence aimed at
maximizing the value of Halaven as it seeks to make further contributions to
address the diversified needs of, and increase the benefits provided to,
patients with cancer and their families as well as healthcare providers. 
1. About Halaven (eribulin mesylate) 
Halaven, a non-taxane, microtubule dynamics inhibitor with a novel mechanism
of action, 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 sequestering tubulin into
nonproductive aggregates. Halaven was first approved as a treatment for breast
cancer in the United States in November 2010, and is approved in more than 50
countries worldwide, including European Union member states, Japan, Singapore
and Switzerland. In Japan, the drug has been approved to treat inoperable or
recurrent breast cancer and was launched in the country in July 2011.
Furthermore, with the aim of maximizing value of the drug, Eisai is currently
moving ahead with developments investigating the potential of Halaven as a
therapy in the treatment of breast cancer with fewer prior treatments as well
as soft-tissue sarcoma and non-small cell lung cancer. 
2. About Study 305 (EMBRACE) 
In the Phase III clinical study (Study 305, EMBRACE) of Halaven versus
treatment of physician's choice (TPC) in 762 patients with locally
advanced or metastatic breast cancer previously treated with an anthracycline
and a taxane, Halaven indicated extended overall survival (OS) of 2.5 months
(OS of 13.1 months versus 10.6 months, respectively; Hazard Ratio (HR) 0.81;
p=0.041) when compared to selected, major existing therapies. An updated
analysis of OS (not protocol-specified) in the EMBRACE study was also performed
at the request of European and U.S. regulatory authorities. These results
demonstrated an increase of 2.7 months in OS for Halaven compared with TPC (OS
of 13.2 months versus 10.5 months, respectively; HR 0.81; p=0.014). The most
common adverse reactions (events with an incidence rate of at least 25%) among
patients treated with Halaven were asthenia (fatigue), neutropenia, alopecia
(hair loss), peripheral neuropathy (numbness and tingling in arms, legs and/or
other parts of the body), nausea and constipation. The most common serious side
effects reported in patients receiving Halaven were neutropenia. The most
common adverse reaction resulting in discontinuation of treatment with Halaven
was peripheral neuropathy (5%). 
3. About Study 301 
Study 301 was an open-label, randomized, two-parallel-arm, multicenter study
designed to evaluate Halaven versus capecitabine in 1,102 women with locally
advanced or metastatic breast cancer who had up to three prior chemotherapy
regimens in the (neo)adjuvant setting, and no more than two prior regimens for
locally advanced and/or metastatic disease. The regimens must have included an
anthracycline and a taxane. Although Halaven did not achieve a statistically
significant result when compared to capecitabine in terms of overall survival
(OS) and progression-free survival (PFS), the co-primary endpoints of the
study, Halaven did demonstrate a trend favouring improved OS (Halaven median
OS: 15.9 months, capecitabine median OS: 14.5 months; HR 0.879; 95% CI:
0.770-1.003; p=0.056). Additionally, a later PFS assessment carried out by an
independent evaluation body concluded that there was no significant difference
between the two drugs (Halaven median PFS: 4.1 months, capecitabine median PFS:
4.2 months, HR 1.079; 95% CI: 0.932-1.250; p=0.305). In regard to safety,
adverse events (AEs) were consistent with the known side-effect profiles of
both drugs. The most common AEs (events with an incidence rate of at least 20%)
for Halaven and capecitabine were, respectively, neutropenia (54.2% vs. 15.9%),
hand-foot syndrome (0.2% vs. 45.1%), alopecia (34.6% vs. 4.0%), leukopenia
(31.4% vs. 10.4%), diarrhea (14.3% vs. 28.8%), and nausea (22.2% vs. 24.4%). 
References 
(1) World Health Organization. Atlas of Health in Europe. 2003. World Health
Organization, Regional Office of Europe, Copenhagen, Denmark.
(2) Cancer Research UK. Breast cancer incidence statistics.
www.cancerresearchuk.org/cancer-info/cancerstats/types/breast/incidence/#world. 
About Eisai 
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care
(hhc) company that discovers, develops and markets products throughout the
world. Eisai focuses its efforts in three therapeutic areas: integrative
neuroscience, including neurology and psychiatric medicines; integrative
oncology, which encompasses oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of research
facilities, manufacturing sites and marketing subsidiaries, Eisai actively
participates in all aspects of the worldwide healthcare system. For more
information about Eisai Co., Ltd., please visit www.eisai.com. 
Contact: 
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120 
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