Eisai to Present New Research on Halaven (Eribulin) at 35th Annual San Antonio Breast Cancer Symposium

News provided by

Eisai Europe Limited

28 Nov, 2012, 16:00 GMT

HATFIELD, England, November 28, 2012 /PRNewswire/ --

For European Medical Media Only

Eisai will be presenting six abstracts highlighting new study results for Halaven (eribulin) at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium. The meeting will be held December 4-8, 2012 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.  

These studies highlight Eisai's current and ongoing clinical research efforts with eribulin, reinforcing the company's commitment to continued research to patients and their families affected by metastatic breast cancer. Additionally, Phase III study results of the head-to-head study of eribulin vs capecitabine will be highlighted as part of a SABCS- sponsored conference to be held on 7 December, 2012.

"As part of our human health care mission we strive to better understand the needs of patients and their families to help address unmet medical needs and increase the benefits that healthcare provides," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai. "Our continued work to further understand the clinical profile of eribulin underscores our commitment to this important mission."

The following Eisai abstracts have been accepted for presentation at this year's San Antonio Breast Cancer Symposium:

    Product         Abstract Name
                    A Phase III, open-label, randomized, multicenter study of
    Eribulin        eribulin mesylate versus capecitabine in patients with
    Session:        locally advanced or metastatic breast cancer previously
    S6-6            treated with anthracyclines and taxanes
                    Oral Presentation
    Eribulin        Results of a Phase II, multicenter, single-arm study of
    Abstract No:    eribulin mesylate as first-line therapy for locally
    P1-12-02        recurrent or metastatic HER2-negative breast cancer
                    Poster Session
    Eribulin        Eribulin mesylate + trastuzumab as first-line therapy for
    Abstract No:    locally recurrent or metastatic HER2-positive breast
    P5-20-04        cancer: results from a Phase II, multicenter, single-arm
                    study
                    Poster Session
    Eribulin        Adjuvant treatment of early-stage breast cancer with
    Abstract No:    eribulin mesylate following dose-dense doxorubicin and
    P1-13-11        cyclophosphamide: preliminary results from a Phase II,
                    single-arm feasibility study
                    Poster Session
    Eribulin        Post-hoc safety and tolerability assessment in patients
    Abstract No.    receiving palliative radiation during treatment with
    P6-11-14        eribulin mesylate for metastatic breast cancer
                    Poster Session
    N/A             Family Members' Burden in Patients with Metastatic and
    Abstract No:    Early Stage Breast Cancer
    P6-09-06        Poster Session


The information discussed in this release is about investigational uses for eribulin. In Europe, eribulin is indicated 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.[1]It is not intended to convey conclusions of efficacy and safety.

- ENDS -

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.

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

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%.[2]

Eisai in Oncology

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 recently expanded their UK Hatfield commercial, research and manufacturing facility which now supports the company's growing EMEA business.

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

  • Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss
  • Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc.
  • Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel 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. Halaven (eribulin) Summary of Product Characteristics available from: http://www.medicines.org.uk/emc/medicine/24382 (Last accessed November 2012)  

2. 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

Date of preparation: November 2012

Job code: Halaven-UK0069