Life-extending Metastatic Breast Cancer Treatment Halaven® (Eribulin) Launches in Australia
Halaven® (eribulin) has received reimbursement in Australia for the treatment of patients with locally advanced or metastatic breast cancer.[1] The agent is one of the few breast cancer treatments to be approved by the Australian Pharmaceutical Benefits Scheme (PBS) in recent years. Eribulin is the first, single-agent chemotherapy to demonstrate prolonged overall survival in women with heavily pre-treated advanced breast cancer compared to other single agent chemotherapies after anthracycline and taxane treatment.
Eribulin is indicated in Europe for the 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.[2]
"New treatment options for Australian women with locally advanced or metastatic breast cancer are welcomed by doctors, patients and their families as there remains a high unmet need for improved therapies. People who have been progressed on previous therapies urgently need new treatments that have demonstrated an overall survival benefit, so the availability of Halaven is very good news," commented Associate Professor Paul Mainwaring, medical oncologist at The Mater Hospital, Brisbane.
Breast cancer is the most common cancer diagnosed in Australian women with one in eight women likely to be diagnosed by the age of 85.[3] Breast cancer is the second leading cause of cancer-related death in Australia and accounts for over 15% of all cancer deaths in women.[3]In 2014 it is estimated that more than 15,000 Australian women will be diagnosed with breast cancer.[4]
"Breast cancer is a major health issue across the world and one that can have a significant impact on women and their families. We are pleased to launch Halaven in Australia as a new treatment option for women in this country and also to expand on the regions in which this key therapy is available," commented Gary Hendler, President & CEO, Eisai EMEA.
The approval and reimbursement of eribulin in Australia is based on the results of the pivotal Phase III EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice (TPC) Versus Eribulin E7389) study.[5]
In the EMBRACE study population (n=762), eribulin is shown to prolong overall survival in heavily pre-treated patients with metastatic breast cancer by 2.5 months compared to patients receiving Treatment of Physicians Choice (TPC), which represents a mix of real-life treatment choices (eribulin 13.1 months vs. TPC 10.6 months, HR 0.81 (95% CI 0.66, 0.99), p=0.041). Updated data confirms that patients treated with eribulin survived a median of 2.7 months longer than patients who received TPC (overall survival of 13.2 months versus 10.5 months, respectively, HR 0.81 (95% CI 0.067, 0.96), nominal p=0.014).[5]
The most commonly reported adverse reactions among people treated with eribulin were asthenia (fatigue), neutropenia, alopecia (hair loss), peripheral neuropathy (numbness and tingling in arms and legs), nausea and constipation.[5]
Eisai is dedicated to the discovery, development and production of innovative oncology therapies that can make a difference and impact the lives of women 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.
Notes to Editors
Halaven® (eribulin)
Eribulin is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division.
Global Phase III Clinical Study 305 (EMBRACE)[5]
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 (OS) in women treated with eribulin versus a 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 participants with MBC 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 participants in the TPC arm received chemotherapy.
In the total Phase III EMBRACE study population, eribulin was shown to prolong median OS in heavily pre-treated women with MBC compared to women receiving TPC by 2.7 months (13.2 vs 10.5 HR 0.81 (95% CI 0.67, 0.96) nominal p=0.014). A pre-planned analysis of participants from Region 1 of the study (North America/Western Europe/Australia) showed a significant median OS benefit of eribulin over TPC of 3.0 months (nominal p=0.031).
The most commonly reported adverse reactions among people 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 women involved in the EMBRACE trial. Neutropenia only led to eribulin discontinuation for 0.6%. 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.
Metastatic Breast Cancer
Over 300,000 women are diagnosed with breast cancer in Europe every year, of whom about one third subsequently develop metastatic disease.[6],[7]Metastatic disease is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body.
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 Co., Ltd.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Oncology and Neurology.
As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.
For more information about Eisai Co., Ltd., please visit http://www.eisai.com.
References
1. Australia Government, Department of Health. Pharmaceutical Benefits Scheme. Available at http://www.pbs.gov.au/pbs/home Accessed: September 2014
2. SPC Halaven (updated June 2014). Available at: http://www.medicines.org.uk/emc/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+injection/ Accessed: September 2014
3. Breast cancer care WA. Statistics. Available at: http://www.breastcancer.org.au/about-breast-cancer/statistics.aspx?gclid=CKbJ8v3Fo7wCFYUIwwod3BUA8A . Last accessed September 2014.
4. Australian Institute of Health and Welfare 2012. Cancer incidence projections: Australia, 2011 to 2020. Cancer Series no. 66. Cat. No. CAN 62. Canberra: AIHW. Available at: http://canceraustralia.gov.au/affected-cancer/cancer-types/breast-cancer/breast-cancer-statistics Accessed: September 2014
5. 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
6. World Health Organisation. Atlas of Health in Europe. 2003. World Health Organization, Regional Office of Europe, Copenhagen, Denmark.
7. Cancer Research UK. Breast cancer incidence statistics. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/breast/incidence/#world . Accessed: September 2014
Date of preparation: September 2014
Job code: Halaven-UK0352
 Launches in Australia)
