Grayling

People in Sweden, Denmark and Finland with advanced liposarcoma now able to access Halaven® (Eribulin), first-ever treatment to prolong overall survival in rare and aggressive cancer

Dela

License variation provides an important new treatment option following global Phase III study showed median 7.2 month overall survival benefit

Hatfield, UK, 10 May 2016 - Halaven® (Eribulin) is now available in Sweden, Denmark and Finland for the treatment of adult patients with unresectable advanced or metastatic liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease. The news follows the decision by the European Commission to approve the licence variation to the terms of the Marketing Authorisation for Eribulin on 2 May. Eribulin is the first and only single agent therapy to show a significant survival advantage in this type of soft tissue sarcoma.[1]

Advanced liposarcoma, a soft tissue sarcoma subtype, is the second form of cancer for which Eribulin has a proven overall survival benefit. Eribulin is currently indicated for the treatment of women with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease.

It is estimated that approximately 1,200 people in the Nordics region live with a soft tissue sarcoma, based on an incidence rate of 4.7 in every 100,000.[2] Sarcomas represent approximately 1% of all cancers diagnosed in Europe.[3] Liposarcomas and leiomyosarcomas make up around 30% of all cases of soft tissue sarcomas, which develop from cells in essential tissues within the body such as fat, muscle, nerves, fibrous tissues and blood. [4],[5] Liposarcomas (adipocytic sarcomas) originate in fat cells and can occur anywhere in the body.5

Advanced liposarcoma is a rare and most often aggressive form of malignant tumour, and since it is difficult to treat, the patients often face a poor prognosis. Eribulin is the first and only single agent therapy to have a proven overall survival benefit in this soft tissue sarcoma subtype, which makes the news of its availability important. People with advanced liposarcoma and their physicians in the Nordic countries will be encouraged by this new treatment possibility,” comments Dr Mikael Eriksson at the Department of Oncology, Skane University Hospital in Lund.

The European Medicines Agency (EMA) approved Eribulin in May 2016. This decision was based on pivotal Phase III data which showed a median 7.2 month increase in overall survival compared to dacarbazine (15.6 months versus 8.4 months, HR = 0.511; 95% CI 0.346-0.753; P=0.0006) for people with unresectable advanced or metastatic liposarcomas1 (HR=0.768, 95% CI 0.618–0.954; P=0.017). There were no unexpected or new safety findings; the toxicity profile is consistent with the known safety profile of Eribulin.

Eribulin is a microtubule-dynamics inhibitor, structurally modified analogue of halichondrin B, originally isolated from the marine sponge Halichondria okadai. Its mode of action is distinct from other tubulin inhibitors and involves binding to specific sites on the growing positive ends of microtubules to inhibit their growth. Recent data for blood perfusion show that Eribulin may lead to remodelling of the tumour vasculature, resulting in an oxygenated environment.[6] Cancer cells thrive in a deoxygenated (hypoxic) environment and therefore improving tumour perfusion may lead to a decrease in tumour metastatic potency.[7]

“The availability of Eribulin in the Nordic region helps to fulfil our mission to provide treatments that improve the lives of people living with cancer across the globe. Eribulin has already demonstrated a significant overall survival benefit for women with advanced breast cancer, and now in advanced liposarcoma it has demonstrated a meaningful overall survival benefit where an unmet medical need persists,” comments Gary Hendler, Chief Commercial Officer Oncology Business Group, Chairman and CEO EMEA.

***ENDS***

Notes to Editors

Eribulin

Eribulin is also indicated for the treatment of women 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.[8]

About Soft Tissue Sarcomas

Soft tissue sarcoma is a collective term for a diverse group of malignant tumours. Only 50% of people with soft tissue sarcomas are expected to live five years.[9]

Unlike other cancers such as non-small cell lung cancer (NSCLC), soft tissue sarcomas are mostly diagnosed with localised disease, and many are amenable to complete surgical removal, yet relapse rates can be as high as 50 percent.[10] Outcomes for patients with advanced disease are poor, with median survival around one year or less. Due to the rarity of these tumours, evidence for prognostic factors is weak and not well understood.[11]

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 multiple 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 www.eisai.com.

References

[1]Schöffski P et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. The Lancet. 2016

[2]C Stiller. Descriptive epidemiology of sarcomas in Europe: report from the RARECARE project. Available at http://www.ncbi.nlm.nih.gov/pubmed/23079473 Accessed April 2016

[3]Cancer Research UK, Soft Tissue Sarcoma Incidence Statistics. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/soft-tissue-sarcoma/incidence/. Accessed: April 2016

[4]Macmillan. What are soft tissue sarcomas? Available at: http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Softtissuesarcomas/Aboutsofttissuesarcomas/Softtissuesarcomas.aspx. Accessed: April 2016

[5]ESMO Guidance. Available at: http://annonc.oxfordjournals.org/content/25/suppl_3/iii102.full.pdf+html Accessed: April 2016

[6]Kawano S, et al. Antimitotic and Non-mitotic Effects of Eribulin Mesilate in Soft Tissue Sarcoma. Anticancer Research 2016; 36; 1553-1562

[7]Kevin L Bennewith and Shoukat Dedhar. Targeting hypoxic tumour cells to overcome metastasis. BMC Cancer 2011;11:504

[8] 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: April 2016

[9] National Cancer Institute - http://www.cancer.org/cancer/sarcoma-adultsofttissuecancer/detailedguide/sarcoma-adult-soft-tissue-cancer-survival-rates

[10] R Pollock. Soft Tissue Sarcomas, A Volume in the American Cancer Society Atlas of Clinical Oncology Series. 2012

[11] Fletcher, et al. World Health Organization Classification of Tumours of Soft Tissue and Bone (4th Edition). Lyon: IARC Press, 2013

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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.

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