Considerable Additional Benefit of Eisai's Halaven® (eribulin) in Advanced Liposarcoma Confirmed by the German Federal Joint Committee (G-BA) - Seite 2

The G-BA assessment was supported by data from study 309, a randomized phase III trial in unresectable advanced or metastatic pretreated leiomyosarcoma or liposarcoma patients. The results showed that eribulin significantly improves overall survival (OS) versus dacarbazine in a preplanned subgroup analysis of patients with advanced liposarcoma. In this study, patients with liposarcoma that were treated with eribulin had a 7.2 months longer median overall survival than those treated with dacarbazine (15.6 months versus 8.4 months median OS, HR = 0.511; 95% CI 0.346-0.753; p=0.0006).^[1] The most common (above 5%) adverse events of Grade 3 or 4 observed in the eribulin arm were neutropenia, anaemia and leukopenia, and in the dacarbazine arm were anaemia, neutropenia and thrombocytopenia.^[1]

"We are pleased that the G-BA - the supreme decision making body in German statutory healthcare - recognised the considerable value eribulin brings to people with unresectable advanced or metastatic liposarcoma compared to dacarbazine. Advanced liposarcoma is the second tumour type in which eribulin has demonstrated an overall survival benefit. We believe eribulin offers an unprecedented benefit to patients in Germany, and look forward to positive talks with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) to negotiate reimbursement prices based on this favourable G-BA decision," comments Dr. Patrik Höller, Director Oncology Business Group, Eisai GmbH, Frankfurt, Germany.

Eribulin is also licensed in the European Union 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.^[3]

Eisai is dedicated to the discovery, development and production of 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 to better understand 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.