Posted by Michael Wonder on 06 Dec 2016
Considerable additional benefit of Eisai's Halaven (eribulin mesylate) in advanced liposarcoma confirmed by the German Federal Joint Committee
4 December 2016 - Eribulin mesylate has shown unprecedented survival benefit in advanced liposarcoma in pivotal phase III trial.
The German Federal Joint Committee (G-BA) has confirmed the considerable additional benefit for Halaven (eribulin mesylate) compared to dacarbazine in the treatment of unresectable advanced or metastatic liposarcoma.
In its assessment, the G-BA found the data for mortality, symptoms and quality of life, which showed an additional benefit over the appropriate comparator, to be decisive. With its decision, the G-BA did not follow the recommendation of the German Institute for Quality and Efficiency in Health Care (IQWiG) - put forward in September this year - to not grant an additional benefit based on formal grounds only which resulted in the IQWiG not evaluating the clinical data provided by Eisai initially.
In contrast, the G-BA judged the substantial survival benefit eribulin mesylate offers to patients with advanced liposarcoma to be a clinically relevant and considerable improvement of the therapy-relevant benefit.
