Additional benefit of Halaven in Breast Cancer confirmed by G-BA - Eisai
The German Federal Joint Committee (G-BA) has confirmed that the largest defined patient group has "considerable" additional benefit of Halaven (eribulin), from Eisai, versus certain comparator therapies for the treatment of women with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. This reassessment follows a 2012 finding that the drug offers no clear added benefit to these patients.
The reassessment for eribulin is based on clinical evidence derived from two global Phase III trials; EMBRACE (Study 305) and Study 301. These studies involved more than 1,800 women. In line with the G-BA requirements, additional pooled analyses of data were specifically performed for the benefit assessment procedure in Germany and reviewed by IQWiG.
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