Germany’s IQWiG has concluded that Eisai’s breast cancer drug Halaven (erbulin mesylate) does indeed offer a benefit over other comparators on the market, but only in a restricted group of patients with the disease.

After a second review of available data the Institute said the drug’s survival benefit outweighed its nasty side effects in patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen. But only in those who can no longer be treated with taxanes or anthracyclines, substantially squeezing its target population.

The reassessment is based on clinical data from two global Phase III trials; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice Versus E7389) and Study 301, involving more than 1,800 women. EMBRACE showed that Halaven prolonged median overall survival in heavily pre-treated women with metastatic breast cancer by 2.7 months versus those receiving a ‘Treatment of Physician's Choice’. 

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 the Institute, Eisai said, noting that it is “pleased that IQWiG has at least in part, and for the majority of patients acknowledged the additional benefit that Halaven may offer to women with metastatic breast cancer”.

For more details, go to: http://www.pharmatimes.com/Article/14-11-04/Germany_s_IQWiG_finds_some_benefit_in_Eisai_s_Halaven.aspx