4 September 2016 - Assessment ignores unprecedented overall survival benefit for eribulin in advanced liposarcoma.

The German Institute for Quality and Efficiency in Health Care (IQWiG) has published a report which suggests that on formal or methodological grounds, respectively, no additional benefit has been proven for Halaven (eribulin mesylate) versus established comparator therapies - as defined by the Federal Joint Committee (G-BA) - for the treatment of unresectable advanced or metastatic liposarcomas.

The dossier submitted by Eisai for the assessment included a direct comparison to dacarbazine (based on Eisai's phase III study 309) as well as an indirect comparison to trabectedin. With its suggestion, IQWiG ignores pivotal phase III data which demonstrated clearly that eribulin mesylate is the first and only single agent therapy to show a statistically significant overall survival advantage in advanced liposarcoma.

"Eribulin has demonstrated a statistically significant survival advantage over dacarbazine in the treatment of advanced liposarcoma. This is a very rare and difficult to treat type of soft tissue sarcoma for which treatment options are few and existing therapies are associated with only limited efficacy. The clinical importance of this unprecedented survival benefit cannot be overstated for people who live with advanced liposarcoma and urgently need new and effective treatment options, such as eribulin," comments Dr. Helga Schmitz, Medical Director, Eisai GmbH.

The final decision on the additional benefit of eribulin lies with the G-BA and is expected for the end of December 2016, following due and balanced consideration of all relevant aspects of the IQWiG report, written statements and an oral hearing of experts and patient representatives.

Read Eisai press release