IQWiG's negative view on Halaven bewilders Eisai

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) 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 Japan’s Eisai (TYO: 4523) 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, the IQWiG ignores pivotal Phase III data which demonstrated clearly that eribulin is the first and only single agent therapy to show a statistically significant overall survival advantage in advanced liposarcoma, said Eisai.

"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.