German Institute for Quality and Efficiency in Health Care suggests no additional benefit of Halaven (eribulin) in liposarcomas- 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), from Eisai, 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.

However Eisai claims that IQWiG ignores pivotal phase III data which demonstrated clearly that eribulin is the only single agent therapy to show a statistically significant overall survival advantage in advanced liposarcoma. The final decision on the additional benefit of eribulin lies with the G-BA and is expected for the end of December 2016, following consideration of all relevant aspects of the IQWiG report, written statements and an oral hearing of experts and patient representatives.

Comment: In study 309, the pivotal phase III trial on which the indication approval was based, eribulin was the first and only single agent therapy to demonstrate a significant survival advantage in advanced liposarcoma. Results from Study 309 showed that patients treated with eribulin compared to those treated with dacarbazine, a longstanding established and internationally accepted treatment option, benefitted from a median 7.2 month increase in overall survival for the pre-specified subgroup of patients with unresectable advanced or metastatic liposarcoma (15.6 months versus 8.4 months). In this study, the most common adverse events observed in the eribulin arm were neutropenia, fatigue, nausea, alopecia and constipation, which is consistent with the known safety profile of eribulin. The most common adverse events observed in the dacarbazine arm were nausea, fatigue, anemia, thrombocytopenia and constipation.