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Eisai “cannot understand” German agency’s recommendation to reject Halaven

Published on 06/09/16 at 08:36am

Eisai has issued a statement to declare their “bewilderment” following a decision from the German Institute for Quality and Efficiency in Health Care (IQWiG), the equivalent of NICE in the UK, not to recommend Halaven (eribulin) versus established therapies for unresectable advanced or metastatic liposarcomas.

Liposarcomas are a common subset of soft tissue sarcomas, which originate in fat cells and can occur anywhere in the body. Sarcomas represent around 1% of all cancers diagnosed in Europe and 3,000 people in Germany are diagnosed with soft tissue sarcomas each year.

The Japanese company have expressed extreme shock with their opinion that on formal or methodological grounds, respectively, no additional benefit has been proven for Halaven. This is despite their submission of Phase III data directly comparing the drug to dacarbazine, as well as an indirect comparison to Yondelis (trabectedin).

Although the final decision on the drug will made by the Federal Joint Committee (G-BA), the IQWiG’s opinion usually plays a strong role in the decision.

According to Eisai, these comparisons “demonstrate clearly” that Halaven is the first and only single agent therapy to show a statistically significant overall survival advantage in advanced liposarcoma. Results from the Phase III Study 309 showed a median 7.2 month increase in overall survival for Halaven versus dacarbazine.

Dr Helga Schmitz, medical director at Eisai HmbH, says: “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 treatments, such as eribulin.”

Dr Patrik Höller, director of oncology business group at Eisai GmbH, adds: “Eisai cannot understand the suggestion of the IQWiG that no additional benefit has been proven for eribulin, despite compelling Phase III data which show an overall survival benefit. We are hopeful that, notwithstanding the report by IQWiG, the G-BA will take a more informed view.”

Halaven was recommended by the EU for approval earlier this year.  

Sean Murray

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