Eisai’s Halaven gains positive CHMP opinion for advanced liposarcoma

Eisai’s Halaven has received a positive opinion from the Europe’s key medicines approval committee for its use in unresectable advanced or metastatic liposarcoma following the results from phase 3 data.

The new approval is good news for Eisai and Halaven, which needs to expand beyond its existing licence in breast cancer in order to increase revenues.

The decision takes Halaven one step closer to European approval. Halaven gained FDA approval for liposarcoma treatment in January, and in Japan with a similar licence the following month.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) ruling released on Friday was based on median overall survival from a phase 3 trial of patients taking Halaven as a second line monotherapy for the rare cancer.

This showed a 7.2 months increased overall survival compared to dacarbazine, a very significant increase over the older treatment. A lower median overall survival increase of 2.6 months was seen in a pooled group across patients with liposarcomas and leimyosarcomas.

Halaven now becomes the first single agent treatment shown to significantly increase survival in liposarcoma – a disease that, although incredibly rare, (approximately 1% of all cancers diagnosed in Europe every year) has a five-year survival of around 50%.

“This positive opinion is welcomed by sarcoma specialists in Europe, who have few options to treat these patients,” said Head of the Department of General Medical Oncology, University Hospitals Leuven, Belgium, Patrick Schöffski. “These data are a clinically meaningful result given the significant unmet need.”

Gary Hendler, chairman and CEO of Eisai EMEA, echoed Schöffski’s emphasis on the lack of options for liposarcoma: “For the first time, people with liposarcoma, a rare and difficult to treat cancer, have an option that can significantly extend their lives.”

The new licence is for adult patients with unresectable liposarcomas who have previously received anthracycline therapy for advanced or metastatic disease.

In the UK, the drug has had a rocky ride so far. Halaven was dropped from the UK’s Cancer Drugs Fund list at the beginning of 2015 before a successful appeal from Eisai had it reinstated. NHS Scotland’s Scottish Medicine Consortium (SMC) also turned down the drug in August citing an uncertainty of the benefits of the drug.

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