Eisai’s Halaven recommended for EU approval as liposarcoma therapy

Eisai's cancer drug Halaven has been recommended for European regulatory approval as a treatment for advanced liposarcoma.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the approval of the drug for the treatment of adult patients with unresectable liposarcomas who have been previously treated.

Halaven is the first and only single agent to demonstrate an overall survival benefit in a phase III trial in patients with advanced, recurrent or metastatic soft tissue sarcoma, with data from this study helping to support the EU regulatory application.

The drug is already approved for the treatment of metastatic breast cancer in the EU, making this the second indication for which Halaven has received a positive CHMP opinion based on a statistically significant extension of overall survival.

The company said: "Eisai aims to enhance the clinical value of Halaven to contribute further toward addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families and healthcare providers."

Approximately 29,000 patients in Europe are diagnosed with soft tissue sarcoma each year, with liposarcoma being one of the most common forms.