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Eisai receives EU approval for Halaven in advanced liposarcoma
Eisai has announced that its multipurpose cancer therapy Halaven has been approved in a new indication.
The European Commission has approved the anticancer agent for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy for advanced or metastatic disease.
It is the first and only single agent to demonstrate a statistically significant overall survival benefit in a phase III trial in patients with advanced, recurrent or metastatic soft tissue sarcoma.
Around 29,000 European patients are diagnosed with soft tissue sarcoma each year, or about one percent of all cancers diagnosed in Europe. Outcomes associated with the condition are generally poor, creating an unmet need for new therapy options.
Following the drug's approval for use in the treatment of metastatic breast cancer, this marks the second indication in which Halaven has received approval after showing overall survival benefits.
It is approved for use in the treatment of breast cancer in approximately 60 countries. The drug is also currently under review for soft tissue sarcoma in Switzerland, Russia, Australia, Brazil and Malaysia.
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