Eisai files for soft tissue sarcoma approval of Halaven

Eisai has submitted regulatory applications for its drug Halaven to be approved as a treatment for soft tissue sarcoma.

Applications have been submitted simultaneously in the US, EU and Japan for the eribulin mesylate therapy to be approved as a treatment for patients with inoperable soft tissue sarcoma who have received prior chemotherapy for advanced or metastatic disease.

Data from a previous phase III clinical trial, Study 309, has demonstrated the overall survival benefits the drug can deliver in this indication.

Halaven was first approved for the treatment of metastatic breast cancer in the US in November 2010, and is currently available in approximately 60 nations, including Japan and countries in Europe, the Americas and Asia. 

The therapy has been designated as an orphan drug for the treatment of soft tissue sarcoma in the US and Japan.

Kenichi Nomoto, president of the oncology product creation unit at Eisai Product Creation Systems, said: "These regulatory submissions signify the potential for an additional treatment option for patients with this difficult-to-treat disease, an important milestone for physicians and patients."