FDA Approves Janssen’s Yondelis

The FDA approved Janssen Products’ Yondelis (trabectedin), a chemotherapy to treat two soft tissue sarcomas — liposarcoma and leiomyosarcoma — that can’t be removed by surgery or are advanced.

The treatment is approved for patients who have received chemotherapy that contained anthracycline. Approval was based on a clinical trial showing patients who received Yondelis saw tumor growth delayed a little more than four months, compared with 1.5 months in the control arm.

Yondelis carries a warning of risk of severe and fatal infections, muscle tissue breakdown, leakage around the vein or catheter, tissue necrosis and heart failure. In 2014, an estimated 12,000 cases of STS were diagnosed in the U.S.