FDA approves Janssen’s Yondelis chemotherapy to treat advanced soft tissue sarcomas

ondelis is approved for patients with two forms of STS, liposarcoma or leiomyosarcoma, who had earlier received chemotherapy that contained anthracycline.

While it is approved for both leiomyosarcoma and metastatic liposarcoma (LPS), Yondelis is the first treatment to be specifically approved for LPS in the US.

Janssen said since the drug’s first approval in Europe in 2007, about 50,000 patients in around 80 countries have benefited from the therapy across all indications.

The FDA expanded the drug’s labeling based on a clinical trial demonstrating its safety and effectiveness in 518 patients with metastatic or recurrent leiomyosarcoma or liposarcoma.

Patients who took Yondelis had cancer progression halted for an average of 4.2 months, compared to an average of 1.5 months among those who took another anti-cancer drug.

The recommended dose of Yondelis is 1.5 mg/m2 administered as an intravenous infusion over 24 hours via a central venous line every 21 days until disease progression or unacceptable toxicity in patients with normal bilirubin and aspartate aminotransferase or alanine transaminase, less than or equal to 2.5 times the upper limit of normal.

FDA center for drug evaluation and research director of the office of hematology and oncology products Richard Pazdur said: "The treatment of advanced or metastatic soft tissue sarcoma represents a difficult challenge with few effective therapeutic choices available for patients.

"Today’s approval of Yondelis provides a treatment option for advanced or metastatic liposarcoma and leiomyosarcoma."