PharmaMar has announced that its licensing partner, Janssen Biotech, Inc. received marketing approval for trabectedin (Yondelis) by the US Food and Drug Administration (FDA) for the treatment of patients with unresectable or metastatic liposarcoma (LPS) or leiomyosarcoma (LMS) who have received a prior anthracycline-containing regimen.

LPS and LMS are among the most common types of soft tissue sarcoma and this is the first treatment to be specifically approved for LPS in the US.

The approval was based on the clinical efficacy and safety data from a recently published Phase 3, randomised, open-label, controlled study, ET743-SAR-3007, which evaluated trabectedin versus dacarbazine in this patient population¹.

This trial confirmed the results of previous clinical studies and provides strong evidence of the clinical benefit of trabectedin.

Reference

Demetri, von Mehren, Jones et al. (2015) Efficacy and safety of trabectedin or dacarbazine for metastatic liposarcoma or leiomyosarcoma after failure of conventional chemotherapy: Results of a phase III randomized multicenter clinical trial, Journal of Clinical Oncology

Source: PharmaMar