Janssen’s Yondelis receives US FDA nod to treat patients with unresectable/metastatic LPS or LMS

The US Food and Drug Administration (FDA) has approved Janssen Biotech Inc’s Yondelis (trabectedin) for the treatment of patients with unresectable (unable to be removed with surgery) or metastatic liposarcoma (LPS) or leiomyosarcoma (LMS) who received a prior anthracycline-containing regimen.

The approval was based on recently published clinical efficacy and safety data from the phase 3, randomized, open-label, controlled study (ET743-SAR-3007), which evaluated Yondelis versus the chemotherapy agent dacarbazine, in patients with unresectable or metastatic LPS or LMS previously treated with an anthracycline and at least one additional chemotherapy regimen.

While approved for both LPS and LMS, Yondelis is the first treatment to be specifically approved for LPS in the US.