Yondelis approved by TGA in Australia to treat unresectable or metastatic liposarcoma (LPS) or leiomyosarcoma.- Specialised Therapeutics.

PharmaMar has announced that its licensing partner, Specialised Therapeutics Asia, Pte. Ltd. (STA) has received marketing approval for Yondelis (trabectedin) by the Australian Therapeutic Goods Administration (TGA) for the treatment of patients with unresectable or metastatic liposarcoma (LPS) or leiomyosarcoma (LMS), who have received a prior anthracycline-containing regimen. The approval was based on the clinical efficacy and safety data from a Phase III, randomized, open-label, controlled study, ET743-SAR-3007, which evaluated trabectedin versus dacarbazine in this patient population. This pivotal trial confirmed the results of previous clinical studies and provides strong evidence of the clinical benefit of trabectedin. In October 2019, PharmaMar and STA signed an agreement to commercialize trabectedin in Australia, New Zealand and South East Asia.