The Australian TGA approves Yondelis® (trabectedin) for Soft Tissue Sarcoma (Liposarcoma or Leiomyosarcoma)

PharmaMar (MSE:PHM) has announced today 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 3, 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. Luis Mora, Managing Director of PharmaMar, said: “the approval in Australia will allow more patients with this disease to have access to a drug that will address an unmet medical need.” Associate Professor Jayesh Desai, Medical Oncologist at the Peter MacCallum Cancer Centre in Melbourne, Australia, and Deputy-Chair of the Australia New Zealand Sarcoma Association (ANZSA), said: “Sarcoma is a relatively rare cancer and treatment options are limited for those with advanced disease,” and added: “We welcome news that this therapy is formally approved for use in Australia and look forward to seeing advanced sarcoma patients being provided additional benefit.”

The release as fetched from its publisher. pharmamar.com ↗