Globally regarded soft tissue sarcoma therapy has been approved by the Therapeutic Goods Administration for Australian patientsYONDELISÒ (trabectedin) demonstrates 45% reduction in risk of disease progression or death versus dacarbazine1
SINGAPORE, April 23, 2021 /PRNewswire/ — A GLOBAL sarcoma therapy shown to improve progression free survival1 has been approved for Australian patients by the country’s peak medicines regulatory agency.
The Therapeutic Goods Administration has approved the use of YONDELIS (trabectedin), marketed by Specialised Therapeutics, “for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen”.2
News of the TGA registration has been welcomed by leading doctors and the Australian sarcoma community, who say it means patients whose disease has progressed will have access to a new line of therapy.
“Sarcoma is a relatively rare cancer and treatment options are limited for those with advanced disease,” said 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)
“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.”
YONDELIS is already approved and has been available to patients in the United States since 2015,3 and in Europe since 2007.4
STA Chief Executive Officer Mr Carlo Montagner said TGA registration was a first step, with the company now seeking to have YONDELIS made affordable for all eligible Australian patients via a listing on the Pharmaceutical Benefits Scheme.
A reimbursement submission is expected to be considered at the July 2021 meeting of the Pharmaceutical Benefits Advisory Committee. In the interim, YONDELIS is being made available to Australian patients under a Co-Pay Special Access Program.
Mr Montagner commented: “We are pleased to successfully register YONDELIS in Australia, after being initially approached by oncologists and patient groups to bring YONDELIS to this country.
“Prior to our involvement, YONDELIS was only available internationally and was being imported by hospitals at great cost with complex logistics.
“We look forward to continuing our work with the sarcoma community to ensure that this therapy is not only available, but is affordable for all appropriate