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

Madrid, April 23rd, 2021. - 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."

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About PharmaMar

PharmaMar is a biopharmaceutical company focused on the research and development of new oncology treatments, whose mission is to improve the healthcare outcomes of patients afflicted by serious diseases with our innovative medicines. The Company is inspired by the sea, driven by science, and motivated by patients with serious diseases to improve their lives by delivering novel medicines to them. PharmaMar intends to continue to be the world leader in marine medicinal discovery, development and innovation.

PharmaMar has developed and now commercializes Yondelis® in Europe by itself, as well as Zepzelca® (lurbinectedin), in the US; and Aplidin® (plitidepsin), in Australia, with different partners. In addition, it has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar has other clinical-stage programs under development for several types of solid cancers: lurbinectedin, PM184 and PM14. Headquartered in Madrid (Spain), PharmaMar has subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar also wholly owns other companies: GENOMICA, a molecular diagnostics company; and Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.

About Yondelis®

Yondelis® (trabectedin) is a novel, synthetically produced antitumor agent originally isolated from Ecteinascidia turbinata, a type of sea squirt. Yondelis® exerts its anticancer effects primarily by inhibiting active transcription, a type of gene expression on which proliferating cancer cells are particularly dependent.

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Pharma Mar SA published this content on 23 April 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 23 April 2021 06:43:00 UTC.