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Biopharmaceuticals Oncology Regulatory

 News Release - April 23, 2021

GLOBAL Sarcoma Therapy Now Approved for Australian Patients

Globally regarded soft tissue sarcoma therapy has been approved by the Therapeutic Goods Administration for Australian patients

YONDELISÒ (trabeCTedin) demonstrates 45% reduCTion in risk of disease progression or death versus dacarbazine1


SINGAPORE, April 23, 2021 -- (Healthcare Sales & Marketing Network) -- 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 patients who might benefit."

STA markets YONDELIS under an exclusive license arrangement with international partner, PharmaMar.

About Specialised Therapeutics Asia

Headquartered in Singapore, Specialised Therapeutics Asia Pte Ltd (STA) is an international biopharmaceutical company established to commercialise new therapies and technologies to patients throughout South East Asia, as well as in Australia and New Zealand. STA and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affeCTed by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care.

Additional information can be found at www.stbiopharma.com

About PharmaMar

Headquartered in Madrid, PharmaMar is a biopharmaceutical company focused on oncology and committed to research and development, taking its inspiration from the sea to discover molecules with antitumor aCTivity. It is a company seeking innovative produCTs to provide health care professionals with new tools to treat cancer. Its commitment to patients and to research has made it a world leader in the discovery of antitumor drugs of marine origin.

PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes YONDELISÒ in Europe and has other clinical stage programs under development for several types of solid cancers: lurbineCTedin (PM1183), PM184 and PM14.

About YONDELIS® (trabeCTedin)

YONDELIS® (trabeCTedin) is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, ECTeinascidia turbinata. The anti-cancer medicine works by preventing tumor cells from multiplying and is approved in 76 countries in North America, Europe, South America and Asia for the treatment of advanced soft-tissue sarcomas as a single-agent, and in 69 countries for relapsed ovarian in combination with DOXIL®/CAELYX® (doxorubicin HCl liposome injeCTion).

The approval was based on the results of a pivotal phase 3, randomised, open-label controlled study which evaluated YONDELIS versus dacarbazine in over 500 patients with unreseCTable or metastatic liposarcoma (LPS) or leiomyosarcoma (LMS) previously treated with an anthracycline and at least one additional chemotherapy regimen. LPS and LMS are subtypes of soft tissue sarcoma (STS) and represent more than 35% of all STS cases.5

The median progression-free survival (PFS) among the YONDELIS treatment group was 4.2 months compared to 1.5 months in the dacarbazine treatment group, representing a 45% reduCTion in the risk of disease progression or death with YONDELIS (HR=0.55; 95% CI: 0.44 - 0.70; p<0.001).1

Among the 340 patients who received YONDELIS and were included in the safety analysis in the randomised trial, the most common (≥20%) adverse reaCTions were nausea (73%), fatigue (67%), vomiting (44%), constipation (36%), decreased appetite (34%), diarrhoea (34%), dyspnoea (25%), peripheral oedema (24%) and headache (23%). The most common (≥20%) laboratory abnormalities were neutropenia (49%), increased alanine transaminase (ALT) (45%), anaemia (39%), increased aspartate aminotransferase (AST) (35%), thrombocytopaenia (30%) and increased blood alkaline phosphatase (20%).1

About Soft Tissue Sarcoma

Soft tissue sarcoma is a rare type of cancer that forms as a painless lump (tumour) in any one of the soft tissues conneCTing all the organs and body struCTures – including fat, muscle, nerves, deep skin tissue, blood vessels and the tissue surrounding joints (synovial tissue). Soft tissue sarcomas commonly develop in the thigh, shoulder and pelvis and may sometimes develop in the abdomen or chest.6

Metastatic or locally advanced STS is generally considered incurable, with the mainstay of treatment being systemic chemotherapy. For some patients with limited disease burden however, long-term remission can be achieved through a multimodality approach involving medical, surgical and radiation therapy.6

Further Enquiries

Emma Power, Corporate Affairs and Communications Manager, Specialised Therapeutics Asia +65 3158 9940 or +61 419 149 525 or epower@stbiopharma.com

References
  1. Demetri G. et al. J Clin Oncol. 2016; 34(8): 786-793
  2. YONDELIS (trabeCTedin) TGA Approved ProduCT Information
  3. Barone A. et al. Clin Cancer Res; 2017; 23(24): 7448-7453
  4. YONDELIS (trabeCTedin) European Medicines Agency Summary of ProduCT CharaCTeristics
  5. Toro JR, et al. Int J Cancer. 2006; 119:2922-2930
  6. Cancer Council ViCToria FaCT Sheet - Soft tissue sarcoma. Available at https://www.cancervic.org.au/cancer-information/types-of-cancer/soft_tissue_cancers/soft-tissue-cancers-overview.html


Source: Specialised Therapeutics Asia

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