Global Sarcoma Therapy Now Available in Thailand - Specialised Therapeutics

• by Specialised Therapeutics
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• Approval of YONDELIS^® (trabectedin) by the Thai FDA for patients who have failed prior treatment with anthracyclines and ifosfamide or for those who are unsuited to receive these agents¹
• YONDELIS provides an additional treatment option for Thai adults diagnosed with advanced soft tissue sarcoma
• Eligible adult patients in Thailand with advanced soft tissue sarcoma will have access to YONDELIS from 1st December 2026

Singapore, 16 November 2026:

Independent biopharmaceutical company Specialised Therapeutics today announced that the Thailand Food and Drug Administration approved YONDELIS^® (trabectedin) on 24 July 2026 for the treatment of adult patients with advanced soft tissue sarcoma (STS).¹

The regulatory approval grants access to YONDELIS for patients who have failed prior treatment with anthracyclines and ifosfamide, or for those who are unsuited to receive these agents.¹ The approval is based on the clinical efficacy and safety data from the Phase 3, randomized, open-label, controlled study (ET743-SAR-3007), which evaluated YONDELIS versus the chemotherapy agent dacarbazine in patients with unresectable or metastatic liposarcoma or leiomyosarcoma previously treated with an anthracycline and at least one additional chemotherapy regimen.^2,3

In the pivotal Phase 3 clinical trial, patients treated with YONDELIS achieved a statistically significant improvement in median progression-free survival (PFS) of 4.2 months versus 1.5 months for trabectedin vs dacarbazine HR, 0.55; p<0.001, representing a 45% reduction in the risk of disease progression or death.²

YONDELIS demonstrated a manageable safety profile, with severe (Grade 3 or 4) adverse reactions occurring in less than one-third of patients. The most common adverse reactions of any severity grade included neutropenia, nausea, vomiting, elevated liver enzymes (AST/ALT), anaemia, fatigue, thrombocytopenia, decreased appetite, and diarrhoea.^1,2

YONDELIS is an established antineoplastic agent originally derived from the sea squirt (Ecteinascidia turbinata). It exerts the anti-tumor effect by binding to the minor groove of DNA, disrupting the cell cycle and preventing cancer cells from multiplying.⁴

STS is a rare and complex disease. In Thailand, the age-standardized incidence rate of STS is 2.14 per 100,000 person-years, which is relatively low compared to Western nations. The most frequently reported histological subtypes among Thai patients are unspecified sarcoma (24.8%), leiomyosarcoma (19.0%), and liposarcoma (11.4%). While current healthcare treatments yield a five-year relative survival rate of 62.6% for soft tissue sarcoma in Thailand, there remains a critical need for advanced, specialised therapies for patients whose cancer progresses or relapses after initial care.⁵

Carlo Montagner, CEO, Specialised Therapeutics, commented:

“The approval of YONDELIS in Thailand expands access to a recognized, international standard-of-care therapy for patients living with advanced STS. STS remains a complex disease with limited treatment options once initial therapies fail. Securing regulatory approval in Thailand aligns with our core mission to address unmet medical needs and deliver specialised oncology therapies across South East Asia.”

Under an exclusive licensing agreement with global partner PharmaMar S.A., Specialised Therapeutics will be responsible for all regulatory, commercialisation, distribution, and medical engagement operations for YONDELIS in Thailand.

 

Ends.

 

Further Enquiries: Kellie Penrose kpenrose@stbiopharma.com

 

About Specialised Therapeutics

Specialised Therapeutics (ST) is an international biopharmaceutical company dedicated to commercializing novel, high-value therapies and diagnostic technologies across Australia, New Zealand, and South East Asia. ST collaborates with leading global biopharmaceutical partners to deliver healthcare solutions where there is an unmet clinical need. For additional information, visit www.stbiopharma.com.

 

About PharmaMar

Headquartered in Spain, 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.

For more information, please visit: www.pharmamar.com

 

About YONDELIS^® (trabectedin)

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.⁶

 

Important Safety Information on YONDELIS

YONDELIS is contraindicated in patients with concurrent serious or uncontrolled infections. Patients who develop a fever should promptly seek medical attention so active supportive therapy can be started immediately. Women of childbearing potential must use highly effective contraception during treatment and 8 months thereafter and immediately inform the treating physician if a pregnancy occurs. Men of fertile age must use highly effective contraception during treatment and 5 months after treatment.^1,2

In clinical trials, the most common adverse reactions of any severity grade were neutropenia, nausea, vomiting, increased liver enzymes (AST/ALT), anaemia, fatigue, thrombocytopenia, anorexia, and diarrhoea. Less than one-third of patients experienced serious adverse reactions of Grade 3 or 4 severity. Fatal adverse reactions occurred in 1.9% of patients and were often the result of combined events including pancytopenia, febrile neutropenia, sepsis, hepatic involvement, multiorgan failure, and rhabdomyolysis.²

Treatment with YONDELIS can cause severe myelosuppression, including Grade 3 or 4 neutropenia and thrombocytopenia. A full blood cell count including differential and platelet count must be performed at baseline, weekly for the first two cycles, and then once between cycles. Liver function tests and creatinine clearance must also be closely monitored prior to and during treatment to manage the risks of hepatotoxicity and renal impairment.

YONDELIS is a prescription medicine and can only be prescribed by a doctor. For more information about YONDELIS, or advanced STS, please see your health care professional.

 

References

1. YONDELIS^® (trabectedin) Thai FDA Product Information. (Link)
2. Demetri GD, von Mehren M, Jones RL, et al. J Clin Oncol. 2016; 34(8):786-793.
3. NCCN Clinical Practice Guidelines in Oncology. Soft Tissue Sarcoma. Version 5.2026
4. D’Incalci M, Galmarini CM. Mol Cancer Thera 2010; 9(8): 2157-2163.
5. Klangjorhor J, Pongnikorn D, Sittiju P et al. Scientific Reports 2022; 12:12824
6. Brodowicz T. Trabectedin in Soft Tissue Sarcoma. Future Oncol. 2014; 10(8):1–5