Thailand Approves Trabectedin for Advanced Soft Tissue Sarcoma

Specialised Therapeutics, which announced the approval on November 15, said the decision was supported by a Phase 3 trial comparing trabectedin with dacarbazine in patients with unresectable or metastatic liposarcoma or leiomyosarcoma who had previously received an anthracycline and at least one other chemotherapy regimen.

In the study, median progression-free survival was 4.2 months with trabectedin, compared with 1.5 months with dacarbazine. The difference was statistically significant (hazard ratio 0.55; p<0.001), corresponding to a 45% lower risk of disease progression or death. Grade 3 or 4 adverse reactions occurred in fewer than one-third of patients. Common reactions included neutropenia, nausea, vomiting, elevated liver enzymes, anaemia, fatigue, thrombocytopenia, reduced appetite and diarrhoea.

Soft tissue sarcoma is rare in Thailand, with an age-standardized incidence of 2.14 cases per 100,000 person-years. The most frequently reported subtypes are unspecified sarcoma (24.8%), leiomyosarcoma (19.0%) and liposarcoma (11.4%). The reported five-year relative survival rate is 62.6%, although the company said specialised options remain needed when cancer progresses or returns after initial treatment.

Under an exclusive licensing agreement with PharmaMar S.A., Specialised Therapeutics will handle YONDELIS’s regulatory affairs, commercialization, distribution and medical engagement in Thailand. The medicine can cause severe bone marrow suppression and requires blood-count and liver-function monitoring; it is contraindicated in patients with concurrent serious or uncontrolled infections.