FDA approves Yondelis (trabectedin to treat soft tissue sarcomas- Janssen Biotech + PharmaMar
The FDA has approved Yondelis (trabectedin), a chemotherapy from Janssen Biotech + PharmaMar, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline.
The effectiveness and safety of trabectedin were demonstrated in 518 clinical trial participants with metastatic or recurrent leiomyosarcoma or liposarcoma. Participants were randomly assigned to receive either trabectedin (345 patients) or dacarbazine (173 patients), another chemotherapy drug. Participants who received trabectedin experienced a delay in the growth of their tumour (progression-free survival), which occurred on average about 4.2 months after starting treatment, compared to participants assigned to dacarbazine, whose disease progressed an average of 1.5 months after starting treatment.
Comment: This drug was approved for this indication in the EU in 2007.
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