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YONDELIS (trabectedin), alkaloid antineoplastic agent
Reason for request
Low clinical benefit in advanced soft tissue sarcoma and no improved clinical benefit demonstrated compared to supportive care.
YONDELIS has MA in adults with advanced soft tissue sarcoma (main data in liposarcoma and leiomyosarcoma), after failure of anthracycline and ifosfamide-based treatments, or in patients not eligible to receive these medicinal products.
The data demonstrate the absence of superiority from YONDELIS versus dacarbazine on overall survival in this population of patients.
No benefit on mortality has been demonstrated to date, or versus supportive care or versus the alternatives available in the absence of direct comparison.
The role of YONDELIS compared to the alternatives is not known in this indication.
Clinical Benefit
| Low |
- |
Clinical Added Value
| no clinical added value |
Au regard des nouvelles données comparatives de l’étude TSAR démontrant un gain faible de YONDELIS en termes de survie sans progression par rapport aux soins de support (différence absolue de 1,6 mois) et sans gain en survie globale, la Commission considère que YONDELIS n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux soins de support dans le traitement du sarcome des tissus mous au stade avancé. |
Therapeutic use
- |
