YONDELIS(Trabectedin) Single Patient Compassionate Use / Expanded Access in Soft Tissue Sarcoma
The single patient treatment instructions for use are intended for a single patient with
advanced soft tissue sarcoma. The patient will be treated with YONDELIS® (trabectedin) i.v.
formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on Day 1 every 21 days, provided that
he/she fulfills all eligibility criteria.
The patient may continue to receive therapy until there is evidence of disease progression
or unacceptable toxicity. Safety will be evaluated and serious adverse events will be
reported. Disease assessments will occur according to institutional practice.
John C. Bagwell, MD
University of Texas
United States: Food and Drug Administration
05- EAP- STS
|University of Texas Southwestern||Dallas, Texas 75390|