The Food and Drug Administration (FDA) has approved Yondelis (trabectedin; Janssen) for the treatment of patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.
The approval is based on clinical trial data of 518 patients with metastatic or recurrent leiomyosarcoma or liposarcoma who were randomly assigned to receive Yondelis or dacarbazine. Patients receiving Yondelis experienced improved progression-free survival compared to those receiving dacarbazine (4.2 months vs. 1.5 months, respectively).
Yondelis carries a warning on the risk of neutropenic sepsis, rhabdomyolysis, hepatotoxicity, extravasation, tissue necrosis, and cardiomyopathy. Patients with known hypersensitivity to trabectedin should not take Yondelis and clinicians are also encouraged to advise women of potential risks to a developing fetus when taking Yondelis. Women who are taking Yondelis should not breastfeed.
Yondelis is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata that works by preventing the tumor cells from multiplying.
For more information call (888) 463-6332 or visit FDA.gov.