The Food and Drug Administration has granted priority review for the use of Yondelis (trabectedin) for the treatment of patients with advanced soft tissue sarcoma, including the liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.
Yondelis, made by Janssen Research & Development, LLC, which is part of Janssen Pharmaceutical Companies of Johnson & Johnson., is a novel, multimodal, synthetically produced antitumor agent that prevents tumor cells from multiplying.
The FDA's priority review designation shortens the time to complete a drug's review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act (PDUFA).
The review for Yondelis will be based on data from the Phase III randomized, open-label ET743-SAR-3007 study, which is evaluating the safety and efficacy of the drug compared with dacarbazine for the treatment of patients with advanced liposarcoma and leiomyosarcoma in more than 500 patients previously treated with an anthracycline and ifosfamide, or an anthracycline followed by one additional line of chemotherapy. The results have not yet been presented.