Janssen Research & Development, LLC, is seeking FDA approval for trabectedin in patients with advanced soft tissue sarcoma, including those with liposarcoma and leimyosarcoma who have already underwent chemotherapy involving an anthracycline.
Janssen Research & Development, LLC, is seeking FDA approval for trabectedin (Yondelis) in patients with advanced soft tissue sarcoma (STS), including those with liposarcoma and leimyosarcoma who have already underwent chemotherapy involving an anthracycline.
The manufacturer has submitted a new drug application to the FDA for Yondelis, which aims to prevent tumor cells from multiplying.
Janssen is currently studying the safety and efficacy of Yondelis compared with dacarbazine in 500 patients previously treated with an anthracycline and ifosfamide or an anthracycline followed by 1 additional line of chemotherapy, according to a press release.
The company said it would revise protocol for its phase 3 study, on which its regulatory submission is based, so that those randomized to receive dacarbazine have the option of also receiving Yondelis at their physician’s discretion.
Results of that trial have not been released yet.
"Today, we are one step closer to our goal of making another treatment option available for people living with advanced soft tissue sarcoma," said Denise Reinke, president and CEO of Sarcoma Alliance for Research through Collaboration, in a press release. "People living with this type of cancer are in urgent need of new options to help treat their disease, and we welcome new medicines that may help make a difference in their lives."