CTI to Submit sBLA for Zevalin
Cell Therapeutics Inc. (CTI) plans to file a supplemental biologics license application (sBLA) using the results of the Phase III FIT trial of Zevalin.
Zevalin (ibritumomab tiuxetan) is a potential treatment for first remissions following chemotherapy for patients with follicular non-Hodgkin’s lymphoma.
CTI signed an agreement with Biogen Idec to acquire the U.S. marketing, sales and development rights to Zevalin; however, the acquisition has not been completed and remains subject to closing conditions, CTI said.
Bayer Schering has submitted the FIT results to the European Medicines Agency for consideration for a new indication in the European Union.