December 21, 2020 -- Cell therapies firm Legend Biotech has begun a rolling submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for a chimeric antigen receptor (CAR) T-cell therapy for adults with myeloma.
The therapy is an investigational B-cell maturation antigen (BCMA)-directed CAR T-cell treatment designed for adults with relapsed and/or refractory multiple myeloma. The BLA was submitted based on promising results from a phase IB/II trial evaluating the therapy's safety and efficacy in patients.
Legend's collaborative partner, Janssen Biotech, submitted the BLA to the FDA, noted Legend. In 2017, Janssen and Legend entered into a global license and collaboration agreement to develop and commercialize cilta-cel.
Under terms of its existing agreement, Legend has achieved a $75 million milestone payment related to the clinical development of cilta-cel and submission of the BLA. The firm will also continue to study the efficacy cilta-cel in the ongoing phase II portion of the open-label, multicenter clinical trial.