13 February 2020 - Application based on results from the TRANSCEND NHL 001 trial, the largest study of CD19-directed CAR T cells to support a BLA to date.
Bristol-Myers Squibb today announced that the U.S. FDA has accepted for priority review its biologics license application for lisocabtagene maraleucel (liso-cel), the company’s autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after at least two prior therapies.
The FDA has set a Prescription Drug User Fee Act goal date of 17 August 2020.