The FDA has issued an approval to the biologics license application (BLA) for the CD19-directed chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (Breyanzi; liso-cel) in the treatment of adult patients with certain types of large B-cell lymphoma following 2 or more prior therapies.1
Liso-cel targets CD19 expression through a CAR construct comprised of a 4-1BB costimulatory domain for T-cell propagation and preservation, and a CD3-z T-cell activation domain, and an anti-CD19 single-chain variable fragment–targeting domain for antigen specificity.
“Today’s approval represents another milestone in the rapidly progressing field of gene therapy by providing an additional treatment option for adults with certain types of cancer affecting the blood, bone marrow, and lymph nodes,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation…
