Posted by Michael Wonder on 10 Jun 2026
Imugene's azer-cel granted FDA fast track designation for CLL/SLL and MZL
9 June 2026 - Imugene is pleased to announce that the US FDA has granted fast track designation to azer-cel (azercabtagene zapreleucel) for two indications: relapsed or refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma and relapsed or refractory marginal zone lymphoma.
Azer-cel is an off the shelf, CD19 directed CAR T-cell therapy engineered to overcome the logistical constraints of autologous CAR T therapies, which typically require three to six weeks to manufacture from a patient's own cells.
