IMU.ASX: Azer-cel Granted FDA Fast Track Designation for CLL and MZL

Azer-cel Granted FDA Fast Track Designation for CLL and MZL

Stock	Imugene Ltd (IMU.ASX)
Release Time	9 Jun 2026, 10:50 a.m.
Price Sensitive	Yes

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FDA Fast Track Designation for Azer-cel in CLL/SLL and MZL

Key Points

Fast Track Designation for azer-cel in CLL/SLL and MZL
Facilitates expedited development and review
Phase 1b data shows 100% ORR in CLL/SLL and 83% ORR in MZL

Full Summary

Imugene Limited (ASX:IMU) announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to azer-cel (azercabtagene zapreleucel) for two indications: relapsed or refractory Chronic Lymphocytic Leukaemia / Small Lymphocytic Lymphoma (CLL/SLL) and relapsed or refractory Marginal Zone Lymphoma (MZL). This designation is intended to expedite the development and review of drugs addressing serious conditions with unmet medical needs. Azer-cel, an off-the-shelf, CD19-directed CAR T-cell therapy, aims to overcome the logistical constraints of autologous CAR T therapies. Clinical data from the Phase 1b basket study demonstrated a 100% overall response rate (ORR) in the CAR T-naive CLL/SLL cohort and an 83% ORR in MZL, including four complete responses.