On June 9, 2026 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported 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).

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The FDA’s Fast Track Designation is designed to facilitate the development and expedite the review of drugs that treat serious or life-threatening conditions and meet an unmet medical need. Benefits include more frequent meetings with the FDA to discuss development plans, the option for rolling review of regulatory submissions, and potential eligibility for Accelerated Approval and Priority Review upon meeting the relevant criteria.

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. By using pre-manufactured donor T-cells, azer-cel can be ready to administer within days. For patients with relapsed or refractory disease who have exhausted standard treatment options, that speed is clinically significant.

Chronic Lymphocytic Leukaemia / Small Lymphocytic Lymphoma (CLL/SLL)

CLL/SLL is one of the most common blood cancers in adults. Many patients experience disease progression despite multiple prior treatments. Clinical data from the Phase 1b basket study demonstrates a 100% ORR in the CAR T-naive CLL/SLL cohort, in patients who had received a median of three or more prior lines of therapy. Azer-cel’s activity in CAR T-naive patients is significant in demonstrating the potential of an off-the-shelf allogeneic approach to deliver responses in patients who have not previously received cellular therapy.

Marginal Zone Lymphoma (MZL)

MZL is an indolent but incurable B-cell lymphoma. Patients who relapse following standard therapies including anti-CD20 chemoimmunotherapy have limited remaining options. Updated clinical data from the Phase 1b basket study, which post-dates the ASCO (Free ASCO Whitepaper) data cut, shows an 83% ORR in MZL, based on five of six evaluable patients responding, including four complete responses, in patients who had received a median of two or more prior lines of therapy.

Leslie Chong, Managing Director and CEO of Imugene, commented: "FDA Fast Track Designation for both CLL/SLL and MZL reflects the meaningful clinical activity we are seeing with azer-cel across multiple B-cell malignancies. For patients who have exhausted standard treatment options in these indications, we believe azer-cel represents a genuinely promising approach, and this designation will support closer engagement with the FDA as we advance the program."

(Press release, Imugene, JUN 9, 2026, View Source [SID1234666511])