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Imugene’s Azer-cel Gains FDA Fast Track for CLL/SLL and MZL
10:50am on Tuesday 9th of June, 2026 AEST
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Healthcare
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Imugene’s Azer-cel Gains FDA Fast Track for CLL/SLL and MZL
10:50am on Tuesday 9th of June, 2026 AEST
Key Points
FDA grants Fast Track for azer-cel in CLL/SLL and MZL
100% overall response rate in CAR T-naive CLL/SLL patients
83% response rate including four complete responses in MZL
Fast Track enables accelerated regulatory engagement and review
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