Anitocabtagene autoleucel
Anitocabtagene autoleucel is a BCMA CAR-T with a novel small synthetic binder that produced responses in 97% of heavily pretreated patients; an FDA decision is due in December 2026.
iMMagine-1 (phase 2, ≥4 prior lines): ORR 97%, high MRD negativity, no delayed parkinsonism reported to date. BLA accepted February 2026; PDUFA 27 December 2026. Gilead/Kite acquired Arcellx (closed April 2026). iMMagine-3 (phase 3, second line and beyond) and iMMagine-4 (newly diagnosed) follow.
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- Feb 2026Filing / dealUS
BLA accepted; PDUFA 27 December 2026 source
Trials
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Landmark trials in OnCo
Latest papers
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