Anitocabtagene Autoleucel

Drug

Also known as: anito-cel, anitocel

Drug Profile

Anitocabtagene autoleucel (anito-cel) is an investigational BCMA-directed CAR T-cell therapy for multiple myeloma developed by Kite and Arcellx. It has shown deep and durable responses in clinical studies and has entered late-stage regulatory review in the U.S. for relapsed/refractory disease. The program remains pre-approval pending FDA action.

Drug Class
BCMA-directed autologous CAR T-cell therapy
Approval Status
Investigational; FDA accepted BLA with PDUFA target date of December 23, 2026
Mechanism of Action
Engineered CAR T-cell therapy targeting BCMA, using a D-domain binder construct
Indications
  • \Relapsed or refractory multiple myeloma\

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Gilead Sciences reported Q1 2026 total product sales of $6.9 billion, up 5% year over year, with HIV revenue growing 10% to $5.0 billion. The company raised its full-year 2026 base business revenue guidance by $400 million to $29.4–$29.8 billion. Non-GAAP diluted EPS was $2.03, up 12%, while the company advanced its oncology and cell therapy pipeline.

Related Clinical Trials

NCT ID Title Status Phase
NCT07045909

Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST)

RECRUITING PHASE2
NCT06413498

A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma

RECRUITING PHASE3