Anito-cel (anitocabtagene autoleucel) by Kite Pharma (Gilead): status and timeline

Milestones

Next · FDA PDUFA decision

Phase 1: 100% overall response rate2024Complete.
Phase 2 iMMagine-1: 97% ORR2025Complete.
BLA accepted by FDA23 Feb 2026Complete.
FDA PDUFA decisionTarget 23 Dec 2026Not yet reached.

Most important updates

Gilead to acquire Arcellx for $7.8B23 Feb 2026
Phase 2 iMMagine-1: 97% response for Anito-cel14 May 2025

Upcoming

23 Dec 2026FDA PDUFA decisionin 73 days (next)

Current obstacles

Manufacturing complexityPatient-specific production requires weeks; cost and access limits.

Physics limits

Antigen escapeCancer cells can lose BCMA, leading to relapse.

How it works

3 parts

D-Domain binder

Compact BCMA targeting

Compact D-Domain targets BCMA on myeloma cells with high expression.

CAR-T infusion

One-time cell therapy

Single infusion of engineered T cells circulates to find and destroy myeloma.

Safety

Manageable toxicity

Predictable safety profile with no delayed neurotoxicity observed.

Spec sheet

Spec	Anito-cel (anitocabtagene autoleucel)
Phase 2 ORR	97%^R (reported)
Phase 2 CR/sCR	68%^R (reported)

^R reported by the company

Update log

2 updates

Mon 23 Feb

Major: Gilead to acquire Arcellx for $7.8BPressCommercial

Wed 14 May 2025

Major: Phase 2 iMMagine-1: 97% response for Anito-celPressTest

About Kite Pharma (Gilead)

The team behind Anito-cel (anitocabtagene autoleucel)

Kite Pharma (Gilead)

CAR-T cell therapy, BCMA, multiple myeloma

Gilead's cell therapy arm. Gilead bought Arcellx, the original developer of anito-cel, for about $7.8B in April 2026, so Kite now develops this BCMA CAR-T for multiple myeloma on its own.

Gilead closed its Arcellx purchase on 28 April 2026: $115 a share in cash plus a $5 right paid if sales pass $6B by 2029.
Owning anito-cel outright ends the profit share, milestone and royalty payments to Arcellx.

Company profile →

Headquarters: United States
Status: Subsidiaryof Gilead Sciences
Valuation: Gilead Sciences-owned
Works in: BiotechCell & organ therapies
Coverage: 1 program · 2 updateslatest 23 Feb 2026checked 11 Oct