Data updated: May 26, 2026
Carvykti (ciltacabtagene autoleucel)
Approved 2022-02-27
1
Indication
--
Phase 3 Trials
4
Years on Market
Details
- Status
- Prescription
- First Approved
- 2022-02-27
- Patent Cliff
- 2034
- Revenue
- $580M (Q4-2025)
- Routes
- Intravenous
- Dosage Forms
- For Injection
Carvykti Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2022 to 2022
Feb 2022 ORIGINAL
Update · CBER biologic (Purple Book)
What Carvykti Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 2022)
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Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05767359 | 22-546 | Ph 2 | active not recruiting | CAR- PRISM (PRecision Intervention Smoldering Myeloma) |
| NCT06623630 | 202410010 | Ph 1 | recruiting | Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function |
| NCT06940297 | MC240801 NCI-2025-02490, 24-002915 | Ph 2 | recruiting | Dasatinib and Quercetin With CAR-T Therapy for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma |
| NCT07093554 | PRO00055520 | Ph 1 | recruiting | Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Carvykti FDA Label Details
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Deep insights for Carvykti
Revenue Insights
- • Q4-2025: $580M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.