Data updated: May 26, 2026
Abecma (idecabtagene vicleucel)
Approved 2021-03-02
1
Indication
--
Phase 3 Trials
5
Years on Market
Details
- Status
- Prescription
- First Approved
- 2021-03-02
- Patent Cliff
- 2033
- Revenue
- $130M (Q4-2025)
- Routes
- Intravenous
- Dosage Forms
- Suspension
Companies
Website: ↗
Abecma Approval History
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2021 to 2021
Mar 2021 ORIGINAL
Update · CBER biologic (Purple Book)
What Abecma Treats
1 FDA approvalsOriginally approved for its first indication in 2021 .
- Other (1)
Other
(1 approval)- • Approved indication (Mar 2021)
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06045806 KarMMa-9 | CA089-1043 2022-501346-30, U1111-1280-9736 | Ph 3 | active not recruiting | A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation |
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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.
Abecma FDA Label Details
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Revenue Insights
- • Q4-2025: $130M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 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.