Carvykti (ciltacabtagene autoleucel) · Johnson & Johnson
Details
- Status
- Prescription
- First Approved
- 2022-02-28
- Patent Cliff
- 2034
- Revenue
- $710M (Q3-2026)
- Routes
- Intravenous
- Dosage Forms
- For Injection
Latest Carvykti News
All Carvykti news →- Nov 10, 2026 Earnings · Legend BiotechLegend Biotech Reports Third Quarter 2026 Results and Recent Highlights ↗
- Nov 4, 2026 Trials · Legend BiotechLegend Biotech to Showcase CARVYKTI® Leadership and Next-Generation Cell Therapy Innovation at ASH 2026 ↗
- Oct 13, 2026 Earnings · Legend BiotechLegend Biotech Announces Preliminary Sales for CARVYKTI® for the Quarter Ended September 30, 2026 ↗
- Single infusion of CARVYKTI® (ciltacabtagene autoleucel) delivered five-year treatment-free remissions in 50% of patients in early line relapsed/refractory multiple myeloma ↗
- Sep 10, 2026 Trials · Legend BiotechLegend Biotech to Present Updated Long-Term and Real-World Evidence from CARVYKTI Clinical Program at the International Myeloma Society Annual Meeting ↗
Carvykti Approval History
What Carvykti Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 2022)
Carvykti Target & Pathway
ProTarget
A protein highly expressed on malignant plasma cells in multiple myeloma. BCMA-targeted therapies, including CAR-T cells and bispecific antibodies, can eliminate myeloma cells while sparing most normal immune cells.
Carvykti Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Johnson & Johnson's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
Pro Intelligence Preview
Deep insights for Carvykti
Revenue Insights
- • Q3-2026: $710M
- • 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
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.