
Cilta-Cel in the Multiple Myeloma Treatment Landscape: Thomas G. Martin, MD
Therapy Status
Carvykti (ciltacabtagene autoleucel)
Johnson & Johnson / Legend Biotech
Approved for relapsed/refractory multiple myeloma after at least 1 prior line of therapy (lenalidomide-refractory). Boxed warnings cover CRS, ICANS, Parkinsonism/GBS, HLH/MAS, prolonged cytopenias, immune effector cell-associated enterocolitis (added October 2025), and secondary hematologic malignancies. The CAR-T REMS program was eliminated in June 2025.
- February 28, 2022 · FDA approval for r/r multiple myeloma after ≥4 prior lines
- April 19, 2024 · Class-wide boxed warning added: secondary T-cell malignancy
- June 26, 2025 · FDA eliminates REMS for approved CAR-T therapies
- October 10, 2025 · Boxed warning added: immune effector cell-associated enterocolitis Latest
The clinical professor of medicine, Helen Diller Family Comprehensive Cancer Center, UCSF, discussed data from both the CARTITUDE-1 and CARTITUDE-2 studies.
Ciltacabtagene autoleucel (cilta-cel) produced deep and durable responses in heavily-pretreated patients with multiple myeloma, according to data from the phase 1/2 CARTITUDE-1 study (NCT03548207).1,2
These data were presented at the
Also presented at ASH 2021 were results from the CARTITUDE-2 study (NCT04133636) which is evaluating cilta-cel as an earlier line of therapy in patients with only 1 to 3 prior lines of therapy.3 Progression-free survival (PFS) at 6 months was 90% (95% CI, 65.6–97.4).
GeneTherapyLive spoke with Martin to learn more about the CARTITUDE-1 and CARTITUDE-2 studies. He discussed positive safety and efficacy data seen in both studies and cilta-cel's place in the multiple myeloma treatment landscape.




















