
Binod Dhakal, MD, on Assessing Cilta-Cel in Lenalidomide-Refractory Multiple Myeloma
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 associate professor at Medical College of Wisconsin discussed the rationale for the CARTITUDE-4 study and its latest updates.
“In the current practice pattern, there is widespread use of lenalidomide as early as after frontline treatment. And if you look at the real-world data, about 10% of patients are lenalidomide-refractory. And if you look at the clinical trials setting, almost 70% of the patients who are exposed to lenalidomide become refractory. Now based on a study that we performed, we found that this patient population doesn’t do that well, including patients treated with newer therapies.”
Patients with relapsed multiple myeloma after lenalidomide had higher rates of progression-free survival (PFS) after treatment with ciltacabtagene ciloleucel (cilta-cel; Carvykti; Janssen) chimeric antigen receptor (CAR) T-cell therapy compared with standard of care (SOC) therapies, as seen in updated data from the phase 3 CARTITUDE-4 study (NCT04181827).
These data were presented at
REFERENCE
Dhakal B, Yong K, Harrison SJ, et al. First phase 3 results from CARTITUDE-4: Cilta-cel versus standard of care (PVd or DPd) in lenalidomide-refractory multiple myeloma. Presented at: ASCO 2023 Annual Meeting; June 2-6; Chicago, Illinois. Abstract #LBA106















