Carvykti(cilta-cel)
Oncology· 1131 cited findings· 2 source documents
Company: Johnson & Johnson →
What the regulatory reviews say
Carvykti (cilta-cel) is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy. It received Orphan medicinal product designation on 28 February 2020 and PRIME eligibility on 28 March 2019. An Accelerated Assessment procedure was agreed upon on 28 January 2021, leading to a CHMP positive opinion on 24 March 2022.
In clinical trials, Carvykti demonstrated an Overall Response Rate (ORR) of 87.8%, with a Complete Response (CR) rate of 64%. The Estimated duration of response was 14.32 months, and the Progression-Free Survival (PFS) was 14.85 months. The 12-month Progression-Free Survival (PFS) rate in the All Treated population was 76.6%. The median time to first response was 0.95 months, and the median time to best response was 2.6 months.
Regarding safety, 15.5% of subjects were positive for treatment-emergent anti-cilta-cel antibodies (ADA). The median duration of ICANS was 4 days. Regulatory commitments include due dates for final study results of CARTITUDE-1 (MMY2001) in December 2022 and CARTITUDE-4 (MMY3002) in December 2026, with observational post-authorisation safety study results due in December 2042.
Key figures — cited to the source page
| Overall Response Rate (ORR) | 87.8% | Johnson & Johnson — Carvykti EMA EPAR public assessment repo, p.7 |
| Complete Response (CR) rate | 64% | Johnson & Johnson — Carvykti EMA EPAR public assessment repo, p.7 |
| Estimated duration of response | 14.32 months | Johnson & Johnson — Carvykti EMA EPAR public assessment repo, p.7 |
| Progression-Free Survival (PFS) | 14.85 months | Johnson & Johnson — Carvykti EMA EPAR public assessment repo, p.7 |
| 12-month Progression-Free Survival (PFS) rate (All Treated population) | 76.6% | Johnson & Johnson — Carvykti EMA EPAR public assessment repo, p.80 |
| percentage of subjects positive for treatment-emergent anti-cilta-cel antibodies (ADA) | 15.5 % | Johnson & Johnson — Carvykti EMA EPAR public assessment repo, p.46 |
| Median duration of ICANS | 4 days | Johnson & Johnson — Carvykti EMA EPAR public assessment repo, p.107 |
| CHMP positive opinion date | 24 March 2022 | Johnson & Johnson — Carvykti EMA EPAR public assessment repo, p.11 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.