Johnson & Johnson — Carvykti EMA EPAR public assessment report (EMEA/H/C/005095, 2022)
Johnson & Johnson · 2022 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted conditional marketing authorization for Carvykti (ciltacabtagene autoleucel) for relapsed/refractory multiple myeloma, recognizing its orphan designation and PRIME eligibility. This CAR-T therapy targets BCMA, addressing an unmet medical need despite existing treatments. Manufacturing, quality control, and non-clinical studies confirmed its BCMA-specific activation. The pivotal CARTITUDE-1 (MMY2001) study, a single-arm Phase 1b/2 trial, demonstrated a 97.9% overall response rate and 21.8-month median duration of response. Safety concerns include high rates of cytopenias, cytokine release syndrome (CRS), and neurotoxicity, with 6.2% of deaths drug-related. Post-authorization studies and a controlled distribution program are mandated to manage risks and gather long-term efficacy and safety data, including final results from CARTITUDE-1 and CARTITUDE-4.
Key findings — cited to the page
| Grade 5 CRS | 1 subject | · p.107 |
| Grade 5 Other Neurotoxicity | 1.0 % | · p.108 |
| Grade 3 or 4 thrombocytopenia | 79.4% | MMY2001 · p.106 |
| Grade 3 or 4 CRS | 94.8% | MMY2001 · p.106 |
| Grade 3 or 4 Other Neurotoxicity | 8.2 % | · p.108 |
| Grade 5 Other Neurotoxicity | 1 subject | · p.108 |
| Grade 3 or 4 neutropenia | 95.9% | MMY2001 · p.106 |
| Grade 3 or 4 anaemia | 81.4% | MMY2001 · p.106 |
| Grade 3 or 4 leukopenia | 61.9% | MMY2001 · p.106 |
| Grade 3 or 4 lymphopenia | 52.6% | MMY2001 · p.106 |
| Grade 3 or 4 Other Neurotoxicity | 8 subjects | · p.108 |
| Infections (all grades) | 56 subjects | · p.109 |
Source: Johnson & Johnson ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →