Johnson & Johnson — Carvykti EMA EPAR variation assessment report (EMEA/H/C/005095, 2022)
Johnson & Johnson · 2022 · EMA EPAR variation assessment report · company profile →
Report summary
This report details a Type II variation application for CARVYKTI (Ciltacabtagene autoleucel) to extend its indication for relapsed and refractory multiple myeloma, based on interim results from the Phase 3 MMY3002 (CARTITUDE-4) study. Cilta-cel demonstrated significantly superior efficacy compared to standard therapies (PVd/DPd), showing improved progression-free survival, overall response rates, complete response rates, and MRD negativity. While overall survival data are maturing, initial trends are favorable. Safety analysis identified cytokine release syndrome (CRS), neurotoxicity (including ICANS), and hematologic toxicities as common adverse events. Despite these, the overall benefit-risk profile for cilta-cel is considered positive, supporting the requested indication extension and a 1-year market protection extension.
Key findings — cited to the page
| Grade 2 cranial nerve palsy | 14 participants | · p.117 |
| Grade 3 peripheral neuropathy | 1 participant | · p.117 |
| Grade 2 ICANS | 2 participants | · p.117 |
| Grade 3 or 4 CAR T cell neurotoxicity incidence | 2.8 % | cilta-cel (Study MMY3002) · p.33 |
| Grade 1 peripheral neuropathy | 6 participants | · p.117 |
| Grade 2 peripheral neuropathy | 6 participants | · p.117 |
| Grade 1 CRS incidence | 52.8 % | cilta-cel (Study MMY3002) · p.33 |
| Grade 1 ICANS | 6 participants | · p.117 |
| Grade 2 CRS incidence | 22.2 % | cilta-cel (Study MMY3002) · p.33 |
| Grade 3 CRS incidence | 1.1 % | cilta-cel (Study MMY3002) · p.33 |
| Grade 3 cranial nerve palsy | 2 participants | · p.117 |
| Incidence of Hypogammaglobulinaemia (Grade 3-4) | 8.5 % | Study MMY3002 · p.102 |
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 →