Unknown MAH — Tecvayli EMA EPAR public assessment report (EMEA/H/C/005865, 2022)
Johnson & Johnson · 2022 · EMA EPAR public assessment report · company profile →
Report summary
Tecvayli (teclistamab) received a positive EMA opinion for marketing authorization on July 21, 2022, for relapsed or refractory multiple myeloma, addressing a significant unmet medical need. Granted PRIME eligibility and orphan designation, teclistamab demonstrated superior efficacy and off-the-shelf availability compared to existing therapies. Quality control, manufacturing, and non-clinical studies confirmed its binding affinity, specificity, and anti-myeloma activity. Preclinical pharmacology and toxicology data supported its mechanism and safety. The MajesTEC-1 study showed an overall response rate of 63.0% and a median duration of response of 18.4 months in heavily pre-treated patients. While cytokine release syndrome was common but manageable, long-term safety data from ongoing Phase 3 studies are awaited. Conditional marketing authorization was granted, with post-authorization measures in place.
Key findings — cited to the page
| subjects with at least 1 laboratory finding of Grade 3 or 4 thrombocytopenia, neutropenia, or lymphopenia | 154 | MajesTEC-1 (RP2D group) · p.110 |
| subjects with Grade 5 COVID-19 (out of Grade 5 infections) | 15 | MajesTEC-1 (All Treated Analysis Set) · p.111 |
| Grade 5 TEAEs in IV group | 6 | MajesTEC-1 (IV group) · p.102 |
| subjects with maximum Grade 3 peripheral neuropathy | 1 | MajesTEC-1 · p.109 |
| subjects with Grade 3 or 4 infections | 96 | MajesTEC-1 (All Treated Analysis Set) · p.111 |
| subjects with Grade 5 infections | 21 | MajesTEC-1 (All Treated Analysis Set) · p.111 |
| Grade 5 TEAEs | 18 | MajesTEC-1 (RP2D group) · p.101 |
| Grade 5 TEAEs in SC non-RP2D group | 4 | MajesTEC-1 (SC non-RP2D group) · p.102 |
| subjects with maximum Grade 1 peripheral neuropathy | 17 | MajesTEC-1 · p.109 |
| subjects with maximum Grade 2 peripheral neuropathy | 8 | MajesTEC-1 · p.109 |
| subjects with higher grade haemorrhagic TEAEs | 6 | MajesTEC-1 (RP2D group) · p.110 |
| subjects with Maximum Grade 3 or 4 infections | 60 | MajesTEC-1 (RP2D group) · p.112 |
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 →