Sanofi — Sarclisa EMA EPAR public assessment report (EMEA/H/C/004977, 2020)
Sanofi · 2020 · EMA EPAR public assessment report · company profile →
Report summary
This EMA report details the regulatory assessment of Sarclisa (isatuximab) for relapsed/refractory multiple myeloma. Sarclisa, an IgG1 monoclonal antibody targeting CD38, received orphan medicinal product designation. The manufacturing and quality control were deemed acceptable. Preclinical studies confirmed its mechanism, pharmacokinetics, and anti-tumor effects. Clinical trials, particularly the pivotal Phase 3 EFC14335/ICARIA study, demonstrated significantly improved progression-free survival and overall response rates when Sarclisa was combined with pomalidomide and dexamethasone (IPd) compared to Pd alone. While IPd showed a higher incidence of adverse events, the safety profile was considered manageable, with a comprehensive risk management plan in place. The report concludes with the regulatory approval of Sarclisa based on its favorable efficacy and acceptable safety profile.
Key findings — cited to the page
| Patients with any TEAE of grade >= 3 (IPd 10 mg/kg) | 86.8 % | Study EFC14335 · p.94 |
| Patients with any TEAE of grade >= 3 (Pd) | 70.5 % | Study EFC14335 · p.94 |
| AESI-Thrombocytopaenia Grade ≥3 (all isatuximab treated patients) | 23.0 % | All isatuximab treated patients · p.122 |
| Patients with any TEAE (any grade) (IPd 10 mg/kg) | 99.3 % | Study EFC14335 · p.94 |
| Patients with any treatment-related TEAE (any grade) (Pd) | 79.9 % | Study EFC14335 · p.94 |
| Patients with any treatment-related TEAE (any grade) (IPd 10 mg/kg) | 90.8 % | Study EFC14335 · p.94 |
| AESI-IRR Overall (all isatuximab treated patients) | 46.2 % | All isatuximab treated patients · p.122 |
| AESI-IRR Grade ≥3 (all isatuximab treated patients) | 3.5 % | All isatuximab treated patients · p.122 |
| AESI-Thrombocytopaenia Grade ≥3 (haemorrhage) | 24.5 % | Pd · p.122 |
| Patients with any TEAE (any grade) (Pd) | 98.0 % | Study EFC14335 · p.94 |
| AESI-Thrombocytopaenia Grade ≥3 (haemorrhage) | 30.9 % | Sarclisa + Pd · p.122 |
| Neutropenia (IPd, all grades) | 46.7 % | Study EFC14335 · p.95 |
Source: Sanofi ↗ · 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 →