Unknown MAH — Darzalex EMA EPAR variation assessment report (EMEA/H/C/004077, 2016)
Unknown MAH · 2016 · EMA EPAR variation assessment report
Report summary
This report assesses a Type II variation for Darzalex (daratumumab) to include high-risk smouldering multiple myeloma (SMM) in adult patients. The application is supported by data from the SMM3001 (AQUILA) and SMM2001 (CENTAURUS) studies, which investigated the efficacy and safety of daratumumab in this population. Pharmacokinetic data from the SMM3001 study, specifically concerning subcutaneous daratumumab concentrations, were also included in the submission.
Key findings — cited to the page
| Orphan medicinal product designation date | 17 July 2013 | Darzalex · p.6 |
| Number of participants in PK-evaluable analysis set (SMM3001) | 193 | SMM3001 (AQUILA) · p.12 |
| Daratumumab SC dose (SMM3001) | 1800 mg | SMM3001 (AQUILA) · p.12 |
| Number of participants in PK-evaluable analysis set (SMM2001) | 122 | SMM2001 (CENTAURUS) · p.12 |
| Daratumumab IV dose (SMM2001) | 16 mg/kg | SMM2001 (CENTAURUS) · p.12 |
| Treatment-emergent anti-daratumumab antibodies | 0.5 % | SMM3001 (AQUILA) · p.15 |
| Treatment-emergent anti-rHuPH20 antibodies | 9.3 % | SMM3001 (AQUILA) · p.15 |
Source: Unknown MAH ↗ · 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 →