Takeda Pharmaceutical Company Limited — Adcetris EMA EPAR variation assessment report (EMEA/H/C/002455, 2012)
Takeda Pharmaceutical Company Limited · 2012 · EMA EPAR variation assessment report · company profile →
Report summary
Takeda Pharma A/S sought a Type II variation for Adcetris (brentuximab vedotin) to expand its indication for adult patients with previously untreated CD30+ advanced Hodgkin lymphoma (HL), specifically Stage III, in combination with AVD. This application was supported by the second interim analysis of overall survival data from the ECHELON-1 study. This Phase 3, randomized, open-label trial compared A+AVD against ABVD as a frontline treatment for advanced classical HL.
Key findings — cited to the page
| Dose of dacarbazine (A+AVD arm) | 375 mg/m2 | ECHELON-1 (C25003) · p.14 |
| Type II variation application submission date | 8 March 2023 | Adcetris · p.5 |
| Orphan medicinal product designation date | 15 Jan 2009 | Adcetris · p.5 |
| First marketing authorization for brentuximab vedotin in EU | October 2012 | brentuximab vedotin · EU · p.10 |
| Trial phase | Phase 3 | ECHELON-1 (C25003) · p.13 |
| Randomization ratio | 1:1 | ECHELON-1 (C25003) · p.14 |
| Dose of doxorubicin (A+AVD arm) | 25 mg/m2 | ECHELON-1 (C25003) · p.14 |
| Dose of vinblastine (A+AVD arm) | 6 mg/m2 | ECHELON-1 (C25003) · p.14 |
| Dose of brentuximab vedotin (A+AVD arm) | 1.2 mg/kg | ECHELON-1 (C25003) · p.14 |
| Dose of doxorubicin (ABVD arm) | 25 mg/m2 | ECHELON-1 (C25003) · p.14 |
| Dose of bleomycin (ABVD arm) | 10 units/m2 | ECHELON-1 (C25003) · p.14 |
| Dose of vinblastine (ABVD arm) | 6 mg/m2 | ECHELON-1 (C25003) · p.14 |
Source: Takeda Pharmaceutical Company Limited ↗ · 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 →