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
This report summarizes Takeda's Type II variation application for Adcetris (brentuximab vedotin) to extend its indication for previously untreated advanced CD30+ Hodgkin lymphoma, in combination with BrECADD. Based on the Phase 3 HD21 study, BrECADD demonstrated superior reduction in treatment-related morbidity (TRMB) and non-inferior progression-free survival (PFS) compared to escalated BEACOPP (eBEACOPP). While BrECADD showed an improved safety profile, particularly in hematological toxicities, it had slightly higher rates of GI/hepatobiliary disorders, febrile neutropenia, and some serious adverse events. Overall survival rates were similar, but BrECADD led to fewer subsequent relapses and better quality of life. The report details efficacy, safety, and quality of life outcomes, supporting the expanded indication.
Key findings — cited to the page
| Grade 1-2 renal toxicity | 0 % | · p.70 |
| Grade 1-2 drug fever | 4 % | · p.70 |
| Grade 4 haematological toxicity | 80 % | · p.70 |
| Grade 1-2 renal toxicity | 6 % | · p.70 |
| Grade 1-2 respiratory tract toxicity | 15 % | · p.70 |
| Grade 1-2 respiratory tract toxicity | 10 % | · p.70 |
| Grade 3 hematologic events | 12 % | · p.70 |
| Grade 3 hematologic events | 10.5 % | · p.70 |
| Grade 3 infection | 13 % | · p.70 |
| Grade 3 infection | 6 % | · p.70 |
| Grade 3 hematologic events | 8 % | · p.70 |
| Grade 1-2 drug fever | 8 % | · p.70 |
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 →