Takeda Pharmaceutical Company Limited — Adcetris EMA EPAR public assessment report (EMEA/H/C/002455, 2012)
Takeda Pharmaceutical Company Limited · 2012 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted conditional Marketing Authorisation for Adcetris (brentuximab vedotin) on July 19, 2012, for relapsed/refractory CD30+ Hodgkin lymphoma and systemic anaplastic large cell lymphoma. Preclinical studies demonstrated anti-tumor activity and characterized its pharmacokinetics and toxicology, noting myelotoxicity, hepatic, and testicular toxicity in animals. Clinical trials (SG035-0003 and SG035-0004) showed high objective response rates (55-75% in HL, 86% in sALCL). Key safety concerns include peripheral neuropathy, myelosuppression, infections, and rare but serious Progressive Multifocal Leukoencephalopathy (PML). The manufacturing process, quality control, and stability were also thoroughly assessed.
Key findings — cited to the page
| Grade 3 peripheral neuropathy | 14 % | SG035-0002 · p.47 |
| patients with grade ≥3 lymphopenia | 8 % | · p.80 |
| patients with AE grade ≥3 | 60 % | SG035-0004 · p.73 |
| patients with new or worsening platelets (Grade 3) | 6 % | phase 2 population · p.80 |
| patients with new or worsening high ALT and AST (Grade 3) | 1 % | phase 2 population · p.80 |
| patients with grade ≥3 neutropenia | 15 % | · p.80 |
| patients with worsening high glucose (≥2 grades) | 9 % | phase 2 population · p.80 |
| patients with worsening low lymphocytes (≥2 grades) | 11 % | phase 2 population · p.80 |
| patients with new or worsening low neutrophils (Grade 3) | 11 % | phase 2 population · p.80 |
| patients with new or worsening lymphocytes (Grade 3) | 11 % | phase 2 population · p.80 |
| patients with new or worsening high glucose (Grade 3) | 6 % | phase 2 population · p.80 |
| patients with new or worsening leukocytes (Grade 3) | 5 % | phase 2 population · p.80 |
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 →