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 details a Type II variation for Adcetris (brentuximab vedotin) to update its SmPC based on final results from Study C25006, a Phase 4 study in relapsed/refractory systemic anaplastic large-cell lymphoma (sALCL). The study confirmed the drug's positive benefit-risk profile, leading to the conversion of its conditional marketing authorization to a full marketing authorization. The pharmacokinetics and immunogenicity were consistent with previous findings, and the anti-tumor activity remained high with an overall response rate (ORR) of >60%.
Key findings — cited to the page
| Procedure No. | EMEA/H/C/002455/II/0099 | ADCETRIS · p.1 |
| Marketing authorization status | full marketing authorisation not subject to specific obligations | brentuximab vedotin · p.5 |
| Application for variation submission date | 21 December 2021 | · p.4 |
| Start of procedure | 24 Jan 2022 | · p.2 |
| Opinion date | 24 Mar 2022 | · p.2 |
| Study C25006 ALK+ ALCL patients | 14 patients | Study C25006 · p.15 |
| Study C25006 ALK- ALCL patients | 36 patients | Study C25006 · p.15 |
| Study C25006 phase | Phase 4 | Study C25006 · p.4 |
| Study C25006 enrolment N | 50 patients | Study C25006 · p.4 |
| Study C25006 patients aged <=65 years | 33 patients | Study C25006 · p.15 |
| Study C25006 patients aged >=65 years | 17 patients | Study C25006 · p.15 |
| Study C25006 design | single-arm, open-label, multi-centre Phase 4 clinical study | Study C25006 · p.9 |
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 →