Johnson & Johnson — Velcade EMA EPAR variation assessment report (EMEA/H/C/000539, 2004)
Johnson & Johnson · 2004 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of a Type II variation for Velcade (bortezomib) to update its Summary of Product Characteristics with pediatric data from study AALL07P1. This single-arm Phase 2 study investigated Velcade plus chemotherapy in children and young adults with relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL). While BSA-scaled dosing was deemed appropriate, efficacy results were mixed and difficult to interpret due to the lack of direct comparison and some pre-specified thresholds not being met. Safety analysis revealed increased adverse events with Velcade-containing regimens. Despite inconclusive efficacy data for this specific pediatric indication, the overall benefit-risk balance for Velcade's approved adult indications remains positive, and updates to the product information are endorsed.
Key findings — cited to the page
| Grade ≥ 3 hypokalaemia incidence | 18% | · p.41 |
| Patients with grade >= 3 TEAE | 81% | AALL07P1 · p.6 |
| Grade ≥ 3 hypoxia incidence | 8% | · p.41 |
| Grade ≥ 3 increased ALT incidence | 17% | · p.41 |
| Grade ≥ 3 hyponatraemia incidence | 12% | · p.41 |
| Grade ≥ 3 hyponatraemia incidence | 4% | · p.41 |
| Grade ≥ 3 peripheral sensory neuropathy incidence | 3% | · p.41 |
| Grade ≥ 3 ileus incidence | 2.1% | · p.41 |
| Grade ≥ 3 infections with neutropenia incidence | 24% | · p.41 |
| Grade ≥ 3 infections with neutropenia incidence | 22% | · p.41 |
| Grade ≥ 3 hypokalaemia incidence | 21% | · p.41 |
| Grade >= 3 ileus (AALL07P1) | 2.1% | AALL07P1 · p.7 |
Source: Johnson & Johnson ↗ · 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 →