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 details a Type II variation application for Velcade (bortezomib) by Janssen-Cilag International N.V., aiming to extend its indication for previously untreated mantle cell lymphoma (MCL). The proposed new indication is for Velcade in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP). The application includes non-clinical and clinical data, with a primary focus on the LYM-3002 study. This study compared the efficacy and safety of VcR-CAP against R-CHOP in patients with MCL who were not eligible for stem cell transplantation.
Key findings — cited to the page
| Grade 3 and 4 thrombocytopenia (biweekly Velcade + R-CHOP) | 14 % of cycles | · p.11 |
| R-CHOP Vincristine dose | 1.4 mg/m2 | · p.13 |
| 5-year survival for low-risk MCL | 60 % | · p.7 |
| Submission date | 12 June 2014 | VELCADE · p.7 |
| Opinion date | 18 December 2014 | · p.7 |
| Procedure Number | EMEA/H/C/000539/II/0072 | VELCADE · p.1 |
| Application Type | Type II variation | VELCADE · p.6 |
| median OS for intermediate-risk MCL | 51 months | · p.7 |
| median OS for high-risk MCL | 29 months | · p.7 |
| Approved indication for Velcade | Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation. | VELCADE · p.8 |
| Velcade dose | 1.3 mg/m2 | VELCADE · p.8 |
| R-CHOP Prednisone dose | 100 mg/m2 | · p.13 |
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 →