Bortezomib
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Multiple myeloma4 | |||
None | + dexamethasone, or with dexamethasone and thalidomide | Induction | Eligible for high-dose chemotherapy with haematopoietic stem cell transplantation |
None | + melphalan and prednisone | 1L | Ineligible for high-dose chemotherapy with haematopoietic stem cell transplantation |
None | + pegylated liposomal doxorubicin or dexamethasone | 2L | After at least 1 prior therapy; Progressive disease; have already undergone or are unsuitable for haematopoietic stem cell transplantation |
None | Monotherapy | 2L | After at least 1 prior therapy; Progressive disease; have already undergone or are unsuitable for haematopoietic stem cell transplantation |
| Mantle cell lymphoma1 | |||
None | + rituximab, cyclophosphamide, doxorubicin and prednisone | 1L | Unsuitable for haematopoietic stem cell transplantation |
Full text of section 4.1 (therapeutic indications)
VELCADE as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. VELCADE in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. VELCADE in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. 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.
Label history
53 changes to the Velcade label since 2004, 5 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes