Bortezomib

Bortezomib (Velcade, Janssen-Cilag International NV) has 5 EU-approved indications in 2 tumour types.
Approved indications of Bortezomib
Biomarker requirementRegimenSettingConditions
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