# Bortezomib

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

## Approved indications

### Multiple myeloma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + dexamethasone, or with dexamethasone and thalidomide | Induction | Eligible for high-dose chemotherapy with haematopoietic stem cell transplantation |
| None | + melphalan and prednisone | 1st line | Ineligible for high-dose chemotherapy with haematopoietic stem cell transplantation |
| None | + pegylated liposomal doxorubicin or dexamethasone | 2nd line | After at least 1 prior therapy; Progressive disease; have already undergone or are unsuitable for haematopoietic stem cell transplantation |
| None | Monotherapy | 2nd line | After at least 1 prior therapy; Progressive disease; have already undergone or are unsuitable for haematopoietic stem cell transplantation |

### Mantle cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + rituximab, cyclophosphamide, doxorubicin and prednisone | 1st line | Unsuitable for haematopoietic stem cell transplantation |

## Products

### Velcade

- Company: Janssen-Cilag International NV
- Target: Proteasome inhibitor
- Class: Proteasome inhibitors
- ATC: L01XG01
- EU approval: 26 Apr 2004
- Label revised: 18 Oct 2024
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/velcade-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/velcade-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/velcade
- Biosimilars and generics: Bortezomib Accord, Bortezomib Sun, Bortezomib Fresenius Kabi

Mechanism (SmPC section 5.1): Reversibly inhibits the chymotrypsin-like activity of the 26S proteasome, disrupting protein turnover and inducing cell cycle arrest and apoptosis.

## Label wording

- **Bortezomib** (Velcade), Multiple myeloma, 2nd line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/velcade-epar-product-information_en.pdf)
- **Bortezomib** (Velcade), Multiple myeloma, 2nd line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/velcade-epar-product-information_en.pdf)
- **Bortezomib** (Velcade), Multiple myeloma, 1st line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/velcade-epar-product-information_en.pdf)
- **Bortezomib** (Velcade), Multiple myeloma, induction: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/velcade-epar-product-information_en.pdf)
- **Bortezomib** (Velcade), Mantle cell lymphoma, 1st line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/velcade-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/bortezomib