Velcade

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Questions and answers

On 2 July 2012, Janssen-Cilag International N.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation of Velcade, which would have extended its use to patients with relapsed follicular non-Hodgkin lymphoma.

What is Velcade?

Velcade is a medicine given by injection that contains the active substance bortezomib. It has been authorised in the European Union (EU) since April 2004. It is used to treat patients with multiple myeloma (a cancer of the plasma cells in the bone marrow). It is given in combination with melphalan and prednisone (other medicines for multiple myeloma) to patients who have not been treated before and who are not suitable for high-dose chemotherapy with a bone marrow transplant. It is also used on its own in patients whose disease is progressive and who have failed to respond to at least one other treatment and have already had, or cannot undergo, a bone marrow transplant.

What was Velcade expected to be used for?

Velcade was also expected to be used in follicular non-Hodgkin lymphoma (a cancer of the lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes, or B cells), in combination with another medicine called rituximab in patients whose disease had relapsed (returned after treatment).

How was Velcade expected to work?

In relapsed follicular non-Hodgkin lymphoma, Velcade was expected to work in the same way as it does in its existing indications. The active substance in Velcade, bortezomib, is a proteasome inhibitor.

It blocks the proteasome, which is a system within cells that breaks down proteins when they are no longer needed. When the proteins in cancer cells, such as the proteins that control the growth of the cells, are not broken down, the cells are affected and eventually die.

What did the company present to support its application?

The applicant presented the results of a study involving 676 patients with follicular non-Hodgkin lymphoma that had relapsed or progressed despite previous treatments, designed to assess the effects of using Velcade in combination with rituximab compared with using rituximab alone in these patients. The main measure of effectiveness was progression-free survival (how long the patients lived without their disease getting worse).

How far into the evaluation was the application when it was withdrawn?

The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions. After the CHMP had assessed the company’s responses to its first round of questions, there were still some unresolved issues.

What was the recommendation of the CHMP at that time?

Based on the review of the data and the company’s response to the CHMP’s questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Velcade could not have been approved for the treatment of patients with relapsed follicular non-Hodgkin lymphoma.

The CHMP questioned the relevance of the study results which showed that, overall, patients treated with Velcade plus rituximab lived without their disease getting worse for an average of 1.8 months longer than patients treated with rituximab alone (12.8 months compared with 11 months). The Committee considered that this difference was unlikely to be relevant and was not convinced that a sub-group of patients had been identified who would benefit more from the addition of Velcade to rituximab. The CHMP had concerns about the methodology used to analyse the results, which left some uncertainties about the size of the effect seen. The CHMP was also concerned that the combination of Velcade and rituximab caused more side effects than rituximab alone.

Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Velcade in the treatment of relapsed follicular non-Hodgkin lymphoma did not outweigh its risks.

What were the reasons given by the company for withdrawing the application?

In its official letter, the company stated that it decided to withdraw the application because the CHMP considered that the data provided did not support a positive benefit-risk balance.

The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents’.

What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?

The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Velcade. If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.

What is happening with Velcade for the treatment of multiple myeloma?

There are no consequences on the use of Velcade in its authorised indications.

Name Language First published Last updated
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) BG = bălgarski 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) ES = español 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) CS = čeština 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) DA = dansk 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) DE = Deutsch 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) ET = eesti keel 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) EL = elliniká 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) EN = English 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) FR = français 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) IT = italiano 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) LV = latviešu valoda 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) LT = lietuvių kalba 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) HU = magyar 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) MT = Malti 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) NL = Nederlands 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) PL = polski 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) PT = português 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) RO = română 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) SK = slovenčina 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) SL = slovenščina 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) FI = suomi 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) SV = svenska 2012-07-31  

Press release

Janssen-Cilag International NV withdraws its application for an extension of the indication for Velcade (bortezomib)

The European Medicines Agency has been formally notified by Janssen-Cilag International NV of its decision to withdraw its application for an extension of the therapeutic indication for the centrally authorised medicine Velcade (bortezomib).

On 2 September 2011, Janssen-Cilag International NV submitted an application to extend the marketing authorisation for Velcade in combination with rituximab for the treatment of patients with relapsed follicular non-Hodgkin's lymphoma. At the time of the withdrawal the application was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).

Velcade was first authorised in the European Union on 26 April 2004 and is indicated in combination with melphalan and prednisone to treat patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with a bone-marrow transplant. Velcade is also indicated as monotherapy to treat progressive multiple myeloma in patients who have received at least one prior therapy and have already had or are unsuitable for a bone-marrow transplant.

In its official letter, the company stated that it decided to withdraw the application after the CHMP indicated that the data provided do not support a positive benefit-risk balance.

Velcade continues to be authorised in the currently approved indications.

More information about Velcade and the state of the scientific assessment at the time of the withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the Agency's website after the 16-19 July 2012 CHMP meeting.

Note

  • Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.

Key facts

Product details for Velcade
NameVelcade
Product numberEMEA/H/C/000539
Date of issue of marketing authorisation valid throughout the European Union (if applicable)26/04/2004
International non-proprietary name or common name

bortezomib

Active substancebortezomib
Date of withdrawal02/07/2012
Company making the application

Janssen-Cilag International NV

Withdrawal typePost-authorisation

All documents

Name Language First published Last updated
Withdrawal assessment report for Velcade (English only) 2012-08-30  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) BG = bălgarski 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) ES = español 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) CS = čeština 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) DA = dansk 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) DE = Deutsch 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) ET = eesti keel 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) EL = elliniká 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) EN = English 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) FR = français 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) IT = italiano 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) LV = latviešu valoda 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) LT = lietuvių kalba 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) HU = magyar 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) MT = Malti 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) NL = Nederlands 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) PL = polski 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) PT = português 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) RO = română 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) SK = slovenčina 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) SL = slovenščina 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) FI = suomi 2012-07-31  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Velcade (bortezomib) SV = svenska 2012-07-31  
Withdrawal letter: Velcade (bortezomib) (English only) 2012-07-31  
Janssen-Cilag International NV withdraws its application for an extension of the indication for Velcade (bortezomib) (English only) 2012-07-03  

News

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').