Erbitux

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Questions and answers

On 17 September 2012, Merck KGaA 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 for Erbitux, to extend its use in the treatment of non-small-cell lung cancer.

What is Erbitux?

Erbitux is an anticancer medicine which has been authorised in the European Union (EU) since 29 June 2004. It is used to treat adults with colorectal cancer (a cancer of the large intestine) when the cancer is metastatic (has spread to other parts of the body). Erbitux is used in patients whose tumour cells have a protein on their surface called epidermal growth factor receptor (EGFR) and contain a ‘wild-type’ (non-mutated) gene called ‘KRAS’. In colorectal cancer it can be used in combination with chemotherapy (medicines to treat cancer) or on its own.

Erbitux is also used to treat squamous-cell cancers of the head and neck. In locally advanced cancer (when the tumour has grown but has not spread), Erbitux is given in combination with radiotherapy (treatment with radiation). In cancer that is recurrent (has come back after previous treatment) or metastatic, Erbitux is used with a ‘platinum-based’ anticancer medicine combination.

What was Erbitux expected to be used for?

Erbitux was also expected to be used to treat advanced or metastatic non-small-cell lung cancer, when the tumour cells have high levels of EGFR on their surface. It was to be used in combination with platinum-based chemotherapy in patients who had not been treated before.

How is Erbitux expected to work?

In non-small-cell lung cancer, Erbitux was expected to work in the same way as it does in its existing indications. The active substance in Erbitux, cetuximab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to EGFR, which can be found on the surface of some tumour cells. When it attaches to EGFR, the tumour cells can no longer receive the messages needed for growth, progression and spread.

What did the company present to support its application?

The applicant presented a re-analysis of the data from one main study involving 1,125 patients with advanced or metastatic non-small-cell lung cancer with EGFR. The study had been previously used to support an application for the use of Erbitux in non-small-cell lung cancers, but this application had been refused. In the study, patients were given cisplatin and vinorelbine (two chemotherapy medicines) with or without Erbitux. The main measure of effectiveness was overall survival (the length of time the patients lived). The company presented an analysis of the study data, comparing the survival of patients whose tumour cells had high levels of EGFR on their surface, with the survival of patients whose tumours had low levels of EGFR.

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 the 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 questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Erbitux could not have been approved for the treatment of non-small-cell lung cancer.

The Committee was concerned that, although the re-analysis of the data indicated that there might be a beneficial effect on survival for patients whose tumour cells had high levels of EGFR, there were some concerns, particularly over the way that patients had been categorised into high- or low-EGFR-level groups in the retrospective analysis, as well as the fact that the effect seen in patients with high EGFR levels in the main study had not been confirmed in another study. Therefore, at the time of the withdrawal, the CHMP concluded that the medicine could not have been approved based on the data presented by the company and that further studies were required to confirm the benefit of Erbitux in patients whose tumour cells have high EGFR levels.

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

In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided so far are not sufficient to address CHMP’s concerns and that more data will be needed.

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 were no ongoing clinical trials with Erbitux in non-small-cell lung cancer at the time of the withdrawal.

What is happening with Erbitux for the treatment of other diseases?

There are no consequences on the use of Erbitux 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 Erbitux (cetuximab) BG = bălgarski 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) ES = español 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) CS = čeština 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) DA = dansk 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) DE = Deutsch 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) ET = eesti keel 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) EL = elliniká 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) EN = English 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) FR = français 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) IT = italiano 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) LV = latviešu valoda 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) LT = lietuvių kalba 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) HU = magyar 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) MT = Malti 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) NL = Nederlands 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) PL = polski 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) PT = português 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) RO = română 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) SK = slovenčina 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) SL = slovenščina 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) FI = suomi 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) SV = svenska 2012-10-12  

Press release

Merck KGaA withdraws its application for an extension of the indication for Erbitux (cetuximab)

The European Medicines Agency has been formally notified by Merck KGaA of its decision to withdraw its application for an extension of the therapeutic indication for the centrally authorised medicine Erbitux (cetuximab), 5-mg/ml solution for infusion.

On 18 March 2011, Merck KGaA submitted an application to extend the marketing authorisation for Erbitux to the treatment of non-small-cell lung cancer (NSCLC). At the time of the withdrawal, the application was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).

Erbitux was first authorised in the European Union on 29 June 2004 and it is currently indicated for the treatment of patients with epidermal-growth-factor receptor (EGFR)-expressing, KRAS-wild-type metastatic colorectal cancer It is also indicated for the treatment of patients with squamous-cell cancer of the head and neck.

In its official letter, the company stated that it decided to withdraw the application because the data currently available suggest that further data will be required to overcome the uncertainties raised by the CHMP.

Erbitux continues to be authorised in the currently approved indications.

More information about Erbitux 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 17-20 September 2012 CHMP meeting.

Note

  • Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.
Name Language First published Last updated
Merck KGaA withdraws its application for an extension of the indication for Erbitux (cetuximab) (English only) 2012-09-19  

Key facts

Product details for Erbitux
NameErbitux
Product numberEMEA/H/C/000558
Date of issue of marketing authorisation valid throughout the European Union (if applicable)29/06/2004
International non-proprietary name or common name

cetuximab

Active substancecetuximab
Date of withdrawal17/09/2012
Company making the application

Merck KGaA

Withdrawal typePost-authorisation

All documents

Name Language First published Last updated
Withdrawal assessment report for Erbitux (English only) 2012-11-22  
Withdrawal letter: Erbitux (cetuximab) (English only) 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) BG = bălgarski 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) ES = español 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) CS = čeština 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) DA = dansk 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) DE = Deutsch 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) ET = eesti keel 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) EL = elliniká 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) EN = English 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) FR = français 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) IT = italiano 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) LV = latviešu valoda 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) LT = lietuvių kalba 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) HU = magyar 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) MT = Malti 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) NL = Nederlands 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) PL = polski 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) PT = português 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) RO = română 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) SK = slovenčina 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) SL = slovenščina 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) FI = suomi 2012-10-12  
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) SV = svenska 2012-10-12  
Merck KGaA withdraws its application for an extension of the indication for Erbitux (cetuximab) (English only) 2012-09-19