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Date: 2011-12-19

Type of information: Granting of a patent

Product name: Erbitux®

Compound: cetuximab

Therapeutic area: Cancer - Oncology

Action mechanism:

IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). Its binding to the EGFR inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors.

Company: Merck KGaA (Germany)

Disease:

advanced or metastatic non-small cell lung cancer (NSCLC) with high epidermal growth factor receptor (EGFR) expression.

Latest news:

* On March 30, 2011, Merck KGaA announced that it has submitted an indication extension to the European Medicines Agency (EMA) for the approval of Erbitux® (cetuximab) in combination with standard first-line platinum-based chemotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with high epidermal growth factor receptor (EGFR) expression.
The submission is based on a new biomarker analysis of EGFR expression levels in tumors of patients participating in the Phase III FLEXa study. New data, presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology in December 2010, showed that, among patients with high EGFR expression, the response rate was significantly increased by the addition of Erbitux to standard chemotherapy from 28.1% to 44.4% (p=0.002).i Merck analyzed further clinical data for the submission and plans to present additional results at upcoming congresses.
* On September 19, 2012, the European Medicines Agency (EMA) has announced that it 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.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE: 2011-03-18

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE: 2012-09-19

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes