The targeted oncology drug Erbitux® (cetuximab) is currently approved for use in colorectal cancer in 90 countries and in head and neck cancer in 88 countries. It is used as a standard treatment in combination with chemotherapy for all lines of therapy or as a monotherapy for pretreated patients in epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer (mCRC). In addition, the monoclonal antibody is a standard first-line therapy for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) in combination with platinum-based chemotherapy, as well as in combination with radiotherapy for locally advanced head and neck cancer. We are exploring further indications in additional studies. Sales of Erbitux® rose by 4.3% to € 855 million in 2011.
In the first half of 2011, we sustained a decline in sales in Japan. This was attributable to increased competitive pressure and the introduction of the KRAS biomarker test, which, in line with our commitment to personalized cancer therapy, was introduced after label expansion into first-line metastatic colorectal cancer. As of the third quarter, sales in Japan began to stabilize and then to recover slowly. Sales in the rest of Asia as well as Latin America rose markedly; Europe also saw slight growth.
In March, we submitted an indication extension application to the European Medicines Agency (EMA). The application relates to the indication for Erbitux® 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. We have established the latter as a predictive biomarker for Erbitux® in the disease. In 2009, the Committee for Medicinal Products for Human Use (CHMP) of the EMA previously adopted a negative opinion on the use of Erbitux® in NSCLC.
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