Our targeted oncology drug Erbitux® (cetuximab) is approved 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 used to treat 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. Erbitux® is currently approved for use in colorectal cancer in 78 countries and in head and neck cancer in 73 countries. We are exploring further indications in additional studies.
In 2009, sales of Erbitux® continued on a growth course, increasing by 23% to € 697 million. This reflects a considerable improvement over the last two quarters of 2008. Over the past two years, the testing of the KRAS status of mCRC tumors has been successfully established as a standard diagnostic tool and is now widely available. This development underscores our strong position in the field of personalized medicine.
In the United Kingdom, the National Institute for Health and Clinical Excellence (NICE) recommended in June the use of Erbitux® in combination with chemotherapy as a first-line treatment for patients with metastatic colorectal cancer who have met specific additional criteria – improving the possibility of potentially curative surgery. Erbitux® is the only targeted therapy endorsed by NICE for the first-line treatment of the disease. A recommendation of this kind is a prerequisite in the United Kingdom for funding of a medical treatment by the National Health Service.
Breakthrough in head and neck cancer
Subsequent to receiving approval in November 2008, we launched Erbitux® in January 2009 in the EU for the first-line treatment of recurrent or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based standard chemotherapy. Approval of this new indication was based on the results of the EXTREME study, which was the first trial in 30 years to demonstrate a significant overall survival benefit in the first-line setting. The 2009 guidelines of the European Society for Medical Oncology (ESMO), which recommend Erbitux® as the most suitable treatment in recurrent and/or metastatic and locally advanced head and neck cancer, represent a further milestone.
Negative opinion on Erbitux® in non-small-cell lung cancer
In November, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion for the use of Erbitux® in combination with platinum-based chemotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, advanced or metastatic non-small-cell lung cancer (NSCLC). This followed an initial negative opinion issued by this scientific committee of the European Medicines Agency EMA (previously: EMEA) in July. Merck requested reexamination of this opinion because the Phase III FLEX study had shown that in first-line treatment, Erbitux® significantly increased overall survival in patients with non-small-cell lung cancer across all histologies. We respect the decision of the CHMP; nevertheless, we remain committed to our clinical development program designed to tap the potential of Erbitux® in the treatment of various cancer types, including gastric cancers.