With the targeted oncology drug Erbitux® (cetuximab), Merck Serono has not only considerably increased the number of treatment options available in colorectal cancer, but also opened up new medical prospects in the treatment of head and neck cancer as well as lung cancer. In 2008, our Oncology business unit generated sales of € 574 million. The majority share was attributable to Erbitux®, which achieved a 20% increase in sales to € 565 million. Erbitux® currently holds marketing authorizations in 76 countries worldwide.
In July, the European Commission approved the expanded use of Erbitux® in combination with chemotherapy to include not only second- and third-line treatment but also first-line treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer. Patients with KRAS wild-type tumors, which occur in up to 65% of cases, are most likely to respond to Erbitux®, making this drug the first tailored therapy in first-line treatment of metastatic colorectal cancer. As expected, the sales growth rate of Erbitux® slowed from the second to the third quarter of 2008. This was due to the fact that KRAS testing had to be implemented as a standard diagnostic procedure. Accordingly, the number of second- and third-line patients initially declined as a result of the focus on patients with KRAS wild-type tumors. In the course of expanded approval, we expect prescriptions for first-line treatment to increase, thereby more than compensating for the lower number of patients in second- and third-line treatment over the medium term. A crucial factor is that reimbursement in different countries is being granted at different points in time.
Further approvals of Erbitux®
In November, Erbitux® was approved in the European Union in combination with platinum-based chemotherapy for treatment of head and neck tumors. This approval is based primarily on the results of the EXTREME study, showing for the first time in 30 years a significant survival advantage in first-line treatment setting. In addition, we received marketing authorization in Japan for the use of Erbitux® in combination with irinotecan in metastatic colorectal cancer – giving pretreated patients access to this new treatment. Merck Serono, Bristol-Myers Squibb and ImClone Systems jointly market Erbitux® in Japan. Our marketing partners receive 50% of profits.
We are working to further expand the range of approved indications for Erbitux®. For example, we submitted an application to the European Medicines Agency (EMEA) to approve Erbitux® for first-line treatment of epidermal growth factor receptor (EGFR)-expressing, advanced non-small cell lung cancer (NSCLC).
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