Press Release

Geneva, Switzerland, November 19, 2009 – The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has adopted a negative opinion for the use of Erbitux® (cetuximab) 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).

Given the efficacy and significant overall survival benefit of Erbitux in NSCLC as demonstrated in the pivotal, randomized Phase III FLEXa study, Merck Serono (a division of Merck KGaA, Darmstadt, Germany) is disappointed that NSCLC patients in Europe will not get to benefit from Erbitux.

The company remains committed to the clinical development program for Erbitux, which includes clinical trials investigating the potential of the therapy in the treatment of various cancer types.

About lung cancer
In Europe, lung cancer is the leading cause of death from cancer (20% of all cancer deaths).1 NSCLC accounts for approximately 80% of all lung cancer cases.2 At diagnosis, most patients with NSCLC present with advanced, non-operable (also called unresectable) disease, which is associated with a very poor prognosis.3 The overall 5-year survival rate for lung cancer is about 10%, compared to 81% for melanoma and 75% for breast cancer.4

a FLEX: First-Line ErbituX in lung cancer
References
1. European Lung Foundation. www.european-lung-foundation.org/index.php?id=65.
2. D’Addario G, et al. Ann Oncol 2008;19(Suppl 2):ii39-40.
3. Bunn PA, et al. Oncologist 2008;13(Suppl 1):1-4.
4. Sant M, et al. Ann Oncol 2003;14(Suppl 5):v61-118.
 

For more information on Erbitux in colorectal, head & neck and non-small cell lung cancer, please visit: www.globalcancernews.com.

For more information:
http://www.merckserono.com/corp.merckserono/en/images/20091119_en_tcm112_45291.pdf