Merck KGaA has been hit by the news that advisors to Europe’s regulators have again rejected Erbitux as a treatment for advanced lung cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a negative opinion that was originally issued in July for the use of Erbitux (cetuximab) in combination with platinum-based chemotherapy for the treatment of patients with epidermal growth factor receptor-expressing metastatic non-small cell lung cancer. Merck had hoped that the CHMP would reconsider “the efficacy and significant overall survival benefit of Erbitux in NSCLC” as demonstrated in the Phase III FLEX study, but the committee was not convinced.

The German firm said it is “disappointed that NSCLC patients in Europe will not get to benefit from Erbitux”. Following the July rejection, Merck said it is convinced the drug “will play a major role in NSCLC as it is the first and only compound in clinical development in more than 10 years to increase overall survival in a patient population including all histologies”.

The company will now end the lung cancer studies but said it “remains committed to the clinical development programme for Erbitux” in the treatment of various cancer types. The drug is currently approved for colorectal, as well as head and neck cancers.

Andrew Baum, an analyst at Morgan Stanley, issued a research note saying the news is a setback as it limits growth opportunities for Erbitux which could soon be facing significant competition. Specifically, he noted that Amgen's EGFR-inhibitor Vectibix (panitumumab) is likely to be approved in first- and second-line metastatic bowel cancer in 2010, hitting Erbitux's market share and eroding prices.
Bristol-Myers Squibb and Eli Lilly hold the rights to Erbitux in North America.