Merck KGaA gets second CHMP rejection for Erbitux in Advanced Non-Small Cell Lung Cancer

For the second time this year, 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 German drug major Merck KGaA's 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).
The CHMP previously rejected Erbitux in this lung cancer indication in July 2009, stating that the benefits of therapy did not outweigh the risks but, following an appeal from Merck, reviewed the application (The Pharma Letter July 31).

Given the efficacy and significant overall survival benefit of Erbitux in NSCLC as demonstrated in the pivotal, randomized Phase III FLEX study, Merck says it is 'disappointed that NSCLC patients in Europe will not get to benefit from Erbitux.'

Although the company says that it will now halt the lung cancer studies, it '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.'

Erbitux, which Merck believes has blockbuster potential with more than 1 billion euros ($1.49 billion) in peak annual sales even without lung cancer revenue, is already approved for use against cancer of the bowel and of the head and neck. US drug majors Bristol-Myers Squibb and Eli Lilly hold the rights to Erbitux in the USA and Canada.

The drug, which was developed by the USA's ImClone Systems and licensed to the US and German firms, has seen controversy before when, in 2002, the US Food and Drug Administration expressed reservations about ImClone' Biologics License Application for Erbitux in the treatment of colorectal cancer, which might have run deeper than first thought., and even led to the then chief executive of the company's resignation, after Sam Waksal acknowledged at the JP Morgan H&Q health care conference that the company had made a blunder and had assembled a "faulty" BLA.

Merck's shares closed down 2.4% at 65.56 euros on the news on November 19. "This is very bad news for Merck and puts immense pressure on the shares," said Andrew Baum, an analyst with Morgan Stanley in Germany quoted by Reuters, who rates the stock "underweight." The setback limited growth opportunities for the drug at a time when Erbitux was already facing growing competition, he argue, noting that US biotechnology giant Amgen's EGFR-inhibitor Vectibix (panitumumab) is likely to be approved in first- and second-line metastatic bowel cancer in 2010.