Orshe

A European Medicines Agency committee did the unexpected late yesterday, recommending that the cancer drug Erbitux be rejected as a treatment for non-small-cell lung cancer.

That caught the investment community by surprise, according to DJ Newswires and Bloomberg. A Q&A about the refusal was posted on the European Union regulator’s Web site today.

Shares of Merck KGaA, which markets Erbitux in Europe, were down over 14% in today’s trading in Frankfurt. Investors also weren’t pleased with second quarter earnings posted by the German company, which isn’t related to U.S.-based Merck. Bristol-Myers and Eli Lilly, which co-market Erbitux in the U.S., were relatively unaffected in early New York Stock Exchange Trading.

Merck thought the committee might impose some restrictions on the product’s use, as both the EU and U.S. regulators have required for Erbitux treatments in other patient populations.

“We never detected that a no-approval could be an option,” Elmar Schnee, chief of Merck’s drugs unit, said on a conference call with analysts. Merck will appeal the decision but expects a year’s delay in the drug launch even if Erbitux is approved for this use, notes DJ Newswires.

The committee felt that the benefits of Erbitux, when added to chemotherapy, were “modest in terms of survival times” and didn’t appear to slow down the cancer. And, side effects for patients could be severe, according to the document released today.

“The benefits of Erbitux in the treatment of non-small cell lung cancer did not outweigh its risks,” wrote the committee.

Read the rest here: 
Europe Gives Thumbs-Down to Erbitux for Treating Lung Cancer