The European Union has rejected Erbitux drug for treatment of lung cancer, denting growth prospects for the company's top-selling oncology treatment.
European regulators were concerned that Erbitux provided only a "modest" benefit to lung-cancer patients when added to standard chemotherapy, according to a statement posted today on the drug agency's Web site. Some patients experienced severe side effects, regulators said.
Advertisement"The benefits of Erbitux in the treatment of non-small cell lung cancer did not outweigh its risks," the statement said.
The decision of the European Medicines Agency's Committee for Medicinal Products for Human Use was unexpected, observers said.
"It means Erbitux is either significantly delayed or won't ever make it to market" for lung cancer, Fabian Wenner, a Zurich-based analyst for UBS AG, wrote in a note to investor.
Merck, the German drug giant, said it's considering appealing the regulatory opinion on Erbitux, which the company already sells to treat colorectal and head and neck cancers. They are not affiliated with Merck & Co. of the U.S.
The drug is sold in the U.S. by Bristol-Myers Squibb Co. and Eli Lilly & Co. Wolfgang Wein, Merck's executive vice president of oncology, said in a May interview that sales of the drug outside the U.S. should reach 1 billion euros a year by 2010 or 2011. That goal may take longer to reach now, the company said today.
"We never detected that a no-approval could be an option," Elmar Schnee, who heads Merck's drugs unit, said on a conference call with analysts. "I am puzzled how you can come to this conclusion for this severe disease with the dossier we provided."
The company thought regulators might ask for restrictions on the drug's use instead, he said.
The rejection "has wider implications than just for Merck," Robert Pirker, lead investigator of the company's FLEX trial and a professor at the Medical University of Vienna said in an e-mailed statement. "When a therapy that has met its primary end point and increases overall survival is rejected, it sends a negative signal to the whole industry as to why companies should invest in lung cancer."
Merck has also asked European regulators to approve the multiple sclerosis medicine cladribine, potentially the first treatment in pill form for the debilitating central nervous system disease. The company announced in June it had begun late- stage clinical testing on the experimental vaccine Stimuvax, which could be the first shot against lung cancer, Bloomberg reported.