Merck KGaA wants a redo. The German drugmaker is appealing last week's rejection of Erbitux as a lung-cancer treatment, hoping that it can get the nod for at least a subset of those patients. "Merck will work closely with the CHMP to unravel the value of Erbitux for patients benefit most," the company said in a statement.
The FDA recently added language to Erbitux's label, saying it was only recommended for use in colon cancer patients without a particular gene mutation. Previous research has shown that Erbitux is less effective in cancers with EGFR mutations, so Merck might tailor its approval request using that data.
The lung cancer approval is seen as key for growth in European Erbitux sales. Analysts had predicted that the drug could deliver $358 million in annual sales for the disease.
- read the Merck release
- get the Bloomberg article