BioCentury
ARTICLE | Product Development

Delaying gratification with Erbitux

April 29, 2002 7:00 AM UTC

Merck KGaA's decision to delay submission of an MAA for Erbitux cetuximab may end up getting it to market almost as fast and with a broader indication, due to quirks in the European regulatory system.

After a recent meeting to assess the progress of a European Phase II trial of cetuximab in colorectal cancer, Merck (FSE:MRK, Darmstadt, Germany) decided to postpone what was to have been a late 2002 European filing for head and neck cancer. Instead, the company now will seek simultaneous approval of both indications in the first half of 2003. ...