FDA asks for PK study before approving Erbitux sBLA

The Food and Drug Administration says it needs to see results from a  pharmacokinetics study before it can approve a supplemental Biologics  License Application for Erbitux (cetuximab) in first-line squamous cell  carcinoma of the head and neck. The sBLA was accepted for filing and  granted a priority review status in October 2008. In the complete  response letter that the FDA sent to the makers of the drug, ImClone  Systems, a subsidiary of Eli Lilly, and Bristol-Myers Squibb, it said  that it needs PK data to confirm the comparability of Erbitux in the  proposed indication versus the drug as it is currently marketed in the  USA. Clinical supplies used in this sBLA were provided by Germany's  Merck KGaA, ImClone's partner for Erbitux outside North America.