Comparability Issues Interfere with Another Erbitux Fiing

March 13, 2009

ImClone Systems, a subsidiary of Eli Lilly and Company (Indianapolis, Indiana), and Bristol-Myers Squibb (BMS, New York, NY), have received a complete response letter from the US Food and Drug Administration for the first-line squamous cell carcinoma of the head and neck supplemental Biologics License Application (sBLA) for Erbitux (cetuximab).

ImClone Systems, a subsidiary of Eli Lilly and Company (Indianapolis, Indiana), and Bristol-Myers Squibb (BMS, New York, NY), have received a complete response letter from the US Food and Drug Administration for the first-line squamous cell carcinoma of the head and neck supplemental Biologics License Application (sBLA) for Erbitux (cetuximab).

The FDA is requesting an additional pharmacokinetic study to confirm the comparability of the Erbitux used in the first-line head and neck submission as compared to Erbitux currently marketed in the US. Clinical supplies used in this sBLA were provided by Merck KGaA (Whitehouse Station, NJ), ImClone’s partner for Erbitux outside of North America.

As previously announced, ImClone and BMS recently withdrew the advanced non-small cell lung cancer sBLA for Erbitux because of the same problem. (See the February BioPharm bulletin.)In both cases, the companies are continuing to work with the FDA to confirm pharmacokinetic comparability.

The companies’ discussions with the FDA do not have any effect on currently marketed Erbitux, including the safety and efficacy of the product for approved indications.