FDA rejects approval application from Bristol-Myers Squibb, ImClone Systems

NEW YORK The Food and Drug Administration has rejected an approval application from Bristol-Myers Squibb and Eli Lilly & Co. subsidiary ImClone Systems for an additional use of a cancer drug, the two companies announced Monday.

In its letter, the FDA requested an additional study to confirm the comparability of Erbitux (cetuximab) used as a first-line treatment for squamous cell carcinoma of the head and neck in the rejected approval application as compared to Erbitux marketed in the United States. The companies used supplies of Erbitux provided by German drug maker Merck KGaA, which markets Erbitux outside of North America.

Bristol and ImClone recently withdrew an application seeking approval for Erbitux as a treatment for advanced non-small cell lung cancer, also because the FDA needed a comparability study. The FDA’s decisions do not affect Erbitux already marketed in the U.S.