ImClone Systems and Bristol-Meyers Squibb Company have withdrawn their supplemental biologics application (sBLA) from the U.S. Food and Drug Administration (FDA) for Erbitux® (cetuximab) to be used in the treatment of non-small cell lung cancer (NSCLC).
Following discussion with the FDA, the sBLA was withdrawn based upon comparability of the U.S. marketed version of Erbitux with the clinical supplies used by Merck KGaA, which is the partner for Erbitux outside of North America. A resubmission of the sBLA is planned pending resolution of this matter.
The withdrawal of the sBLA for lung cancer has no impact on Erbitux in its currently approved indications for colorectal and head and neck cancer.
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