FDA Requests More Information on Erbitux sBLA

ImClone Systems, an Eli Lilly subsidiary, and Bristol-Myers Squibb received an FDA complete response letter for an sBLA seeking an Erbitux indication for the first-line treatment of squamous cell carcinoma of the head and neck. The FDA asks for an additional pharmacokinetic study to confirm that the supply of Erbitux (cetuximab) used in trials supporting the proposed indication is comparable with the version of the drug sold in the U.S.
Drug Industry Daily