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Home » ImClone Systems, BMS Amend Timeline for Erbitux sBLA Filing
ImClone Systems, BMS Amend Timeline for Erbitux sBLA Filing
ImClone Systems and Bristol-Myers Squibb intend to file a supplemental biologics license application (sBLA) to seek approval of Erbitux (Cetuximab) for use as a single agent and in combination with radiation in squamous cell carcinoma of the head and neck with the FDA before the end of the year.
The companies had previously announced they intended to submit an sBLA in the second quarter of 2005.
KEYWORDS Drug Pipeline Alert
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