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Erbitux head/neck cancer sBLA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bristol-Myers Squibb and ImClone are requesting a priority review for their Aug. 29 Erbitux (cetuximab) sBLA for treatment of squamous cell carcinoma of the head and neck. The application proposes use in combination with radiation in locally or regionally advanced disease where platinum-based chemotherapy has failed or is inappropriate. The submission comes after the sponsors' June announcement that they would delay the sBLA until an independent review confirmed the positive results of a pivotal Phase III trial (1Pharmaceutical Approvals Monthly July 2005, p. 27). ImClone has also filed a marketing authorization application in Europe for the indication...
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