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Erbitux head/neck cancer sBLA delay

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bristol-Myers Squibb and ImClone will delay submission of Erbitux (cetuximab) for head and neck cancer until the end of the year to allow for an independent review of a pivotal Phase III study (IMC-9815). The companies originally planned a second-quarter submission. The delay is needed "to conduct additional and independent analysis of the primary endpoint of...locoregional control," ImClone Chief Medical Officer Eric Rowinsky explained during an April 13 conference call. The trial's secondary endpoint of survival will not be subject to independent review, according to the company...

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