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news.ImClone Systems and Bristol-Myers Squibb have revealed that their filing seeking FDA approval for Erbitux in head and neck cancer will be delayed, sending ImClone's stock down by over 11%.
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The two companies had intended to submit a supplemental biologics license application (sBLA) for Erbitux (cetuximab) as a single agent and in combination with radiation in squamous cell carcinoma of the head and neck (SCCHN) in Q2 2005. The submission date will now be later this year.
ImClone and BMS said the delay is due to the need for extra time to strengthen the process by which the primary endpoint of Study IMC-9815 is evaluated by independent reviewers. The review of the secondary endpoint of the study, survival, and the data from the second pivotal study, EMR-016, are not subject to this independent review process.
The companies said that they remain confident the filing will be completed with all the data originally expected to be submitted.