ImClone Systems and Bristol-Myers Squibb says that they will delay filing their colorectal cancer agent, Erbitux (cetuximab), with the US Food and Drug Administration as a possible treatment for head and neck cancer to give them more time to analyse data from a pivotal clinical trial.
The firms had originally hoped to file the product for the green light in this new indication in the second quarter of 2005, but say they still hope to complete the filing before the end of the year.
Specifically, the companies want to “strengthen the process by which the primary endpoint” of the so-called IMC-9815 is being evaluated by the 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.
This is not the first setback Erbitux has faced, and its route to first US approval was dogged by an insider trading scandal at ImClone, which resulted in the imprisonment of the firm’s former chief executive, Sam Waskal, and lifestyle guru, Martha Stewart [[13/02/04b]], [[13/06/02a]].