Erbitux Companion Test Approval Clears Path For Further R&D Alliances
This article was originally published in The Pink Sheet Daily
Oncologic drug/diagnostic markers show further room for co-development, as demonstrated by the pairing of the colorectal cancer drug Erbitux and DakoCytomation's EGFR pharmDx. ImClone drug reimbursement trends likely will drive uptake of the diagnostic.
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Two of 13 total postmarketing commitments involve studying the efficacy of Erbitux in patients with EGFR-negative colorectal cancer. Other Phase IVs include a dose finding study in the pediatric population.
Genzyme expects to complete enrollment of its Phase II myoblast cardiac therapy trial by late 2006. While the clinical trials are ongoing, the company will outfit Medtronic’s TransAccess catheter for myoblast delivery. CBER likely would review the combination product.