Merck KGaA Erbitux Trial Designed With FDA Feedback On ImClone U.S. Trials
Merck KGaA's Erbitux Phase II trial in colorectal cancer will benefit from FDA feedback on ImClone's earlier U.S. trial designs, ImClone Chief Operating Officer Harlan Waksal said
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ImClone may refile its Erbitux BLA in colorectal cancer using data from studies conducted by Merck KGaA, which holds the European rights to cetuximab
ImClone expects to resubmit the BLA for Erbitux (cetuximab) during the first quarter after addressing the issues raised in FDA's "refuse-to-file" letter for the colorectal cancer treatment