Merck KGaA Erbitux Trial Designed With FDA Feedback On ImClone U.S. Trials
Executive Summary
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
You may also be interested in...
Bristol/ImClone Erbitux BLA Timeline Depends On Merck KGaA Phase II Study
ImClone's timeline for refiling its Erbitux BLA hinges on completion of Merck KGaA's Phase II study in colorectal cancer patients
ImClone Erbitux Options: Add EU Colorectal Data, Refile As Head & Neck BLA
ImClone may refile its Erbitux BLA in colorectal cancer using data from studies conducted by Merck KGaA, which holds the European rights to cetuximab
Bristol/ImClone Erbitux BLA Resubmission Expected During First Quarter
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