Flatiron Health Real-World Data Support FDA Approval of New Dosing Regimen for ERBITUX® (cetuximab)

Published by W Butcher on

Flatiron Health real-world data (RWD) supported the U.S. Food and Drug Administration (FDA)’s recent approval of a new dosing regimen for ERBITUX® (Eli Lilly and Company’s cetuximab) that can have a direct positive impact on the lives of patients with metastatic colorectal cancer (CRC) or squamous cell carcinoma of the head and neck (SCCHN). The FDA approved a supplemental biologics license application (sBLA) for ERBITUX which provides a new, biweekly dosing regimen for the medicine’s indicated use in patients with K-Ras wild-type, EGFR-expressing metastatic CRC or SCCHN, when used as a single agent or in combination with chemotherapy. This alternate dosing regimen to the previously approved weekly dosing regimen allows ERBITUX infusions to be scheduled alongside other biweekly treatments, significantly reducing the frequency of patient visits to an infusion center.

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