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As of Nov 13, 2026, BLA 125084 (Erbitux), held by Imclone, was first approved by FDA on Feb 12, 2004, with 26 approved supplements and 0 published complete response letters.
First approved: Feb 12, 2004
Review: Priority
Supplements approved: 26
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1, 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. ( 1.1, 14.1 ) Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. ( 1.1, 14.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
