OBR Daily Commentary


FDA Approves New Dosing Regimen For Cetuximab

(FDA.gov) Apr 7, 2021 - On April 6, 2021, the Food and Drug Administration approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab (Erbitux, ImClone LLC) for patients with K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN). This approval provides for a biweekly dosage regimen option in addition to the previously approved weekly dosage regimen for the approved indications when cetuximab is used as a single agent or in combination with chemotherapy.

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Howard S. Hochster, MD (Posted: April 07, 2021)


"UPDATE": I am glad the FDA caught up with itself. The dosing regimen for Cetuximab was approved by the FDA in the ECOG E7208 trial more than a decade ago (actually in 2009). This will at least stop pharma trials from requiring patients to come in every week for a drug that can be given every 2 weeks!



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