FDA approves new Erbitux dosing regimen for colorectal, head and neck cancers
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The FDA approved a new cetuximab dosage regimen for the treatment of patients with KRAS wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck, according to a press release.
The new cetuximab (Erbitux; ImClone, Eli Lilly) regimen — 500 mg/m2 as a 120-minute IV infusion every 2 weeks — provides a biweekly option in addition to the previously approved weekly regimen as a single agent or in combination with chemotherapy.
The FDA based this approval on population pharmacokinetic modeling analyses that compared predicted exposure of cetuximab among patients who received the biweekly dose compared with observed exposures of those who received 250 mg/m2 weekly.
A review of pooled analyses of published data on overall response rates, PFS and OS among patients with colorectal cancer and HNSCC, and real-world OS data among patients with colorectal cancer, showed consistent efficacy across the doses and supported the results of the population pharmacokinetic modeling analyses, according to the press release.
Common adverse events associated with cetuximab include cutaneous reactions, headache, diarrhea and infection.
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