FDA Approves New Every-Two-Week Dosing Regimen for Eli Lilly's Erbitux in Head and Neck and Metastatic Colorectal Cancers

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Recently, the U.S. FDA approved a new dosing regimen for Eli Lilly’s targeted anticancer drug Erbitux (cetuximab): 500 mg/m² administered as a 120-minute intravenous infusion every two weeks (Q2W), for the treatment of K-Ras wild-type, EGFR expression-positive metastatic colorectal cancer (mCRC) and squamous cell carcinoma of the head and neck (SCCHN). This approval came approximately five months ahead of the FDA’s previously set target date.

In addition to the previously approved once-weekly dosing regimen, this latest approval provides clinicians and patients with a once-every-two-weeks dosing option for Erbitux as monotherapy or in combination with chemotherapy.

This approval is based on population pharmacokinetic (PK) modeling analysis. This analysis compared the predicted exposure of Erbitux 500 mg administered every two weeks (Q2W) with the observed Erbitux exposure in patients receiving weekly Erbitux 250 mg therapy. The application was further supported by a pooled analysis of overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) from published literature in patients with colorectal cancer (CRC) and squamous cell carcinoma of the head and neck (SCCHN), as well as an OS analysis using real-world data in patients with metastatic CRC (mCRC) treated with either the weekly Erbitux 250 mg regimen or the Q2W 500 mg regimen. In these exploratory analyses, the observed efficacy outcomes were consistent across different dosing regimens and supported the results of the population PK modeling analysis.

The most common adverse reactions to Erbitux (incidence ≥25%) are skin-related adverse reactions (including rash, pruritus, and nail changes), headache, diarrhea, and infection.

Additional safety and efficacy information for Erbitux, along with the recommended dosage regimen, has been incorporated into the updated full prescribing information for Erbitux.

Erbitux is the first monoclonal antibody targeting EGFR worldwide and, to date, has been approved for marketing in more than 100 countries globally. Erbitux was developed by ImClone Systems, which was acquired by Eli Lilly and Company in 2008 for $6.5 billion. According to the U.S. labeling information, Erbitux was launched in the United States in 2004. Its approved indications include:

— Head and Neck Cancer: (1) In combination with radiotherapy for the initial treatment of patients with locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN); (2) In combination with platinum-based regimens and fluorouracil for the treatment of patients with recurrent locoregional disease or metastatic SCCHN; (3) For the treatment of patients with recurrent or metastatic SCCHN whose disease has progressed after platinum-based therapy.

—Colorectal Cancer: Indicated for the treatment of patients with metastatic colorectal cancer (CRC) confirmed as K-Ras wild-type and EGFR expression-positive by FDA-approved diagnostic tests. Specific indications include: (1) in combination with FOLFIRI (irinotecan, 5-fluorouracil, and leucovorin) for first-line treatment; (2) in combination with irinotecan for patients refractory to irinotecan-based chemotherapy; (3) as monotherapy for patients who have failed oxaliplatin-containing or irinotecan-containing regimens and are intolerant to irinotecan.

Reference source: FDA approves new dosing regimen for cetuximab