Eli Lilly's Erbitux new dosing regimen is approved by the U.S. FDA for head and neck cancer and colorectal cancer

Compilenewborn

Recently, the US FDA approved a new dosage regimen of Eli Lilly’s targeted anticancer drug Erbitux (cetuximab, cetuximab): 500mg/m2 as a 120-minute intravenous infusion, once every 2 weeks (Q2W), for treatment K-Ras wild-type, EGFR-positive metastatic colorectal cancer (mCRC) and squamous cell carcinoma of the head and neck (SCCHN).

When Erbitux is used as a monotherapy or combination chemotherapy, in addition to the previously approved weekly dosage regimen, the latest approval will provide clinicians and patients with an option of a biweekly dosage regimen.

The approval is based on population pharmacokinetic (PK) modeling analysis.

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

Erbitux’s additional safety and efficacy information, as well as the recommended dosage regimen, have been included in the updated complete Erbitux prescribing information.

Erbitux is the world's first monoclonal antibody targeting EGFR.

——Head and neck cancer: (1) Combined radiotherapy for the initial treatment of patients with locally or regionally advanced SCCHN; (2) Combined platinum regimen and fluorouracil for the treatment of patients with recurrent regional disease or metastatic SCCHN; (3) Used for Treat patients with recurrent or metastatic SCCHN who have progressed after receiving platinum regimens.

——Colorectal cancer: used for the treatment of metastatic CRC patients with K-Ras wild-type and EGFR positive expression confirmed by FDA-approved testing products.

Reference source: FDA approves new dosing regimen for cetuximab