Merck Submits New Indication Application for Cetuximab (Erbitux) in China

Source: PharmaCube Info

Author: Sunshine

On November 3, the CDE website indicated that Merck has submitted a marketing authorization application for a new indication of cetuximab (trade name: Erbitux).

Cetuximab is a chimeric human-mouse IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR) and is the first anti-EGFR monoclonal antibody approved for marketing worldwide. It specifically binds to the extracellular domain of EGFR expressed on the surface of cancer cells, competitively inhibits corresponding ligands, and blocks intracellular signaling pathways, thereby exerting antitumor effects; kills tumor cells via antibody-dependent cell-mediated cytotoxicity (ADCC); and downregulates hypoxia-inducible factor-1α (HIF-1α) and the Bcl-2 proto-oncogene while activating autophagy-related genes, thereby inducing autophagy in tumor cells.

In February 2004, cetuximab was first approved for marketing in the United States, followed by subsequent approvals in the European Union, China, and Japan. Currently, cetuximab has been approved in over 100 countries worldwide and is primarily indicated for the treatment of colorectal cancer and squamous cell carcinoma of the head and neck (SCCHN).

In September 2021, cetuximab received an expanded indication in the United States, specifically for use in combination with encorafenib for the treatment of previously treated patients with BRAF V600E mutation-positive metastatic colorectal cancer (CRC). Cetuximab was originally developed by ImClone, with rights jointly held by Merck KGaA, BMS, and Eli Lilly.

Note: The original text has been abridged.