Germany-based pharmaceutical firm Merck KGaA announced that China’s National Medical Products Administration (NMPA) has issued market approval for a new indication for the epidermal growth factor receptor (EGFR) inhibitor Erbitux (cetuximab). The approval allows Erbitux to be used in combination with radiotherapy for treating locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).
Clinical Trial Basis
The approval is based on the global Phase III Bonner study, which demonstrated that cetuximab in combination with radiotherapy significantly improved local control and prolonged overall survival compared to radiotherapy alone. The study showed a three-year local control rate of 47% and a five-year overall survival rate of 45.6% for patients treated with Erbitux and radiotherapy, both significantly better than the radiotherapy-alone group. The combination did not increase toxicity or negatively impact quality of life.
Subgroup Analysis Insight
A subgroup analysis of the Bonner study first pointed out the potential benefit of Erbitux for laryngeal preservation in patients with squamous cell carcinoma of the head and neck (SCCHN).
Drug’s Market Background
Merck struck a deal with ImClone (now owned by Eli Lilly) in 1998, obtaining exclusive rights to Erbitux outside of the US and Canada. Erbitux, approved for use in SCCHN in more than 100 countries, received approval in China in December 2005. It was included in China’s National Reimbursement Drug List (NRDL) in 2018 through a special anti-tumor drug negotiation program. The drug gained further approvals in China for first-line RAS wild-type metastatic colorectal cancer and first-line recurrent and/or metastatic SCCHN in combination with platinum-based therapy with fluorouracil in 2019 and 2020, respectively.-Fineline Info & Tech
