Merck's Erbitux® (cetuximab) gains new indication for colorectal cancer in China
On October 13, Merck KGaA announced that its Cetuximab Solution for Infusion (Erbitux®, Chinese brand name: 爱必妥®) has been approved by China's NMPA for use in combination with Encorafenib to treat adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have previously received systemic therapy.
The approval of this new indication for cetuximab is based on the results of a randomized, multicenter, global Phase III clinical trial, BEACON CRC, and a bridging study in China, NAUTICAL:
The BEACON CRC study showed that, compared with the current standard of care, the combination of cetuximab (Erbitux®) and encorafenib (BRAFTOVI®) significantly extended overall survival in patients with BRAFV600E-mutant metastatic colorectal cancer and reduced the risk of death by 40%.
The NAUTICAL study demonstrated that Chinese subjects treated with the combination of Erbitux® and BRAFTOVI® had a 45% reduction in the risk of death compared to the control group.
Colorectal cancer is the third most common malignancy globally, with nearly 2 million new cases worldwide each year, and ranks as the second leading cause of cancer-related deaths. Data indicate that approximately 7.8% of metastatic colorectal cancer patients in China carry the BRAFV600E mutation. This mutation activates the MAPK signaling pathway, leading to rapid tumor proliferation and metastasis, and is generally associated with poor patient prognosis and resistance to conventional chemotherapy. The approval of Erbitux® will provide a new treatment option for this patient population.
As of today, cetuximab has been approved for five indications in China, the first four of which have already been included in the National Reimbursement Drug List, substantially benefiting patients with colorectal cancer and head and neck cancer.
Currently, domestically developed biosimilars that have been launched in China include Simcere Pharmaceutical and Mabpharm's Cetuximab Beta Injection. Among those that have completed Phase III clinical trials is APZ001 from Annpo Biotechnology. Products targeting the same pathway/indication include bevacizumab, regorafenib, and fruquintinib. Multiple products are currently in Phase I–III clinical trials, and it is expected that in the next 2–3 years, nearly 10 biosimilars and improved new drugs will enter the market.