On February 7, 2025,Sichuan Kelun-Biotech Biopharmaceutical announced the approval of its Cetuximab N01 Injection by the National Medical Products Administration for the treatment of metastatic colorectal cancer (mCRC) in China.
The approval is based on a large-scale phase III clinical study showing the drug’s equivalence in efficacy and safety to existing treatments, potentially increasing treatment accessibility for mCRC in China where the incidence and mortality rates are rising.
The study included a total of 688 patients, and the results showed that the combination chemotherapy regimen of cetuximab N01 was clinically equivalent in objective response rate (ORR) compared to cetuximab injection (Erbitux) combined chemotherapy (ORR). The objective response rate (ORR) of cetuximab N01 and cetuximab injection (Erbitux) were 71.0% and 77.5%, respectively. There was no clinically or statistically significant difference in response duration (DoR) and progression free survival (PFS) between cetuximab N01 and cetuximab injection (Erbitux), with median progression free survival of 10.9 months and 10.8 months, respectively.
In terms of safety, this phase III large-scale head to head controlled clinical trial fully confirms that the combination chemotherapy regimen of cetuximab N01 is comparable in safety, tolerability, and immunogenicity compared to cetuximab injection (Erbitux) combined chemotherapy.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
Email：myimmnet@163.com
References
1.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250207150842162.html
2.Wu CC, Hsu CW, Hsieh MC, et al. Optimal Sequence and Second-Line Systemic Treatment of Patients with RAS Wild-Type Metastatic Colorectal Cancer: A Meta-Analysis. J Clin Med. 2021 Nov 4;10(21):5166.
Post time: Feb-13-2025