胆管癌治疗新药培美替尼在中国批准上市了吗？

Pemetinib (also known as pemetinib, English trade name: pemazyre) is the world's first targeted drug for cholangiocarcinoma. On April 17, 2020, the U.S. FDA accelerated approval of Incyte's pemetinib Pemazyre for the treatment of previously treated patients with locally advanced or metastatic cholangiocarcinoma carrying fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement. The approval time was one and a half months ahead of the scheduled approval date of May 30. This is also the world's first targeted therapy for cholangiocarcinoma. Data shows that the objective response rate in treating patients with FGFR2 fusion/rearrangement exceeds 30%, the disease control rate exceeds 80%, and the effect is rapid and long-lasting.

Has the new drug pemetinib for the treatment of cholangiocarcinoma been approved for marketing in China? Pemetinib is a new anti-tumor drug and has just been launched in the United States for less than a year. It has not yet been launched in China, and patients cannot buy the drug in China. However, there are also progress events for pemetinib in China: On March 4, 2020, Innovent Biologics completed the first administration of pemetinib in China, which became an important milestone for pemetinib to enter the Chinese market; pemetinib is in phase II clinical research in China to evaluate the efficacy and safety of subjects with cholangiocarcinoma.

Cholangiocarcinoma is a relatively common hepatobiliary tumor. Most patients with cholangiocarcinoma are diagnosed at an advanced stage and cannot be cured by surgery. The standard initial treatment is a chemotherapy regimen of cisplatin combined with gemcitabine. The ORR is 15~26%, and drug resistance often occurs. Now the advent of pemetinib has brought a new dawn to the treatment of patients with advanced cholangiocarcinoma! About 9%-14% of patients with cholangiocarcinoma have FGFR2 fusion genotypes. Pemetinib prevents the growth and spread of tumor cells by blocking FGFR2 in tumor cells. Therefore, if patients with cholangiocarcinoma want to receive treatment, they first need to determine whether the FGFR2 gene has been fused or rearranged.

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.