胆管癌新药培美替尼药品说明书

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.

The indications of the new drug pemetinib for cholangiocarcinoma include: (1) Cholangiocarcinoma that has metastasized (spread to other parts of the body) or is locally advanced and cannot be treated by surgery. (2) For the treatment of adults with diseases involving FGFR2 gene fusions or other changes in the FGFR2 gene structure.

Cholangiocarcinoma refers to a malignant tumor originating from the extrahepatic bile duct, including the bile duct from the portal area to the lower end of the common bile duct. Clinical treatments such as surgery, radiotherapy, chemotherapy, targeted therapy, and immunotherapy can be used, but the prognosis is poor. Cholangiocarcinoma has a low incidence rate but a high degree of malignancy. Clinical trials have proven that pemetinib is effective in the treatment of cholangiocarcinoma. Pemetinib enrolled 107 patients who had received previous treatment and carried FGFR2 gene fusion or rearrangement. Pemetinib was administered orally at 13.5 mg once daily for a 21-day cycle until imaging disease progression or intolerable toxicity occurred. The trial results showed that the overall response rate (ORR) of pemetinib reached 36%, of which 2.8% of patients had complete response and 33% of patients had partial response. The median progression-free survival (PFS) was 9.2 months and the median overall survival (OS) was 15.8 months.

The recommended dose of pemetinib is 13.5 mg orally daily for 1 day for 21 days, followed by 7 days off, in a 21-day cycle. Continue treatment until disease progression or unacceptable toxicity. If the patient misses a dose by 4 hours or more, or experiences vomiting, restart the medication with the next scheduled dose.

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.