先行先试！近日，胆管癌新药英菲格拉替尼在海南开出首张处方

Cholangiocarcinoma is a common malignant tumor originating in the liver. Currently, the treatment and prognosis of cholangiocarcinoma are average, and the survival rate is low. The field of precise targeted treatment of cholangiocarcinoma has always been blank, and there is a lack of targeted drugs for precise treatment. Infigratinib is an effective drug for the treatment of cholangiocarcinoma with FGFR gene mutations. It is another cholangiocarcinoma-targeted drug that emerged after pemetinib and was approved for marketing in May 2021. Recently, Infigratinib was launched at Boao Super Hospital in Lecheng, Hainan, and its first prescription outside North America was issued. The following will give a comprehensive introduction to Infigratinib, hoping to help everyone.

1. Cholangiocarcinoma and Current Treatment Status

Cholangiocarcinoma, a cancer of the bile ducts in the liver, is a serious and fatal disease. According to statistics, about 72,000 patients are diagnosed in China every year, and about 14% to 17% of cholangiocarcinoma patients have FGFR2. Genetic abnormalities.

Since cholangiocarcinoma is a malignant tumor and its prevalence is high in China, innovative treatments are urgently needed for cholangiocarcinoma patients. Especially for patients with second-line and above cholangiocarcinoma, before the emergence of infigratinib, there were no effective targeted drugs in China.

2. The mechanism of action and efficacy of infigratinib

Infigratinib is a potent, oral, selective, ATP-competitive fibroblast growth factor receptor (FGFR) kinase inhibitor. 1, 2 and 3 have the highest affinity. Infigratinib blocks downstream signaling cascades by selectively binding and inhibiting FGFR activity, reducing cancer cell proliferation and inducing tumor cell death.

Safety and efficacy:

At the 2020 ASCO meeting, a clinical study on infigratinib was released. This is a phase 2, multi-center, single-arm trial clinical study designed to study the efficacy of infigratinib as a third-line or above treatment for patients with FGFR2 fusion-positive cholangiocarcinoma.

The trial results showed that in the case of second-line treatment, the median progression-free survival (PFS) of patients was 4.63 months; the median progression-free survival (PFS) of patients who received third-line or above treatment with infigratinib was 6.77 months. In terms of objective response rate (ORR), in patients who received third-line or above treatment, the ORR of infigratinib was 21.6%.

In patients with cholangiocarcinoma with FGFR2 fusion, infigratinib in third-line and above-line treatment has greater benefit in terms of progression-free survival (PFS) and objective response rate (ORR) compared with second-line standard chemotherapy regimen.

3. In December 2021, Infigratinib was launched in Hainan, and the first prescription in China was issued

In December 2021, infigratinib was approved by the Hainan Provincial Health Commission and the Hainan Provincial Food and Drug Administration for the treatment of patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma who carry FGFR2 gene fusions or rearrangements.

The first patient in China approved for the licensed use of Infigratinib received treatment at Boao Super Hospital in Lecheng, Hainan. This was also the first prescription for Infigratinib outside North America only 6 months after its launch.

4. Access channels for Infigratinib

At present, infigratinib has not yet been launched in China. Patients need to go to Hainan Boao Super Hospital to get a prescription. Due to the epidemic, it is not very convenient to go to Hainan for medical treatment. Therefore, it is a good way to obtain it through formal overseas medical service organizations (medical companion tours).

5. Conclusion

The precise treatment of second-line and above cholangiocarcinoma has always been a major problem in the clinical field, and the emergence of infigratinib has effectively filled the gap in this field. Currently, infigratinib is being studied in the field of oncology and used to treat tumors with a variety of genetic mutations. In the future, infigratinib will be developed for more new indications and benefit more cancer patients.