厄达替尼是什么药？

What kind of medicine is erdafitinib? is an experimental, once-daily, oral, pan-FGFR tyrosine kinase inhibitor. FGFRs are a family of receptor tyrosine kinases that can be activated by genetic changes in various types of tumors. These genetic changes can lead to the upregulation of EGFR expression in tumor cells and participate in tumor cell proliferation, tumor angiogenesis, and tumor cell survival.

In March 2018, the U.S. Food and Drug Administration (FDA) granted Janssen’s drug erdafitinib Breakthrough Therapy Designation for the treatment of adult patients with locally advanced or metastatic bladder cancer. These tumors have specific genetic mutations called FGFR3 or FGFR2, and the disease progresses despite platinum-based chemotherapy.

The BLC2001 study is a multi-center, open-label, single-arm phase II clinical trial that evaluated the efficacy of erdafitinib in 87 patients with urothelial carcinoma. The median age was 67 years, 79% were male, 74% were white, 92% had a PS score of 0-1, and 66% of the patients had metastatic lesions. 97% of the patients had received at least one platinum-containing chemotherapy, and 3 patients had only received neoadjuvant chemotherapy or adjuvant chemotherapy. 24% of patients had received PD-1/L1 immunotherapy.

The complete response rate was 2.3%, the partial response rate was 29.9%, the total effective rate was 32.2%, and the median effective duration was 5.4 months.

All enrolled patients carried at least one FGFR2/3 mutation or fusion, such as FGFR3 mutations (R248C, S249C, G370C and Y373C), FGFR2 fusions (FGFR2-BICC1 and FGFR2-CASP7) and FGFR3 fusions (FGFR3-TACC3 and FGFR3-BAIAP2L1).

For FGFR3 mutations (n=64), the overall response rate was 40.6%; for FGFR3 fusions (n=18), the overall response rate of erdafitinib was 11.1%; for FGFR2 fusions (n=6), the overall response rate of erdafitinib was 0%.

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.

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