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杨森制药的厄达替尼是什么药?

Author: Medicalhalo
Release time: 2025-10-19 11:44:20

(Erdafitinib) is the first targeted therapy drug approved by the US FDA for advanced or metastatic urothelial cancer. It regulates cell growth and division by targeting genetic changes in fibroblast growth factor receptor (FGFR) to inhibit tumorigenesis and angiogenesis. Erdafitinib represents the first personalized treatment option for patients with metastatic urothelial cancer who have genetic alterations in FGFR.

Xi'an Janssen Pharmaceutical Co., Ltd. was established in 1985. It is a Sino-foreign joint venture pharmaceutical enterprise mainly engaged in the production and operation of innovative drugs. Since the product was launched in 1989, the company has long been a market leader in the industry and has made outstanding achievements in corporate culture, brand building, customer recognition, human resources, government relations, social impact and other aspects. Erdafitinib of Janssen Pharmaceuticals has been successfully launched overseas, providing certain help for the treatment of patients.

Erdafitinib was approved by the FDA based on a multi-center, open-label single-arm phase II clinical study (BLC2001, NCT02365597 ), this study evaluated the clinical efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma carrying FGFR gene mutations (R248C, S249c, G370c, Y373C) or/and fusions (FCFR3-TACC3, FGFR3BAIAP2L1, FCFR2-BICC1, FGFR2-CASP7). Enrolled patients have undergone at least first-line chemotherapy, and subjects who have undergone immunotherapy are also allowed to be enrolled.

The results published by ASCO in 2018 showed that after 11 months of follow-up, 21.2% of subjects were still undergoing treatment, the median progression-free survival (PFS) was 5.5 months (95% CI: 4.2 ~ 6.0), and the median overall survival (OS) was 13.8 months (95% CI: 9.8-NE).

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