Kameleon007 Johnson & Johnson (NYSE:JNJ) on Friday received full FDA approval for its bladder cancer therapy erdafitinib (Balversa) as a late-line option for certain patients with urothelial carcinoma. Accordingly, the once-daily oral FGFR kinase inhibitor will be indicated in the U.S. after systemic therapy for adults with urothelial carcinoma harboring FGFR3 alterations, as proven by an FDA-approved test.

Kameleon007强生公司（纽约证券交易所代码：JNJ）于周五获得美国食品和药物管理局（FDA）的全面批准，将其膀胱癌疗法erdafitinib（Balversa）作为某些尿路上皮癌患者的晚期选择。因此，如FDA批准的测试所证明的，在对患有FGFR3改变的尿路上皮癌的成年人进行全身治疗后，每天一次的口服FGFR激酶抑制剂将在美国使用。

In 2019, the FDA granted accelerated approval for erdafitinib as a treatment for adults with locally advanced or metastatic urothelial carcinoma with FGFR3 or FGFR2 genetic alterations after at least one line of platinum-containing chemotherapy. In August, JNJ's Janssen unit submitted a supplemental new drug application ((sNDA)) seeking its full approval based on data from its Phase 3 THOR trial, which had met the primary endpoint of overall survival.

2019年，FDA加速批准厄达非尼治疗成人局部晚期或转移性尿路上皮癌伴FGFR3或FGFR2基因改变，至少一行含铂化疗后。8月，JNJ的杨森单位提交了一份补充新药申请（（sNDA）），根据其3期THOR试验的数据寻求全面批准，该试验已达到总体生存的主要终点。

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