Is Erdafitinib/Bocco the latest new anti-tumor drug in China?

Erdafitinib (Erdafitinib), as an FGFR-targeting drug, has attracted much attention in the global treatment of urothelial cancer (bladder cancer). In January 2025, the National Food and Drug Administration officially approved its domestic marketing under the trade name "Boke" for the treatment of patients with locally advanced or metastatic urothelial cancer who are susceptible to FGFR3 gene changes and have progressed after systemic therapy. Judging from the time point, it is indeed one of the new anti-tumor drugs approved in China in recent years, and its target is relatively novel, so it is representative in the domestic medical community.

The specifications currently on the market in China include 5mg 28 tablets, 3mg 56 tablets, 4mg*28 tablets, etc., but they have not yet been included in the national medical insurance directory, resulting in certain restrictions on clinical accessibility. Due to the short time to market and the gradual improvement of supply channels, patients will indeed face difficulty in purchasing drugs in some areas. Compared with PD-1 or conventional targeted drugs, FGFR-targeted drugs are less popular in China and therefore are typical representatives of “new categories and new targets”.

From an international trend, the United States FDA allows screening of applicable patients through BALVERSA’s companion diagnostic tests (such as FGFR3 specific changes), which is also an important prerequisite for FGFR-targeted therapy. In the future, a matching testing system will be gradually established in China to enable patients to accurately select treatment plans based on genetic characteristics.

Although erdafitinib is a “newly approved drug”, it is not the “latest and only” in the market sense. The global class of similar FGFR-targeted drugs is constantly expanding, but erdafitinib is still one of the most mature and well-researched representative drugs. The launch in China means that FGFR pathway therapy has officially entered routine clinical options, providing a new path for mUC patients with previously limited treatment.

Therefore, from the perspective of clinical value and time point, erdafitinib is indeed one of the important new drugs approved in China in recent years, but its real significance lies in providing a new direction for gene-targeted therapy, rather than simply "the latest on the market."

Reference materials：https://www.balversa.com/