Is erdafitinib (Bocco) considered safe and tolerable after three years of long-term use with normal liver function?

Erdafitinib is an oral FGFR (fibroblast growth factor receptor) inhibitor, mainly used to treat advanced or metastatic bladder cancer and other solid tumors carrying FGFR gene mutations or rearrangements. It blocks tumor cell proliferation and angiogenesis by inhibiting the FGFR signaling pathway, thereby delaying disease progression. Common adverse reactions of erdafitinib in clinical use include hyperphosphatemia, stomatitis, abnormal vision, fatigue, and abnormal liver function. Therefore, during long-term medication, liver function monitoring is considered a key indicator for safety assessment.

If the patient's liver function continues to be normal during three years of long-term use, it means that the liver metabolism is well tolerated at this dose and no significant drug-related liver damage occurs. Usually in clinical trials of erdafitinib, liver function abnormalities are mostly reversible mild to moderate increases, including increases in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST), which can be recovered when the dose is adjusted or the drug is temporarily discontinued. Maintaining normal liver function for three years indicates that the patient has good long-term tolerability (long-term tolerability) and no cumulative liver toxicity occurred during treatment.

However, although liver function indicators are normal, this does not mean that other risks are completely absent. Long-term use of erdafitinib still requires attention to other systemic adverse reactions, such as hyperphosphatemia, eye problems, and cardiovascular events. In addition, patients' underlying diseases, concomitant medications, and lifestyle factors may also affect long-term safety. Therefore, in clinical practice, although normal liver function is an important safety signal, regular comprehensive follow-up, including hematology, renal function, and ophthalmology examinations, is required to ensure systemic tolerance.

Overall, the liver function of erdafitinib was normal during three years of long-term use, which can be regarded as well tolerated by the liver and is an important indicator of safe tolerance. This provides a reference for long-term maintenance treatment and also emphasizes the importance of individualized monitoring. As patients continue treatment, they should follow the follow-up plan of professional physicians and dynamically evaluate the safety of each system to maintain long-term efficacy and maximize treatment benefits.

Reference materials:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8449990/