Is Erdafitinib on the market?

In April 2019, the U.S. Food and Drug Administration (FDA) officially approved Erdafitinib (Erdafitinib) for marketing , a treatment for adult patients with locally advanced or metastatic bladder cancer that has a susceptibility genetic alteration called FGFR3 or FGFR2 that has progressed during or after prior platinum-containing chemotherapy. Patients should be selected for erdafitinib treatment using FDA-approved companion diagnostic equipment.

The efficacy of erdafitinib was studied in a clinical trial that included 87 patients with locally advanced or metastatic cancer whose FGFR3 or FGFR2 gene alterations had progressed after chemotherapy. The overall response rate for these patients was 32.2%, with 2.3% of patients having a complete response and nearly 30% of patients having a partial response. Responses lasted about five and a half months on average, and patients who had previously failed to respond to anti-PD-L1/PD-1 therapy responded to erdafitinib. Common side effects are mouth sores, feeling tired, changes in kidney function, diarrhea, dry mouth, nails that separate from the bed or poorly formed nails, changes in liver function, decreased appetite, changes in taste, anemia, dry skin, dry eyes, and hair loss.

The original version of erdafitinib has not yet been launched in China, so it cannot be covered by medical insurance. The original version of erdafitinib currently sold in Hong Kong may cost more than 20,000 yuan per box of specifications 4mg*14 tablets (the price may fluctuate due to exchange rates). Cheaper erdafitinib generic drugs produced by other pharmaceutical factories are also sold overseas. The pharmaceutical ingredients are basically the same as those of the original drug. For example, the price of 4mg*60 tablets produced by a Bangladeshi pharmaceutical factory may be more than 3,000 yuan per box (the price may fluctuate due to exchange rates).