What is erdafitinib and how effective is it?

Erdafitinib (erdafitinib) is used to treat certain types of urothelial cancer (cancer in the lining of the bladder and other parts of the urethra) that have spread to nearby tissue or other parts of the body, cannot be removed with surgery, and get worse during or after treatment with other chemotherapy drugs. Erdafitinib belongs to the kinase inhibitor class of drugs. It works by blocking the activity of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

This indication is approved under accelerated approval based on tumor response rate. Continued approval for this indication may be dependent on verification and description of clinical benefit in confirmatory trials.

Accelerated approval of erdafitinib is based on results from a Phase 2 multicenter, open-label, single-arm study of 87 patients with disease that had progressed during or after at least one line of chemotherapy and who had at least one of the following genetic alterations in the FGFR3 gene Mutations (R248C, S249C, G370C, Y373C) or FGFR gene fusions (FGFR3-TACC3, FGFR3-BAIAP2L1, FGFR2-BICC1, FGFR2-CASP7) were determined by clinical trial assays conducted by a central laboratory. The results showed that the objective response rate (ORR) assessed by the Blinded Independent Review Committee (BIRC) was 32.2%. Responders included patients who had previously failed to respond to anti-PD-L1/PD-1 therapy. In the trial, ORR was defined as the percentage of patients with measurable disease who achieved a complete response (CR) [2.3%] or a partial response (PR) [29.9%] to treatment based on investigator assessment using RECIST v1.1 criteria. The results also showed that the median duration of response (DoR) in patients treated with erdafitinib was 5.4 months. There were no confirmed responses to erdafitinib in the FGFR2 fusion patient population (n=6).

Since erdafitinib is not yet available in China, patients need to purchase it from abroad or contact regular overseas medical consulting companies. As far as we know, the original drug of erdafitinib in Hong Kong is 4mg*14 tablets, and the price exceeds 20,000 yuan. In addition, there are generic versions of erdafitinib available on the market. For example, the version marketed in Bangladesh is available in three specifications: 3mg, 4mg and 5mg. The price of 28 tablets of the 4mg specification is about 1,000 yuan. If you want to get more information about generic drugs of erdafitinib, please consult a regular overseas medical consulting company.