Results from a Phase 1 study show that Erda-iDRS (TAR-210), a new drug-delivery system placed directly into the bladder, appears to be both safe and effective for patients with FGFR-altered non–muscle-invasive bladder cancer.
In high-risk patients, the treatment kept cancer from coming back for a median of 20 months, with 83% of patients remaining recurrence-free after one year. In intermediate-risk patients, 89% had a complete response at six months, and responses lasted a median of 18 months.
The treatment was generally well tolerated. Most side effects were mild urinary symptoms such as blood in the urine or discomfort while urinating. Only 4.5% of patients experienced more serious side effects. Importantly, no cases of high phosphate levels or eye-related toxicities—common issues with similar drugs given systemically—were reported.
These results support the idea that delivering erdafitinib directly into the bladder can be effective while reducing side effects. Larger Phase 2 and 3 trials are now in progress to confirm these findings.