A phase 3, randomized study evaluating the efficacy and safety of TAR-210 Erdafitinib intravesical delivery system versus single agent intravesical chemotherapy in participants with intermediate-risk non-muscle invasive bladder cancer

INTERVENTION: Group A Participants will receive TAR‐210 (500 mg erdafitinib intravesical drug delivery system) every 12 weeks (+/‐ 1 week window) over a treatment duration of approximately 1 year. TAR‐210 drug delivery system containing 500 mg Erdafitinib (release rate approximately 3 mg/day) will be administered to the participant intravesically. Group B For participants in Group B, Mitomycin C (MMC) or gemcitabine will be dosed once weekly for 4‐6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year within a minimum dose of 6 treatment cycles. Gemcitabine (2000 mg) or MMC (40 mg) will be administered to the participant intravesically CONDITION: Intermediate‐risk Non‐muscle Invasive Bladder Cancer (IR‐NMIBC) ; Cancer PRIMARY OUTCOME: The primary endpoint for the study is disease‐free survival (DFS). DFS will be measured as the time from randomisation to the date of the first documented recurrence of NMIBC of any grade, disease progression, or death due to any cause, whichever occurs first SECONDARY OUTCOME: 1. Time to next treatment (TTNT). Randomisation to the date of first documented subsequent treatment for bladder cancer.; 2. High grade (HG) recurrence‐free survival (RFS). Randomisation to the date of HG NMIBC or death.; 3. Progression‐free survival (PFS). Randomisation to the date of disease progression or death.; 4. The rate of diagnostic and therapeutic invasive urological interventions after study treatment.; 5. Safety and tolerability: Frequency/grade of AEs and other measures.; 6. OS. Randomisation to the date of death from any cause.; 7. Proportion of participants with meaningful change in EORTC QLQ‐C30 and EORTC QLQ‐NMIBC24 scores between study treatments.; INCLUSION CRITERIA: 1. Be 18 or more years of age at the time of informed consent. 2. Have a histologically confirmed diagnosis (within 90 days of randomisation) of intermediate‐risk non‐muscle invasive bladder cancer (IR‐NMIBC) with at least one of the protocol‐defined criteria fulfilled. 3. Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumour tissue testing (from transurethral resection of bladder tumour [TURBT] tissue), as determined by central or local testing. 4. Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomised into that arm. 5. Visible papillary disease must be fully resected prior to randomisation and absence of disease must be documented at Screening cystoscopy. The same method for visualisin