Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ [CIS], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 milligrams (mg) once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.

Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy and who either refused or were not eligible for cystectomy received the investigator's choice of treatment: either gemcitabine intravesical instillation (4 induction doses: 2000 mg once weekly on Days 1, 8, 15 and 22 of Cycle 1 followed by monthly maintenance dose on Day 1 of Cycle 2 to 7, each cycle of 28 days) or either mitomycin C (MMC) or hyperthermic MMC as an intravesical instillation at the dose of 40 mg/40 milliliter (mL). Additional doses of induction or maintenance were allowed per local standard of care. The choice of drug was determined by the investigator and treatment continued until its completion, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). Participants with locally confirmed high-risk recurrence on Investigator's Choice were offered an option to crossover treatment with erdafitinib until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.

Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.

Participants with intermediate-risk NMIBC presenting as papillary disease only (low grade [Grade 1- Grade 2], Ta or T1, with no previous CIS) received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.

Total of all reporting groups

Participants with high-risk non-muscle-invasive bladder cancer (NMIBC) presenting as papillary tumor only (carcinoma in situ [CIS], absent), with disease recurrence after bacillus Calmette- Guerin (BCG) therapy and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 milligrams (mg) once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.

Participants with high-risk NMIBC presenting as papillary tumor only (CIS, absent), with disease recurrence after BCG therapy and who either refused or were not eligible for cystectomy received the investigator's choice of treatment: either gemcitabine intravesical instillation (4 induction doses: 2000 mg once weekly on Days 1, 8, 15 and 22 of Cycle 1 followed by monthly maintenance dose on Day 1 of Cycle 2 to 7, each cycle of 28 days) or either mitomycin C (MMC) or hyperthermic MMC as an intravesical instillation at the dose of 40 mg/40 milliliter (mL). Additional doses of induction or maintenance were allowed per local standard of care. The choice of drug was determined by the investigator and treatment continued until its completion, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). Participants with locally confirmed high-risk recurrence on Investigator's Choice were offered an option to crossover treatment with erdafitinib until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.

Participants in Cohort 1 who initially received investigator's choice of treatment with locally confirmed high-risk recurrence on investigator's choice were offered an option to crossover at crossover screening visit and received erdafitinib tablets orally, at a dose of 6 mg once daily starting from crossover Cycle 1 Day 1 (Month 12) up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years) until protocol amendment 6 (dated 13 July 2023). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.

Participants with high-risk, BCG- unresponsive NMIBC presenting as CIS with or without concurrent papillary tumor and who either refused or were not eligible for cystectomy received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.

Participants with intermediate-risk NMIBC presenting as papillary disease only (low grade [Grade 1- Grade 2], Ta or T1, with no previous CIS) received erdafitinib tablets orally, at a dose of 6 mg once daily starting from Day 1 through Day 28 in each subsequent 28-day cycle starting from Day 1 of Cycle 1 up to disease recurrence or progression, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurred first (up to 2 years). With the implementation of Protocol Amendment 6 (dated 13 July 2023), participants who benefited from the study drug, as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.