The Priority Review

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BCG-unresponsive NMIBC

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  1. Approvals

    FDA approves expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive NMIBC

    On October 14, 2026, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva) with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer, adding high-grade papillary-only tumors to the prior indication for carcinoma in situ. The approval is based on efficacy data from Cohort A of QUILT-3.032, which showed a 62% complete response rate (95% CI: 51, 73).