FDA expands bladder cancer therapy approval

The expansion offers another treatment option for patients with high-grade tumors following BCG failure.

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The FDA expanded nogapendekinalfainbakicept-pmln plus BCG approval to adults with BCG-unresponsive, high-grade papillary-only NMIBC.
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The October 14, 2026, expansion extends the combination’s prior indication for BCG-unresponsive NMIBC with CIS, with or without papillary tumors.
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The FDA extrapolated efficacy evidence from patients with CIS based on clinical and nonclinical similarities; no separate efficacy trial in papillary-only disease supported the expansion.
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In the 77-patient QUILT-3.032 Cohort A trial, the complete response rate was 62%; among responders, 58% maintained response for at least 12 months and 40% for at least 24 months.
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The prescribing information warns that delaying cystectomy may lead to lethal metastatic bladder cancer and advises discontinuation for persistent disease, recurrence, progression, or unacceptable tox

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