Curie Brief
Turn on cookies to sign in
Signing in saves your progress to your Curie account. We can only do that with cookies on — turn them on to continue.
News
The FDA has expanded the approval of nogapendekin alfa inbakicept (Anktiva) combined with BCG to include adults with BCG-unresponsive, high-grade, papillary-only non–muscle-invasive bladder cancer (NMIBC). This builds on its 2024 approval for NMIBC with carcinoma in situ. In the pivotal trial, 62% of patients achieved a complete response, with more than half maintaining it for at least 12 months.
The FDA has expanded the approved indication for nogapendekin alfa inbakicept (Anktiva) in combination with BCG, now covering adult patients with BCG-unresponsive, high-grade, papillary-only non–muscle-invasive bladder cancer (NMIBC). This builds on the drug's 2024 approval, which covered NMIBC with carcinoma in situ (CIS) with or without papillary tumors.
The new approval was supported by data from cohort A of the phase 2/3 QUILT-3.032 trial. The FDA extrapolated efficacy from the CIS cohort to the papillary-only population based on overlapping clinical and nonclinical features between the two disease subtypes. The approval came after a winding regulatory path that included an initial refusal-to-file letter and a resubmission with additional long-term data.
By the Numbers:
Why it matters: For patients with BCG-unresponsive NMIBC — a notoriously difficult-to-treat population — this expanded approval offers a meaningful new option that may help delay or avoid radical cystectomy, improving quality of life outcomes.
