Non-Muscle Invasive Urothelial Carcinoma

FDA Approves IL-15 Receptor Agonist for BCG-Unresponsive NMIBC
The US Food and Drug Administration (FDA) has granted approval to nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience)—an interleukin-15 receptor agonist—with bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Approval came following results of the QUILT-3.032 trial, a single-arm study of 77 patients with BCG-unresponsive, high-risk NMIBC with CIS with or without Ta/T1 papillary disease who had undergone transurethral resection and went on to receive nogapendekin alfa inbakicept-pmln with BCG followed by maintenance therapy for up to 37 months. ...
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