Posted by Michael Wonder on 22 Apr 2024
FDA approves nogapendekin alfa inbakicept-pmln for BCG unresponsive non-muscle invasive bladder cancer
22 April 2024 - Today, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience) 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 tumours.
Efficacy was evaluated in QUILT-3.032, a single-arm, multi-centre trial of 77 patients with BCG unresponsive, high risk NMIBC with CIS with or without Ta/T1 papillary disease following transurethral resection.
