The European Medicines Agency (EMA) has accepted a marketing authorization application for Anktiva (nogapendekin alfa inbakicept-pmln) in combination with BCG for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.[1][2] The EMA is now reviewing the application, which, if approved, would apply to all 27 EU states as well as Iceland, Liechtenstein and Norway.[1][2] The claim is supported by data from Cohort A of the QUILT 3.032 trial, where the combination of Anktiva plus BCG achieved a complete response rate of 71% (95% CI: 59.6–80.3) in 100 enrolled patients.[1] Anktiva was first approved by the US FDA on April 22, 2024 for the same indication.[5][7] In the UK, the MHRA approved Anktiva on 4 July 2025 for adults with BCG-unresponsive non-muscle invasive bladder cancer.[4] The drug is administered intravesically via a catheter through the urethra in combination with BCG.[4][7]