The European Medicines Agency (EMA) has recommended conditional marketing authorisation for Anktiva (nogapendecin alfa inbakicept) for the treatment of adult patients with non-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours, who are unresponsive to BCG therapy.[1][2][3] Anktiva is an interleukin-15 (IL-15) receptor agonist that promotes immune response by stimulating CD4+ and CD8+ T cells and NK cells.[1][5] It is administered as a concentrated solution of 400 μg directly into the bladder in combination with BCG, once weekly for 6 weeks as induction therapy and then as maintenance therapy.[1][2] Efficacy was demonstrated in a single-arm, open-label, phase 2/3 study with 100 patients, achieving a complete response rate of 71% (95% CI: 61.1-79.6) and a median duration of complete response of 26.6 months (95% CI: 13.0-49.9).[1][3] The drug is available under the ATC code L03AC03.[1] The EMA opinion will allow an earlier approach to treatment, where the alternative remains surgical removal of the bladder.[7]