The U.S. Food and Drug Administration approved Johnson & Johnson’s drug-device combination system, Inlexzo, for patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ. The intravesical gemcitabine-releasing system offers a new option to avoid radical bladder removal surgeries for patients who have failed first-line immunotherapy. Clinical trials demonstrated tumor elimination in 82% of patients, with half maintaining response for at least one year.