The FDA approved Johnson & Johnson's drug-device combination, Inlexzo (formerly TAR-200), for treating Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ. Inlexzo delivers gemcitabine chemotherapy directly into the bladder via an implantable device, providing a less invasive option than bladder removal. Clinical trials showed an 82% tumor elimination rate and 51% one-year response durability. The treatment offers a new option for patients unresponsive to immunotherapy.