Johnson & Johnson announced it has initiated the submission of an original New Drug Application with the U.S. FDA for TAR-200 for the treatment of patients with Bacillus Calmette-Guerin-unresponsive high-risk non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors. This submission is being reviewed by the FDA through the Real-Time Oncology Review program, which allows the FDA to review data before the complete application is formally submitted and helps ensure treatments are available for patients as soon as possible.
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