J&J Seeks FDA Nod for Non-Muscle Invasive Bladder Cancer Drug

Johnson & Johnson (JNJ) has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational drug-device combination to treat certain patients with non-muscle invasive bladder cancer (NMIBC).The J&J filing seeks the FDA’s nod for TAR-200 as a single agent to treat patients with BCG-unresponsive, high-risk NMIBC with carcinoma in-situ (CIS), with or without papillary tumors. If approved, TAR-200 will be the first intravesical drug-releasing system in the given indication.The FDA ...