J&J begins intravesical drug filing with high hopes
Johnson & Johnson (NYSE: JNJ) has started the submission of an original New Drug Application with the US Food and Drug Administration (FDA) for TAR-200.
The filing seeks approval for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
TAR-200 is an investigational intravesical drug releasing system designed to provide sustained local delivery of gemcitabine into the bladder. It is placed into the bladder by a healthcare professional using a co-packaged urinary placement catheter in an outpatient setting without the need for anesthesia.
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