Johnson & Johnson wins FDA priority review for drug delivery system

Johnson & Johnson (NYSE:JNJ) announced today that the FDA granted priority review to a new drug application (NDA) for its TAR-200.

TAR-200, an intravesical gemcitabine-releasing system, treats 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.

A healthcare professional places TAR-200 into the bladder using a co-packaged urinary placement catheter. The procedure takes place in an outpatient setting in less than five minutes and requires no general anesthesia or further monitoring.

“TAR-200 represents an innovation in drug delivery that has not been seen in decades,” said J&J Innovative Medicine Global Therapeutic Area Head, Oncology, Dr. Yusri Elsayed. “The FDA priority review for TAR-200 underscores our mission to fundamentally change the way urologists treat certain types of bladder cancer.”

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