NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) Wednesday said it has initiated the submission of new drug application or NDA to Food and Drug Administration (FDA) for TAR-200 to treat patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
This submission is being reviewed by the FDA through the Real-Time Oncology Review (RTOR) 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.
The submission was supported by data from the Phase 2b SunRISe-1 registration study, which showed a complete response (CR) rate of 83.5 percent in patients treated with TAR-200.
TAR-200 is an investigational intravesical drug releasing system designed to provide sustained local delivery of chemotherapy drug gemcitabine into the bladder.
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