Healthcare products company Johnson & Johnson (J&J) (NYSE:JNJ) announced on Wednesday that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for TAR-200 for the treatment of BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
The FDA is reviewing the application through its Real-Time Oncology Review (RTOR) programme for faster approval.
TAR-200 is the first and only intravesical drug releasing system for this condition and offers an alternative to radical cystectomy, a surgery that removes the entire bladder.
Clinical data from the Phase 2b SunRISe-1 study showed an 83.5% complete response rate with high durability.
TAR-200 is administered in an outpatient setting and has a low rate of severe side effects.
The FDA granted Breakthrough Therapy Designation to TAR-200 in December 2023.
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