Story perspectives

Johnson & Johnson’s INLEXZO™ Approved for Bladder Cancer Treatment

9/10/2025

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Summary

Story summary

Johnson & Johnson's INLEXZO™ received FDA approval on September 9, 2025, for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
This treatment offers an alternative for patients ineligible for or refusing radical cystectomy, administering medication directly into the bladder.
The SunRISe-1 trial demonstrated an 82% complete response rate, with 51% maintaining it for over a year.
Common side effects include urinary frequency and infections.
J&J plans to support patients through its withMe program.

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Story summary

Johnson & Johnson's INLEXZO™ received FDA approval on September 9, 2025, for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
This treatment offers an alternative for patients ineligible for or refusing radical cystectomy, administering medication directly into the bladder.
The SunRISe-1 trial demonstrated an 82% complete response rate, with 51% maintaining it for over a year.
Common side effects include urinary frequency and infections.
J&J plans to support patients through its withMe program.