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FDA Approves Inlexzo for Bladder Cancer
Inlexzo offers a bladder-sparing treatment option with 82% complete response rate and 51% maintaining response for a year, addressing a critical need for BCG-unresponsive bladder cancer patients.
- The U.S. FDA approved Inlexzo, a gemcitabine intravesical system, for treating adult patients with BCG-unresponsive non-muscle-invasive bladder cancer.
- This approval followed the SunRISe-1 single-arm, phase 2b clinical trial that studied patients who did not respond to traditional BCG therapy and sought bladder preservation.
- Inlexzo delivers extended local drug release, achieved an 82% complete response rate, and maintained durability with 51% of responders preserved after one year.
- Johnson & Johnson, who acquired the therapy in 2019, highlighted its potential to change treatment, while experts noted it is well tolerated and offers clinically meaningful results.
- The approval introduces a bladder-sparing option for patients at risk of bladder removal, indicating a possible shift in managing this cancer subtype with improved patient guidance.
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Pretzel-Shaped Therapy Wins FDA Approval for Early Bladder Cancer
(MedPage Today) -- The FDA approved a gemcitabine intravesical system (Inlexzo) for adults with non-muscle-invasive bladder cancer (NMIBC), the agency announced on Tuesday. The indication for the chemotherapy-containing system stipulates use in...
·New York, United States
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Coverage Details
Total News Sources26
Leaning Left3Leaning Right2Center6Last UpdatedBias Distribution55% Center
Bias Distribution
- 55% of the sources are Center
55% Center
L 27%
C 55%
R 18%
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