The US FDA Approves Johnson & Johnson’s Inlexzo for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)
Shots:
- The US FDA has approved Inlexzo for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS &/or papillary tumors
- Approval was based on the P-IIb (SunRISe-1) trial, assessing Inlexzo in pts ineligible or opting out of radical cystectomy, which showed an 82% CR rate, with 51% remaining cancer-free for at least 1yr. post-response
- Inlexzo is an intravesical drug-releasing system that is responsible for the sustained release of gemcitabine into the bladder & is also being evaluated in SunRISe-3 & SunRISe-5 for NMIBC as well as SunRISe-4 for MIBC
Ref: Johnson & Johnson | Image: Johnson & Johnson | Press Release
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