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NEWS

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 tumorsApproval 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-responseInlexzo is…
September 10, 2025

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NEWS

The US FDA Grants Priority Review to Johnson & Johnson’s TAR-200 for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Shots:The US FDA has granted priority review to NDA of TAR-200 for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS &/or papillary tumorsNDA was supported by the P-IIb (SunRISe-1) trial, assessing TAR-200 in pts ineligible or opting out of radical cystectomy that showed an 82.4% CR rate & 52.9% remained cancer-free for at…
July 18, 2025

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