Skip to content Skip to footer

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

Related News:- Johnson & Johnson’s Darzalex Secures the EC’s Approval for High-Risk Smouldering Multiple Myeloma

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com