Onco-Summaries: Daily Oncology Updates at a Glance

09/09/2025

Johnson & Johnson's INLEXZO received US FDA approval for NMIBC (Ref)

The US FDA approved Johnson & Johnson's INLEXZO™ (TAR-200; gemcitabine intravesical system) for the treatment of adult patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

• The approval is based on results from the Phase 2b SunRISe-1/NCT04640623 trial

  
  

• Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson: “When we acquired this novel therapy in 2019, our ambition was to give patients with bladder cancer a renewed sense of hope and belief. In an area that has seen little progress for more than 40 years, INLEXZO delivers a first-of-its-kind breakthrough innovation with a bright future ahead.”