J&J’s Inlexzo Bladder Cancer Therapy Wins ‘Practice-Changing’ FDA Approval

The FDA has approved Johnson & Johnson's Inlexzo (gemcitabine intravesical system) as a novel therapy for adults with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors45.

Inlexzo is the first and only drug-releasing system offering extended local delivery of gemcitabine directly into the bladder, with each treatment lasting three weeks and up to 14 cycles administered without anesthesia14.

The approval is based on the Phase IIb SunRISe-1 trial, where Inlexzo demonstrated an 82% complete response rate in BCG-unresponsive NMIBC patients51.

J&J acquired the therapy (formerly TAR-200) through the purchase of Taris Biomedical and licensed technology from MIT in 2019; it has received Breakthrough Therapy Designation, Real-Time Oncology Review, and Priority Review314.

Inlexzo fills an urgent need for patients who have failed standard BCG therapy and are seeking bladder-sparing alternatives to radical cystectomy (bladder removal surgery)24.

This therapy positions J&J to challenge existing NMIBC treatments by ImmunityBio, Ferring, and Merck, potentially forecasting peak sales over $5 billion3.

Sources:

1. https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated

2. https://www.ainvest.com/news/johnson-johnson-receives-fda-approval-gemcitabine-bladder-cancer-treatment-2509/

3. https://www.oncologypipeline.com/apexonco/jjs-bladder-hope-gets-its-first-approval

4. https://www.bioworld.com/articles/724080-j-and-j-wins-us-fda-approval-of-inlexzo-for-bladder-cancer

5. https://www.pharmexec.com/view/fda-approves-j-j-inlexzo-bacillus-calmette-gu-rin-unresponsive-non-muscle-invasive-bladder-cancer