Johnson & Johnson Gets FDA OK for Intravesical Drug Delivery Tech

Johnson & Johnson has received U.S. Food and Drug Administration (FDA) approval for Inlexzo (gemcitabine intravesical system), a new approach to treat patients with certain types of bladder cancer.

Inlexzo addresses the need for additional options after unsuccessful BCG therapy and for patients refusing or not eligible for bladder removal surgery. Previously referred to as TAR-200, Inlexzo is indicated to treat adults with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

Inlexzo is the first and only intravesical drug releasing system (iDRS) that provides extended local delivery of a cancer medication into the bladder. It remains in the bladder for three weeks per treatment cycle for up to 14 cycles, J&J said.

It’s placed into the bladder using a co-packaged urinary catheter and stylet to insert it into the bladder. It’s placed in an outpatient setting in a couple of minutes without needing general anesthesia or further monitoring immediately post-insertion in the healthcare provider’s office.

This approval was backed by data from the SunRISe-1 Phase 2b clinical study. 82% of patients with BCG-unresponsive NMIBC treated with Inlexzo achieved a complete response, meaning no signs of cancer were found after treatment. 51% of patients maintained a complete response for at least one year.

“When we acquired this novel therapy in 2019, our ambition was to give patients with bladder cancer a renewed sense of hope and belief,” said Jennifer Taubert, executive VP, worldwide chairman, Innovative Medicine, Johnson & Johnson. “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.”