FDA Approves J&J's Inlexzo for Bladder Cancer Patients

The U.S. Food and Drug Administration (FDA) has approved Inlexzo, the first drug delivery system from Johnson & Johnson, for patients with high-risk non-muscle invasive bladder cancer who have failed standard Bacillus Calmette-Guerin (BCG) therapy and do not have the option or desire to have their bladder removed.

Bladder cancer remains one of the most prevalent cancers diagnosed, with approximately 75% being non-muscle invasive. Up to this point, patients who did not respond to BCG had a limited pathway for treatment, usually resulting eventually in having their bladder removed. The Inlexzo approval provides an alternative to the treatment landscape.

"This drug, at ultra low doses for long periods of time ... behaves in a way that not only pushes the disease into remission, but then maintains it through some immune memory," Christopher Cutie, vice president and disease area leader for bladder cancer, at J&J.

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The approval by the FDA was based upon a mid-stage study, which demonstrated that 82% of patients had no evidence of cancer at three months, and 55% had no evidence of cancer at one year. Inlexzo (also called TAR-200) is inserted directly into the bladder and is maintained over a course of three weeks per cycle, allowing for sustained release of the chemotherapy agent gemcitabine. Treatment can continue for up to fourteen cycles of Inlexzo and will not disrupt daily life.

Johnson & Johnson acknowledged that urinary frequency, urinary tract infections, and urinary discomfort were the most frequently reported side effects. Although the therapy is being studied for muscle-invasive bladder cancer also, a late-stage trial was suspended last year in this indication because it did not show better efficacy than chemoradiation.