FDA approves first-of-a-kind intravesical drug delivery system for bladder cancer

Recent authorisation of Inlexzo ™ (gemcitabine intravesical system) by the US Food and Drug Administration (FDA) offers certain patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) a novel treatment alternative.

It is indicated for NMIBC patients with carcinoma in situ (CIS), with or without papillary tumours, and for individuals who have limited options prior to possible bladder removal.

Inlexzo (previously known as TAR-200), remains in the bladder for three weeks per treatment cycle for up to 14 cycles.

“I see many patients that ultimately become BCG-unresponsive and often face life-altering bladder removal. These patients now may be ideal candidates for newly approved Inlexzo,” said Dr Sia Daneshmand, TAR-200 SunRISe-1 principal investigator, and Professor of Urology and Director of Urologic Oncology at University of Southern California, US. “In my experience, Inlexzo is well-tolerated and delivers clinically meaningful results. This will change the way we treat appropriate patients that haven’t responded to traditional therapy.”

What led to the FDA’s approval of Inlexzo?

Clinical data demonstrating the drug’s high response rate supported the FDA’s decision. In the SunRISe-1 Phase IIb study, 82 percent of patients attained complete response without the need for reinduction, according to Johnson & Johnson. Of these patients, 51 percent sustained this response for at least 12 months.

This data for the company’s drug delivery system adds to positive findings presented at the European Society for Medical Oncology (ESMO) Congress in 2023.

Commenting on the FDA’s approval, Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson remarked: “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.”

The safety and efficacy of Inlexzo is being evaluated in clinical trials in patients with MIBC in SunRISe-4, and NMIBC in SunRISe-1, SunRISe-3, and SunRISe-5.