TAR-200 device approved by the US FDA for non-muscle invasive bladder cancer

The US FDA has approved Inlexzo™ (gemcitabine intravesical system), a novel chemotherapy-releasing device for treating specific types of bladder cancer.

The TAR-200 device has been approved for adult patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. This innovative system delivers chemotherapy directly to the bladder, providing a targeted treatment approach and allowing for bladder removal surgery to be avoided.

The FDA approval follows promising data from the SunRISe-1 clinical trial, which demonstrated that 80% of patients experienced complete tumor elimination and 51% of these patients maintained a complete response for at least 1 year.

Slow–release gemcitabine device targets bladder cancer more effectively

Read further details of the SunRISe-1 trial and the TAR-200 device in this Oncology Central news piece.

Johnson & Johnson is currently developing TAR-210, a next-generation version of the device designed to extend treatment duration from the current 3 weeks to 3 months. This advancement could further improve patient outcomes and treatment convenience.

“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,” commented Johnson & Johnson spokesperson Jennifer Taubert.