Bladder cancer treatment device nears FDA approval

A bladder cancer treatment device developed in the lab of the Department of Materials Science and Engineering’s Professor Michael Cima is a step closer to becoming a viable therapy for patients with non-muscle invasive bladder cancer (NMIBC), a condition that can become resistant to standard treatments.

On January 15, Johnson & Johnson announced it submitted an original New Drug Application to the U.S. Food and Drug Administration for TAR-200, a pretzel-shaped device designed to be inserted into the bladder and slowly release medication to treat NMIBC.

“Upon approval, TAR-200 promises to be a meaningful additional treatment option for certain patients with NMIBC, addressing a critical need for people who have had relatively limited therapeutic alternatives,” said Yusri Elsayed, global therapeutic head of oncology at Johnson & Johnson Innovative Medicine.

The FDA application is backed by promising clinical trial results, which show an 83.5% complete response rate—the percentage of patients whose cancer has disappeared after treatment.

The device traces its roots back to the mid-2000s, when Cima and then graduate student Heejin Lee ’04, PhD ’09 developed a silicone tube to improve treatment for interstitial cystitis, a bladder disease that causes painful and frequent urination. Fashioned with memory wire, the device could be straightened and injected into the bladder via catheter, then revert to its pretzel shape so it wouldn’t be expelled during urination. It slowly released the drug lidocaine over two weeks.

The device, described in a 2010 paper in the Journal of Controlled Release, was developed by Taris Biomedical, founded by Cima and Institute Professor Robert Langer of MIT’s Department of Biological Engineering. With initial funding from the Deshpande Center for Technological Innovation, Taris expanded its work in clinical trials.

In 2014, pharmaceutical company Allergan bought the rights to the device, called LiRIS (lidocaine releasing intravesical system). Taris continued to evolve the platform, exploring its potential for bladder cancer. Johnson & Johnson acquired Taris in 2019.

Cima reflected on the milestone. “It was a long road, but it is already saving lives,” he said.