MIT-Developed Bladder Cancer Treatment Receives FDA Approval

A novel bladder cancer treatment system, originally conceived in the laboratory of Professor Michael Cima at MIT, has received approval from the U.S. Food and Drug Administration (FDA) for use in patients with high-risk, non-muscle-invasive bladder cancer (NMIBC). The FDA decision, announced on September 11, 2025, represents a significant milestone for both the MIT research community and the broader field of cancer therapeutics.

The newly approved system, which began as a whiteboard concept at MIT’s Koch Institute for Integrative Cancer Research, was developed into a commercial product by TARIS Biomedical LLC, a startup co-founded by Cima and Professor Robert Langer. Johnson & Johnson acquired TARIS in 2019, further advancing the technology through clinical trials and regulatory review. The device delivers medication directly to the bladder, offering a targeted, minimally invasive alternative to traditional therapies, which often require radical cystectomy or frequent chemotherapy instillations.

Transforming Bladder Cancer Care

Clinical studies have demonstrated the system’s effectiveness, with one trial showing that 82.4 percent of patients with BCG-unresponsive NMIBC had no evidence of cancer following treatment. More than half of these patients remained cancer-free nine months later. The system’s design allows for quarterly dosing, reducing the treatment burden and improving patient convenience compared to existing protocols. According to Ferring Pharmaceuticals, which is also advancing similar gene therapy approaches, this marks the first FDA-approved intravesical non-replicating gene therapy for adult patients with high-risk NMIBC.

MIT’s Role and Industry Collaboration

Professor Cima emphasized the collaborative nature of the project, noting that over 1,000 individuals contributed to the development and commercialization of the system, including MIT inventors, urologists, scientists at TARIS and Johnson & Johnson, and clinical trial participants. The MIT ecosystem, with its support for innovative and high-risk ideas, played a crucial role in bringing the technology from concept to clinical reality. Cima stated, "Drug products like this take an enormous amount of effort. We need to continue to support those kinds of activities."

Regulatory and Industry Response

The FDA’s approval is expected to set a new standard of care for patients with high-risk NMIBC, particularly those who do not respond to Bacillus Calmette-Guérin (BCG) therapy. Industry leaders, including Ferring Pharmaceuticals, have highlighted the importance of bladder-sparing treatment options and the potential for gene therapy to transform outcomes for patients who previously faced limited choices. The approval also validates years of research and investment in local drug delivery systems and gene therapy for cancer.

The news has been widely reported by local, national, and international outlets, reflecting the global significance of the FDA’s decision and the potential impact on cancer care worldwide. The approval is expected to accelerate further research and adoption of advanced therapies for bladder cancer, offering hope to thousands of patients each year.