FDA Approves Innovative Bladder Cancer Treatment from MIT

The U.S. Food and Drug Administration (FDA) has approved a groundbreaking treatment system for aggressive bladder cancer, developed by researchers at the Massachusetts Institute of Technology (MIT). This innovative approach, which originated from a lab concept more than a decade ago, promises to significantly enhance the therapeutic options available for patients suffering from high-risk, non-muscle-invasive bladder cancer.

At the helm of this project were MIT Professors Michael Cima and Robert Langer, who co-founded the startup TARIS Biomedical LLC. Their work was supported by funding from the National Institutes of Health and MIT’s Deshpande Center. The FDA’s approval marks a significant milestone for the device, which is designed for localized drug delivery to the bladder, representing a new paradigm in cancer treatment.

In developing this system, the MIT team approached drug delivery as an engineering challenge. “We spoke to urologists and sketched out the problems with past treatments to get to a set of design parameters,” stated Cima, a David H. Koch Professor of Engineering. The design aimed to integrate seamlessly into existing urological procedures, allowing physicians to utilize the system without extensive training.

Clinical trials have demonstrated the system’s efficacy, with results showing that 82.4 percent of patients treated for high-risk bladder cancer showed no evidence of cancer following treatment. Remarkably, more than 50 percent of those patients remained cancer-free nine months post-treatment. These findings underscore the potential impact of this technology on patients’ lives.

Cima emphasized that the development of such drug products involves extensive collaboration. “There are probably more than 1,000 people that have been involved in developing and commercializing the system,” he noted. This included the MIT inventors, consulting urologists, scientists at TARIS, and those at Johnson & Johnson, which acquired TARIS Biomedical in 2019.

The journey began in the mid-2000s when Langer facilitated connections between Cima and a urologist at Boston Children’s Hospital seeking innovative treatments for interstitial cystitis, a painful bladder condition. Traditional treatments required frequent catheter infusions, offering only temporary relief. Cima and his team gathered insights from urologists and previous clinical trials, iteratively refining their design concepts.

One of the key advancements made by the research team was the use of a special alloy that provides the device with “shape memory.” This allows it to be inserted through a catheter and then expand within the bladder, releasing medication over a two-week period. This slow release is a significant improvement over previous methods, as it enhances treatment efficacy and patient comfort.

The FDA’s approval signals a new opportunity for patients facing this challenging cancer diagnosis. Moving forward, Cima expressed hope that this system could be adapted for treating additional diseases, further expanding its potential benefits.

“This is a great example of how research at the Koch Institute starts with basic science and engineering and culminates in new treatments for cancer patients,” said Langer, reflecting on the collaborative effort that brought this innovative treatment to fruition. The dedication of the MIT ecosystem to support ambitious projects has played a crucial role in transforming a scribbled idea into a viable medical solution.