Feature|Articles|December 29, 2025
A Paradigm Shift in Bladder Cancer: Dr Jacob on the FDA Approval of TAR-200
Author(s)Sabrina Serani, Joseph M. Jacob, MD
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Key Takeaways
- TAR-200 offers a new treatment option for BCG-unresponsive NMIBC, potentially preserving bladders and achieving high response rates.
- The SunRISe-1 study showed an 82% complete response rate with TAR-200 monotherapy, outperforming combination therapies.
A groundbreaking bladder cancer treatment, TAR-200, offers new hope for patients failing first-line therapy, showcasing impressive response rates and ease of use.
The treatment landscape for bladder cancer has long faced a significant hurdle: how to manage patients who fail first-line therapy. Earlier this year, the
Filling the Void in Second-Line Therapy
For years, patients with high-risk non-muscle invasive bladder cancer (NMIBC) who were unresponsive to Bacillus Calmette-Guérin (BCG) faced a grim choice.
"This is a difficult patient population to treat,” Jacob explained. "They’ve had really very little in the way of options. Their most common option was, honestly, radical cystectomy. This is an unmet need and has been an unmet need for a long time."
TAR-200 serves as a highly efficacious salvage therapy. According to Jacob, it provides a vital alternative for those in the second-line setting, allowing patients to potentially preserve their bladders while achieving high response rates.
The SunRISe-1 Study: Unprecedented Results
The approval was driven by the SunRISe-1 study (NCT04640623), a phase 2b trial targeting BCG-unresponsive NMIBC.1The trial initially explored several cohorts, including combination therapies with checkpoint inhibitors. However, the TAR-200 monotherapy arm emerged as the clear leader.
"We quickly realized that TAR-200 monotherapy alone was going to be the best option for patients," Jacob said. "Believe it or not, TAR-200 monotherapy was better than combination therapy... it just became the single arm that we followed through the trial."
The study returned an 82% complete response rate, “the highest number that we’ve seen in this difficult patient population," Jacob noted. Over 50% of responders maintained their response for 12 months or longer.Jacob explained that these results were achieved under "pretty strict diagnostic criteria," including mandated biopsies and quarterly cystoscopy.
Accessibility and Ease of Use
What sets TAR-200 apart is its delivery system. Unlike traditional intravesical therapies that use liquid solutions, TAR-200 is a physical device placed directly in the bladder.
"This, in itself, is a paradigm shift," said Jacob. "We’ve never treated bladder cancer like this before. This is the first time we’ve really used a device to treat any type of bladder pathology."
Beyond clinical efficacy, Jacob emphasized the practical benefits for patients and private practices. Because the treatment is administered every 3 weeks rather than the traditional weekly schedule, it eases the burden on patients traveling long distances.
Furthermore, the shelf-stable nature of the device simplifies clinic logistics.
"There’s no specialized mixing. You don’t need a specialty pharmacy. This is really just something that comes prepared in a package, and you can leave it in the drawer of your clinic. That's a huge, huge win for patients in private practices who don't have specialty resources,” said Jacob.
Jacob also noted that the learning curve is minimal, mentioning that his nurse practitioner was able to take over placements and removals very quickly.
The Road Ahead: SunRISe-3 and Beyond
While the current approval focuses on the second-line setting, research is already moving into earlier stages of the disease.The ongoing SunRISe-3 trial (NCT05714202) is testing TAR-200 head-to-head against BCG in BCG-naïve patients.2
"This is such an awesome first step for us," Jacob concluded. "The more treatments that become available, the more we have to figure out how to sequence them. There’s going to be a lot more to talk about and a lot more research to be done."
