In patients with BCG-unresponsive, high-risk, non–muscle-invasive bladder cancer (NMIBC), the TAR‑200 gemcitabine‑releasing intravesical delivery system could enhance bladder‑preserving therapy for this patient population, according to Joseph Jacob, MD, MCR.
On July 17, 2025, the FDA granted priority review to a new drug application (NDA) seeking the approval of TAR-200 for the treatment of patients with BCG-unresponsive, high-risk NMIBC with carcinoma in situ (CIS), with or without papillary tumors, based on findings from the phase 2 SunRISe‑1 trial (NCT04640623).
The study showed that patients treated with TAR-200 experiencd a complete response (CR) rate of 82.4%; in patients who achieved a CR, 52.9% (95% CI, 72.6%-89.8%) were disease free for at least 1 year.
In an interview with OncLive®, Jacob discussed the background and rationale for the SunRISe‑1 trial, the significance of the efficacy findings, and considerations for incorporating TAR‑200 into clinical practice for patients with BCG‑unresponsive NMIBC if the agent is approved. Jacob is an associate professor of urology at SUNY Upstate Medical University in Syracuse, New York.
OncLive: What is the significance of the FDA granting priority review to TAR‑200 for this patient population?
Jacob: It’s an exciting time for bladder cancer. There have been some drugs approved in this space, but for clarity, [TAR-200] applies to patients who have received BCG and have been deemed unresponsive by their urologists. This is a pretreated population—classically difficult to treat—where the standard option was radical cystectomy, which is a life‑changing operation.
Until recently, [we’ve had] very few effective options in this space. We’re excited to think about TAR‑200 as a possible option for this patient population. I would honestly call this a paradigm shift, not only because of its efficacy, but also because it’s a completely different way of treating bladder cancer.
[TAR-200] is actually a device: an intravesical implant placed into the bladder [that provides] sustained‑release gemcitabine over at least 7 days. [By contrast, prior] intravesical therapies [typically] achieve dwell times of only 1 to 2 hours, [after which] patients will void the agent, whether [the drug be] immunotherapy, BCG, or chemotherapy. This is the first time we’ve been able to leave a device in the bladder and [allow a proven drug] like gemcitabine to penetrate more effectively.
The delivery system could [potentially be used] with gemcitabine or with other drugs in the future. This approach has the potential to expand our treatment options for this challenging patient population.
What patient population was included in SunRISe-1 trial, and why is this group considered particularly challenging to treat?
These are patients who were unresponsive to BCG [by the] classic FDA definition, which means that patients had to have received an induction course—at least 5 doses of BCG—and then at least 2 doses of maintenance therapy. These were patients with CIS, with or without papillary disease. The reason that’s important is that CIS is not considered a surgical disease. Most people agree that you can’t reliably clear CIS surgically, so you’re evaluating the efficacy of the drug.
In this setting, the primary end point we’re looking at is CR rate because these patients had CIS. These were patients who were either ineligible for cystectomy or refused cystectomy. Most of these patients were eligible for surgery; however, they were adamant about bladder preservation. In fact, more than 90% of these patients were technically eligible for cystectomy but [strongly preferred] to preserve their bladder.
What were the key efficacy findings from SunRISe-1?
The overall CR rate was 82.4% [per] central review. This was based on quarterly cystoscopy, central cytology, and mandated biopsies at 6 months and 12 months. [The trial used] rigid criteria.You needed both negative cytology and negative pathology on biopsies [to be considered in CR].
What key factors do you consider when determining whether cystectomy can be safely omitted in patients with BCG-unresponsive NMIBC, and how do these influence discussions about bladder preservation?
We live this and we have these conversations, [but ultimately], the patients have to make these decisions. In my practice, I’ve seen that if you give the patient any other option besides cystectomy, they are really drawn to that and want to know [more] about it. Sometimes patients don’t have another option. However, if there is something reasonable that we can offer and the doctors believe in it, patients will almost always choose something besides cystectomy.
The reason is that they don’t want to [undergo removal of the bladder]. It’s not just losing an organ; it’s adapting to a totally different quality of life. They’ll never urinate in quite the same way again. Regardless of what type of urinary diversion [they choose], it’s still a huge quality-of-life change.
[Cystectomy] is also a big surgery. Patients usually stay in the hospital for [approximately] 3 to 5 days on average, and it often takes a few months to recover. The complication rate, even in the best of hands, is around 30%, according to the literature. We do these surgeries for a living, and we can get patients through them, but if there’s a good or reasonable alternative, patients will be drawn to it. Honestly, urologists who want to do the best thing for their patients are going to be drawn to these bladder-preservation options as well.
What are some of the potential advantages of the TAR‑200 delivery system?
[TAR-200] is the first of its kind. It’s a new approach, and they did a good job. The team that designed this included urologists. The way you place it is just like placing a urinary catheter. You insert the catheter, you get some urine return, and then you take this flexible drug‑eluting intravesical system. You can straighten it out and insert it through the catheter. Then there’s an operator—you push it in and deploy it in the bladder. There’s a little opening in the catheter, and it gets deployed in the bladder. It’s very intuitive. Urologists obviously know how to place catheters, but here you also feel when it deploys in the bladder. You pull the catheter out, and if you’re unsure, you can look inside the bladder to confirm placement.
It’s a quick procedure and does not [require] anesthesia, so it’s done in the clinic. My nurse practitioner does a lot of these for me. It takes about a minute for us, and patients tolerate it well. The nice thing is, once the procedure is complete, you don’t see the patient again for 3 weeks. Most intravesical agents are given as an induction course once a week for 6 weeks, which is the most common schedule. This can be better for patients traveling long distances who can’t come every week but can come every 3 weeks.
Another advantage is that it’s easy for my clinic staff to use. It comes prepackaged, you can keep it on a shelf, and when needed, you just unpack it and give it to the patient. It doesn’t require a specialty pharmacy, freezer, or anything like that.
It is different, though the patients do have an indwelling device, and that’s part of [the procedure], but in my experience, it’s pretty well tolerated. Patients just need to realize there’s a chance they’ll feel that they have an indwelling device.
What is your key advice for clinicians considering the use of TAR‑200 in patients with BCG‑unresponsive NMIBC?
My advice is [that] this is something worthwhile, not just because it can be more practical or convenient for patients, but because it is an intuitive approach. Urologists can do this [procedure] easily and quickly. Most importantly, it’s efficacious.
Reference
Johnson & Johnson receives U.S. FDA Priority Review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer. News Release. Johnson & Johnson. July 17, 2025. Accessed July 17, 2025. https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-u-s-fda-priority-review-for-tar-200-nda-in-high-risk-non-muscle-invasive-bladder-cancer