One year of Inlexzo: Evolving care in BCG-unresponsive NMIBC

The gemcitabine intravesical system (Inlexzo) was approved for patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors in September 2025.¹ This approval added another bladder-preserving treatment to a growing landscape previously characterized by a lack of effective options.

One year after the Inlexzo approval, Joseph Jacob, MD, sat down with Urology Times® to reflect on how the availability of new therapies has influenced treatment decision-making and patient selection in this disease space. He also shares his perspective on the evolving NMIBC treatment landscape, including the potential role of continuous drug-delivery systems and emerging approaches across disease-risk groups.

Urology Times: One year following its approval, how has Inlexzo affected the management of patients with BCG-unresponsive NMIBC?

Jacob: This has changed the way we approach this disease. I'm not that old of a urologist, but I still remember a time where these patients were booked for the OR—they were cystectomy patients. We had this treatment called Valstar [(Valrubicin)] that [wasn’t very efficacious], or we recommended going to the OR. Just the fact that there's another good drug that's available [is exciting]. We’ve seen with the SunRISe-1 trial (NCT04640623) that the progression rate is low, and the cystectomy rate is low, so we can tell patients, "We have another option for you, and it's safe."

Urology Times: Looking at the broader treatment landscape, how has the growing number of treatment options affected decision-making for patients with high-risk NMIBC?

Jacob: Being being able to make a decision with a patient is a beautiful thing in this disease space, because before, you were faced with either doing cystectomy or picking a treatment that we knew wasn't going to be effective. We still talk about cystectomy, don't get me wrong. That's one option, but now we have Inlexzo and other treatments that we can offer patients.

Urology Times: Which patients with BCG-unresponsive NMIBC are you considering for Inlexzo, and what factors most influence that decision?

Jacob: That's the million-dollar question, because patient selection is everything in this space. Patients need to hear that this is an option, and they need to hear about the data. But really, the biggest thing is we want to find out what the patient's goals are. If the patient's goal is to preserve the bladder, then I think that this is something that they take seriously. Not surprisingly, many patients are interested in bladder preservation.

Urology Times: What have you observed regarding treatment-related urinary symptoms and other adverse events with Inlexzo, and how do you manage those in practice?

Jacob: This is a big question, because this is a very different way of treating patients. Every other treatment out there is an intravesical solution, so the catheter goes in and it's a similar approach to BCG. It's a solution that fills up the bladder, and the treatment's done in 1 to 2 hours. [Inlexzo] is the only treatment approved right now that is an intravesical device that's placed into the bladder. It's a continuous release of gemcitabine to the bladder. This device stays in the bladder for 3 weeks. We haven't seen that before, so the way you manage these patients is different.

For the other drugs, you see patients every week, but for this drug, you don't see them for 3 weeks. That is a good thing—patients don't want to be in the office every week. However, it does require a little bit more counseling, since there is a time where you're not going to be able to interact with the patient as often as we're used to. So, right when we place the device, I may spend time going over the symptoms patients might have. For suprapubic pain or tenderness or discomfort, [they can] try ibuprofen or Tylenol. If they have overactive bladder symptoms like bladder spasms, I [let them know] that Ditropan is available, or there's Gemtesa [(vibegron)]. If they’re having dysuria, there's Uribel or Pyridium [(phenazopyridine)]. I tell them that there are things that are available, and they should call the office [if they have adverse events]. A lot of these patients are heavily pretreated, so in some patients I'll just tell them to continue their Ditropan or Gemtesa, just because we've seen how they do with BCG, so we can predict [their symptoms]. At the end of the day, this is an intravesical treatment, and patients are going to have dysuria, overactive bladder, suprapubic pain, [etc].

It is a new device and a new way of treating, but the symptoms and the AEs associated with this are very similar to what urologists are used to with BCG and other intravesical therapies. The biggest thing is the different timing. If you invest a little bit in the beginning, then it'll be less that you have to worry about in the future.

Urology Times: What are some of the logistical or workflow considerations for practices that are looking to implement Inlexzo?

Jacob: There are some advantages because it's a drug that comes almost like a stent in a package. You can put it on your shelf and it’s room temperature. I work at an academic institution, so it's not as big a deal for me, but I do have colleagues that work in private-practice offices where they don't have access to freezers and specialty pharmacies. This would be a drug that they could have in their shelves, locked up, of course, but they could have this in their clinic without any other consideration. That’s one thing that could be helpful, especially for our private-practice colleagues.

The other thing that that we touched on a little bit is that every 3 weeks is a lot easier for patients. I do have patients who are driving 3 hours to come see us from different areas of upstate New York, and so they can manage 3 weeks a little bit more vs every week.

Urology Times: What role can APPs play in the care pathway for these patients?

Jacob: This is a great question. My nurse practitioner does, I would say, half of these procedures in my practice. Urologists are busy, and we're not in clinic every day. My APP watched me [do this procedure] once, and she was able to do it. At the end of the day, if you can put a catheter into the bladder, you can place this device with an obturator. Inlexzo is removed the same exact way that a stent would be removed in the clinic. It's very intuitive, so it does not require the urologist to be there for every single placement and removal.

Urology Times: Looking across the broader bladder cancer treatment landscape, what developments do you think are going to have the greatest impact in NMIBC care over the next several years?

Jacob: It's an exciting time. BCG-unresponsive disease is just the tip of the iceberg. The treatments and the technology that's been developed and all the resources that have been poured into this space will help other patients with bladder cancer as well, so I think the future is extremely promising for bladder cancer patients.

Something that is similar to Inlexzo is another device where instead of having gemcitabine, it has erdafitinib. I think that will be exciting. SunRISe-3 [NCT05714202] was another trial that we had open and we accrued a lot of patients onto, [which looked at] Inlexzo, the gemcitabine continuous-releasing device, head-to-head against BCG in the BCG-naïve population. That's a bigger patient population that could benefit, especially in the setting of the BCG shortage, so that's an exciting population.

I also think that the intermediate-risk population is exciting. Urologists know [patients with] intermediate-risk [disease] can be challenging because they don't have aggressive disease, but they just keep recurring and they keep getting biopsies and procedures. There are more trials and more drugs coming out in this space. So, almost every [bladder cancer] space is being studied now, and I think there's going to be hopefully new drugs and new options for patients.

REFERENCE

1. U.S. FDA approval of INLEXZO (gemcitabine intravesical system) set to transform how certain bladder cancers are treated. News release. Johnson & Johnson. September 9, 2025. Accessed September 25, 2026. https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated