Urologist describes early experience with gemcitabine intravesical system in NMIBC

In a recent interview with Urology Times, conducted at the 2025 LUGPA Annual Meeting, David Cahn, DO, MBS, FACOS, a urologist with MidLantic Urology in Pennsylvania, discussed his experience performing one of the first procedures using the gemcitabine intravesical system (Inlexzo) for the treatment of non–muscle invasive bladder cancer. Cahn expressed enthusiasm about offering this innovative therapy at MidLantic Urology, noting that it provides localized gemcitabine delivery over 21 days and represents a promising option for patients who have failed prior treatments.

He emphasized that implementing new therapies like the gemcitabine intravesical system requires coordinated support from clinical staff, administration, and industry partners to handle logistics such as insurance authorizations, ordering, and storage. According to Cahn, teamwork across these areas ensures smooth integration of cutting-edge treatments into community urology practice.

Cahn highlighted the FDA approval of the gemcitabine intravesical system as a significant milestone, citing study results showing an 82% overall complete response rate and 45% 1-year durability in patients who previously failed BCG therapy. This approval adds to a growing array of bladder-sparing options—now about 5 FDA-approved therapies—that enable patients to avoid radical cystectomy, a procedure often associated with substantial morbidity and life changes.

Discussing the gemcitabine intravesical system’s role in the evolving treatment landscape, Cahn described it as a strong addition among multiple effective agents. He stressed the importance of tailoring therapy based on individual factors such as disease state, patient comorbidities, and logistical considerations, noting the absence of biomarkers to guide precise treatment selection—an area he hopes will advance soon.

Looking ahead, Cahn expressed optimism about upcoming clinical trials exploring earlier intervention and biomarker-driven treatment strategies. He concluded by celebrating the rapid progress in bladder cancer care, likening it to the transformative growth seen in prostate cancer treatment, and reaffirmed his commitment to improving patient outcomes through innovation and collaboration.

Urology Times: You recently completed one of the first procedures with the gemcitabine intravesical system, or Inlexzo. What was your experience using this therapy?

Cahn: I'm very excited to bring this therapy to our patients in the Philadelphia area and to be able to offer it at MidLantic. This is a gemcitabine-releasing device that slow-releases chemotherapy into the bladder over 21 days. For this specific patient, he has been on multiple other medications previously, and we felt that this was most appropriate for him at this time. I'm certainly excited about the opportunity [for him to have this] type of therapy and that we're able to place it in this patient, and hopefully he has a complete result.

Urology Times: For community urologists, what are some of the logistical considerations like storage, handling and reimbursement when introducing a novel therapy like this?

Cahn: Whenever these new types of treatments come out, we have to have a lot of help. It's the clinical perspective, and of course, the patient come first. But we need support from administration and from staff, both from prior authorizations to ordering and storage and assistance - in this specific example, from [Johnson & Johnson] - and everybody works together as a team in order to make this happen for the patient. For something like this, of course, up front, we have to make certain that there are appropriate insurance coverages, and then once we have that appropriate clinical need, of course, and then move forward.

Urology Times: The gemcitabine intravesical system was recently FDA approved. Could you touch on the significance of that approval?

Cahn: We're really excited about that. In their study, they had about an 82% anytime complete response rate, and about a 45% complete response rate at 1 year. Those are really significant numbers for patients who have failed BCG therapy. There are a lot of good medications that have come to market that are out there right now, and it's an amazing time to be able to practice in this bladder cancer space to help our patients. Five to 10 years ago, there were no options, and patients who failed BCG therapy would have to have their bladder removed with a cystectomy. That's a very tough procedure. It has a lot of comorbidities associated with it, a lot of perioperative risks, and it is certainly a life-changing alteration for the patient. So now that we have really 5 options that are FDA approved in this space, we're really able to keep the patient's bladders right where they are for a longer period of time than ever before, and give them more treatment options, which I think, ultimately, is really kind of the goal, right? Let's identify the patients who have significant risk from their bladder cancer, and let's identify those patients who we believe can still have their bladder maintain where it is.

Urology Times: You mentioned that there's a wealth of options in the space right now. How do you see this system fitting into the treatment landscape, especially alongside some of those other options?

Cahn: Inlexzo is another great option that urologists have. There are a lot of very, very strong drugs that have come to market in order to treat these BCG failures and offer patients the best outcomes possible. Now, as a urologist, we have to weigh the risks and benefits of each one of these options. Are we using something that is in the bladder alone? Are we using a systemic agent? Do we have an infusion center? Is the patient able to travel? How often is the patient able to travel; what is their support structure? What's their bladder function like? I think when we're making this decision right now, we don't have biomarkers available, but ultimately that would be the goal to direct us. And right now, we're kind of using all of the other things that we want to consider, in addition to the pathology and the disease state, in order to make an informed decision with the patient.

Urology Times: Switching to the BCG-naive space, we've seen data recently from CREST, POTOMAC, and ALBAN. What role do you see for these BCG-ICI combinations?

Cahn: The data are very interesting. These 2 studies, one looking at a new sub[cutaneous] agent, and one looking at an IV infusion in addition to the BCG induction and maintenance, which had strong data to support it. Now, the question that we have is, are the patients who have bladder cancer tend to be in the older population, sometimes with comorbidities, can they withstand the adverse events of these [treatments], and as urologists, how do we balance that, and then how do we deal with some of these [adverse events]? I think again, ultimately, we're going to need biomarkers to decide which patients would benefit the most, and where we can take these risks and benefits and use them to help cure their disease.

Urology Times: What new agents or developments are you looking forward to in the future?

Cahn: We're ultimately looking forward to more of these clinical trials reading out in earlier populations, maybe papillary-only disease, patients without CIS or patients with BCG-naive disease. I think, ultimately, we really want some answers on how to use these agents earlier. [That's] really the goal of biomarkers - to direct urologists and to direct us to help patients with what drug would be most optimal for their disease state? Are there markers out there that can push us in terms of a chemotherapeutic or immunotherapeutic option? I think, hopefully, in the next few years, those will be developed so we can offer the best quality outcomes for our patients.

Urology Times: Is there anything you would like to add?

Cahn: It's been a really exciting time to be a bladder cancer champion in the Philadelphia area, and we've really modeled it after prostate cancer and all the growth that's been going in that space for the past 10 years. Hopefully, with the support of pharmaceutical companies, physicians, patients, and staff, we can continue to grow this space in order to really have the best possible outcomes for our patients.