Gemcitabine Intravesical System Changes the Paradigm of Bladder Cancer Treatment

In an interview with Targeted Oncology, Joseph Jacob, MD, MCR, associate professor of urology at SUNY Upstate University Hospital, discusses the unmet needs that the gemcitabine intravesical delivery Inlexzo (formerly TAR-200) fills in the treatment landscape for patients with Bacillus Calmette-Guérin (BCG)–unresponsive bladder cancer. The drug was recently approved by the FDA.

Jacob notes that is a challenging patient population to treat. These are patients who have already failed first-line therapy and have had very few treatment options available to them. Historically, the most common option was radical cystectomy. While some drugs have emerged, there has been a lack of substantial data regarding their efficacy. This new drug offers an effective solution for second-line treatment in patients who are unresponsive to BCG therapy, addressing a long-standing unmet need in bladder cancer treatment due to the lack of effective salvage therapies.

The new treatment approach is also different from traditional methods. Typically, patients come in for weekly treatments for 6 weeks, with a solution placed in their bladder. With this new approach, patients are only seen once every 3 weeks, which is a significant benefit, especially for those who travel long distances. This reduced frequency was appreciated by patients in clinical trials.

The drug is also very accessible. It does not require specialized mixing or a specialty pharmacy. It comes preprepared in a package and can be easily stored in a clinic drawer. This ease of use is a major advantage, particularly for private practices and clinics with limited resources.

Jacob notes that there were initial concerns about inserting the device into the bladder, as this was a novel procedure. However, the insertion process proved to be much easier than anticipated. The catheter is well-designed, and there were no issues with placement. The procedure is quick, similar to inserting a regular catheter. The drug is then deployed, with the entire process taking about 15 seconds.

Removal is also straightforward, similar to what urologists are accustomed to: a cystoscopy is performed, a flexible stent grasper is used, and the device is removed. Jacob says the nurse practitioner in his clinic was quickly able to learn and perform both the insertions and removals.