The U.S. Food and Drug Administration (FDA) has approved a new treatment for certain types of bladder cancer — gemcitabine intravesical system (Inlexzo) — an implanted device that delivers cancer-fighting medication directly into the bladder. In clinical trials, 82 percent of participants experienced a complete response, meaning no signs of cancer were detected after treatment.

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What Is Inlexzo and How Does It Work?

Inlexzo is a drug-releasing system designed to deliver the cancer medication gemcitabine directly into the bladder over several weeks. It’s approved for adults with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. Previously, people with this type of cancer had limited treatment options if BCG therapy failed.

This approval is important for people who are either not eligible for or choose not to have radical cystectomy (surgical removal of the bladder).

Here’s how the treatment works:

• A healthcare professional places the device into the bladder using a small catheter, a process that takes only a few minutes and doesn’t require general anesthesia.
• The device stays in the bladder for three weeks, slowly releasing medication where it’s needed.
• A new device can be inserted every three weeks for six months, then every 12 weeks for up to 18 months, for a maximum of 14 treatment cycles.

How Did Inlexzo Perform in Clinical Trials?

The treatment approval was based on results from a phase 2b trial involving 83 adults with BCG-unresponsive NMIBC.

By the end of the study:

• Eighty-two percent of people who received treatment achieved a complete response, or no signs of cancer after treatment.
• Fifty-one percent of those who responded to the treatment maintained their complete response for at least one year.

What Are the Side Effects?

As with any medical treatment, this one comes with a risk of side effects. Common side effects (occurring in at least 15 percent of people) include:

• Frequent urination
• Urinary tract infection
• Painful urination
• Urgent need to urinate
• Blood in the urine
• Bladder irritation
• Changes in blood or lab values (e.g., low hemoglobin, increased creatinine)

Serious adverse reactions occurred in about 24 percent of participants, including urinary tract infection, blood in the urine, pneumonia, and urinary tract pain. Fatal adverse reactions occurred in 1.2 percent of people who received Inlexzo — including one case of cognitive disorder.

Although these risks are rare, it’s important to report any unusual symptoms to your healthcare provider right away.

How Does Inlexzo Expand Bladder Cancer Treatment Options?

For many people with high-risk NMIBC, the only treatment option after BCG therapy has been bladder removal, a major surgery that can significantly affect quality of life.

This gemcitabine-delivery system offers a bladder-sparing alternative, giving people another option to control their cancer without undergoing radical surgery.

The device’s outpatient administration and targeted delivery make treatment more convenient and reduce the need for hospital stays or systemic chemotherapy.

If you’re living with NMIBC and have questions or concerns about your current treatment plan, speak with your urologist or oncologist. Together, you can create a treatment plan that best meets your specific needs and goals.

Learn more about bladder cancer treatment options, including surgery, immunotherapy, and more.

Join the Conversation

On MyBladderCancerTeam, people share their experiences with non-muscle-invasive bladder cancer, get advice, and find support from others who understand.

Have you spoken with your doctor recently about your current treatment plan? Let others know in the comments below.