FDA Approves Inlexzo, a New Bladder Cancer Treatment
The Food and Drug Administration has approved Inlexzo, a Johnson & Johnson device that delivers chemotherapy directly into the bladder. The drug-release system was approved for patients with non-muscle invasive bladder cancer. Experts say the treatment could spare many patients from bladder removal surgery and cut down on repeated hospital visits.
A New Option Beyond Bladder Removal
For years, many patients with bladder cancer often faced a major choice: have their bladder removed or risk the disease progressing.
Roger Li, MD
“It is a big deal because it provides patients with another option for a bladder-sparing approach for the type of disease we’ve traditionally treated by removing the bladders,” said Roger Li, MD, a urologic oncologist in the Genitourinary Oncology Department at Moffitt Cancer Center. “It’s also a proof-of-concept that this drug-eluting platform can provide sustained treatment leading to durable response, while limiting systemic toxicity.”
Inlexzo, sometimes referred to as its trial name TAR-200, sits inside the bladder and steadily releases chemotherapy for three weeks at a time. Traditional bladder infusions can remain in place for only a couple of hours.
The approval was based on a clinical trial that showed higher than 82% complete response, with durable response at 12 months in 51% of the patients who received Inlexzo.
Less Hassle, Fewer Risks
The device could also make treatment less stressful. Standard bladder infusions require catheterization each time, which can lead to infections and urethral trauma, among other complications.
“With TAR-200, patients don’t need to come in as often, and that lowers risk,” Li said. “They wear it and forget about it. Most patients don’t feel it, and it doesn’t affect their urination or daily activities.”
A Path to Personalized Medicine
Li sees the approval as a step toward more personalized care. Because the tumor and the drug are inside the bladder, doctors can analyze urine samples during treatment to see how the cancer is changing.
“For the first time, we can track the tumor’s molecular changes in real time while the treatment is being delivered,” he said. “In theory, we could prevent recurrence and progression — essentially turning bladder cancer into a chronic disease that doesn’t significantly impact patients’ lives.”
The ability to tailor therapy could also extend the device’s usefulness to multiple drugs and different stages of disease. “We’re just scratching the surface of what this device can do,” Li said.
What’s Next?
Johnson & Johnson is now studying a similar pretzel-shaped device called TAR-210, which is designed to deliver the drug erdafitinib. It’s designed for patients with non-muscle invasive bladder cancer whose tumors have FGFR gene alterations, which are a driver of cancer growth. Moffitt is one of the leading sites involved in the clinical investigation.
“The accrual has been very robust,” Li said. “We’re hoping to finish the trial in the near future. The safety and efficacy we’ve seen so far continue to be very strong.”
