The U.S. Food and Drug Administration (FDA) has approved Inqlso (formerly Tar200) – an innovative local treatment for patients with bladder cancer of the carcinoma in situ (CIS) type that is resistant to BCG. Until now, for these patients, the main option to prevent disease progression was complete bladder removal – a complex surgery with extensive functional implications.
This is a tiny device that is inserted into the bladder using a catheter, without the need for anesthesia. After insertion, it expands into a ring shape and releases a chemotherapeutic substance in a controlled manner over three weeks. It is then replaced through another simple procedure.
In the clinical trials:
• About 97% of patients achieved a complete response after three months.
• More than 85% maintained a stable response for at least a year.
• The recorded side effects were local, temporary, and relatively mild in severity.
These data led the FDA to approve the treatment through an accelerated pathway.
About 2,000 new patients every year in Israel
In Israel, about 2,000 new patients are diagnosed each year with bladder cancer. The disease is most common in people in their 60s to 80s and is 5–6 times more prevalent among smokers.
In about 75% of cases, the disease is detected at a relatively early stage, when the tumor is superficial and does not penetrate the bladder muscle. In such cases, the tumor is usually surgically removed or cauterized, followed by local treatment with BCG (a weakened bacterium that triggers an immune response) or local chemotherapy.
About 25% of patients are defined as high-risk for recurrence. In one-third of them, even treatment with BCG is ineffective, and the disease returns. For these patients, until now, the only solution to reduce the risk of disease spread was complete bladder removal surgery.
The new treatment provides a solution for this group of patients. It allows for continuous, local, and controlled therapy, with a good safety profile and much higher response rates than the treatments previously available. However, experts emphasize that close monitoring is still required to detect recurrence early, even during this treatment.
Warning signs for early diagnosis
According to clinical data, 95% of patients report the appearance of blood in the urine as the first sign. Although in most cases this is caused by benign factors, any instance of bleeding—especially at an older age—requires a full examination:
• Urine test to detect cancerous cells
• Dedicated CT scan
• Cystoscopy – insertion of a camera via catheter to examine the bladder
The FDA approval marks an important milestone for patients with BCG-resistant bladder cancer. Inqlso offers a treatment alternative that reduces the need for complete bladder removal and enables better quality of life. However, even with this treatment, strict medical monitoring is required for early detection of disease recurrence.