New Bladder Cancer Treatment Approved

Patients with urothelial carcinoma, the most common type of bladder cancer, now have a new treatment option.

Patients with urothelial carcinoma, the most common type of bladder cancer, now have a new treatment option.

The FDA has approved atezolizumab (Tecentriq), the first PD-1/PD-L1 inhibitor approved to treat this kind of cancer.

“Products that block PD-1/PD-L1 interactions are part of an evolving story about the relationship between the body’s immune system and its interaction with cancer cells,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “…Tecentriq provides these patients with a new therapy targeting the PD-L1 pathway.”

Tecentriq is indicated for patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 1 year of receiving platinum-containing chemotherapy, either before or after surgical treatment.

The safety and efficacy of Tecentriq was studied in a clinical trial involving about 300 patients with locally advanced or metastatic urothelial carcinoma. Almost 15% of the patients showed at least some shrinkage of their tumors, and the effect lasted from around 2 to almost 14 months at the time of the response analysis.

In addition, the trial showed that patients who were positive for PD-L1 expression had a greater tumor response. Around one-quarter of the patients who were positive for PD-L1 experienced a tumor response, while around 9.5% of the patients classified as negative for PD-L1 expression showed a response.

“While patients who received Tecentriq experienced a tumor response across the study, the greater effect in those who were classified as positive for PD-L1 expression suggests that the level of PD-L1 expression in tumor-infiltrating immune cells may help identify patients who are more likely to respond to treatment with Tecentriq,” the FDA noted in a press release.

With this consideration, the FDA also approved the Ventana PD-L1 (SP142) assay to help determine patients’ PD-L1 protein expression, so that health care providers can better understand who would benefit most from the therapy.

Some adverse effects of Tecentriq include fatigue, decreased appetite, nausea, urinary tract infection, fever, and constipation.

More than 76,000 individuals will be diagnosed with bladder cancer this year, and about 16,000 of them will die from it, according to the National Cancer Institute.