SOURCE: U.S. Food and Drug Administration, news release, May 18, 2016
THURSDAY, May 19, 2016 (HealthDay News) -- A new drug to treat bladder cancer was approved by the U.S. Food and Drug Administration on Wednesday.
Tecentriq (atezolizumab) treats the most common type of bladder cancer, called urothelial carcinoma. It's the first in its class of drugs, called PD-1/PD-L1 inhibitors, approved to treat this type of cancer.
"Tecentriq provides these patients with a new therapy targeting the PD-L1 pathway," Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
"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," he added.
The FDA approved Tecentriq for treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before or after surgery.
Urothelial carcinoma occurs in the urinary tract system, involving the bladder and related organs. An estimated 76,960 new cases of bladder cancer and 16,390 deaths from the disease will occur in the United States in 2016, according to the U.S. National Cancer Institute.
The FDA's approval of Tecentriq is based on a clinical trial involving 310 patients with locally advanced or metastatic urothelial carcinoma. Nearly 15 percent of patients had at least partial shrinkage of their tumors, which lasted from about 2 months to nearly 14 months at the time the data was analyzed, the study found.
Tumor response occurred in 26 percent of patients who were positive for PD-L1 expression, compared with 9.5 percent of those who were negative for PD-L1 expression, the findings showed. This suggests that patients who are positive for PD-L1 expression may be more likely to respond to treatment with Tecentriq.
Therefore, the FDA also approved a companion test to detect PD-L1 protein expression levels in patients, to help doctors identify those most likely to benefit from Tecentriq.
During the clinical trial, common side effects associated with Tecentriq were fatigue, decreased appetite, nausea, urinary tract infection, fever and constipation. The drug also has the potential to cause infection and serious immune system side effects involving healthy organs such as the lungs, colon and endocrine system, the FDA said.
Tecentriq is made by San Francisco-based Genentech.
The American Cancer Society has more about bladder cancer.