The FDA just granted approval to a new biologic medication to treat bladder cancer, Tecentriq (atezolizumab). While Tecentriq is certain to help many people with this type of cancer, it is important to note the side effects associated with the drug, as well as the fact no studies or data exist about the long-term impacts of using Tecentriq.
About 77,000 new cases of bladder cancer are expected to be diagnosed this year in the United States, along 16,000 deaths, the American Cancer Society reports. Around 75% of those cases will be in men.
Tecentriq was approved to treat people with an advanced kind of a bladder cancer called urothelial carcinoma. It can only be prescribed if the cancer has continued despite more standard forms of chemotherapy.
The drug, which is given via intravenous infusion, is the fourth to be approved by the agency that is in a class known as checkpoint inhibitors. They work by unleashing an immune system response on cancer cells. In particular, Tecentriq prevents a protein called PD-L1 from binding to the PD-1 protein on T cells, impacting the body’s immune response.
Other checkpoint inhibitors on the market today are Keytruda (pembrolizumab) to treat melanoma and lung cancer, Opdivo (nivolumab) to treat melanoma (a form of skin cancer), lung cancer, kidney cancer, and Hodgkin’s lymphoma, a kind of blood cancer, and Yervoy (ipilimumab) to treat melanoma.
Tecentriq was approved based on a trial that found the biologic shrank tumors significantly in 14.8% of patients, while the bladder cancer was completely eliminated in 5.5%. However, the study had no control group so there is no way to compare the results to a placebo group. In addition, it is unclear if Tecentriq leads to an increase in life expectancy in those with cancer.
Treatment with Tecentriq will be pricey. It will cost about $12,500 per month.
In the trials conducted of the drug, many side effects were seen. Among the most common were severe infections, which occurred in 38.4% of patients. These infections included sepsis, herpes encephalitis, and mycobacterial infection, the last leading to a kind of hemorrhage.
Colitis or diarrhea occurred in 18.7% of patients with urothelial carcinoma. Nearly 2% of patients developed serious diarrhea and about 1% had immune-mediated colitis. Corticosteroid treatment helped with several patients, though one patient who had colitis died as a result of diarrhea-associated kidney failure.
The most common side effects seen (in at least 20% of people given Tecentriq) were fatigue, decreased appetite, nausea, urinary tract infection, fever, and constipation.
In trials, clinical interstitial lung disease (pneumonitis), which required use of corticosteroid treatment, developed in 2.6% of patients. Two patients died as a result of fatal pneumonitis.