The United States Food and Drug Administration has just announced the accelerated approval of the new Genentech drug TECENTRIQ for the frontline treatment of locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible to take cisplatin chemotherapy. Previously, the drug, atezolizumab, was approved to treat patients who locally advanced or mUC with disease progression throughout or after platinum-containing chemotherapy or who are within 12 months of receiving such chemotherapy before going into surgery (neoadjuvant), or who had already been through surgery (adjuvant).
“We are pleased that Tecentriq will now be available to more people with advanced bladder cancer, including those who are unable to receive initial treatment with cisplatin chemotherapy,” explains Genentech chief medical officer and head of Global Product Development, Sandra Horning, MD. “Tecentriq was the first cancer immunotherapy approved by the FDA for people with advanced bladder cancer and has become a standard of care in those whose disease has progressed after receiving other medicines, either before or after surgery, or after their disease has spread.”
This accelerated regulatory approval is based on new data gathered during the single-arm phase II IMvigor210 trial. In this trial, study cohort of 119 cisplatin-ineligible, treatment-naive patients, the atezolizumab objective response rate (ORR) was 23.5% (n = 28; 95% CI, 16.2-32.2).
In response to the results and the approval, Bladder Cancer Advocacy Network chief executive officer Andrea Maddox Smith comments, “It is encouraging to see continued progress in the treatment of advanced bladder cancer, which until last year had not seen any major advancements in more than 30 years. We are excited that TECENTRIQ is now a treatment option for people with advanced bladder cancer who are unable to receive a cisplatin-based chemotherapy as an initial treatment.”
It is important to note, too, that Tecentriq can have serious side effects. These can include—but are not limited to: complications of the lungs, liver, intestines, hormonal glands, nervous system, eyes, pituitary gland, thyroid, and adrenal glands; as well as eye problems and some severe infections.
In light of those potential side effects the most common grade 3/4 adverse events include fatigue, urinary tract infection, anemia, and diarrhea, all of which only occurred in 5 to 10 percent of patients. Other potential adverse, though less common, can include decreased appetite, back/neck pain, hyponatremia, and elevated levels of creatinine and liver enzyme in the blood.