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FDA grants accelerated approval to Tecentriq for advanced urothelial carcinoma
The FDA granted accelerated approval to atezolizumab for the initial treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy, according to the drug’s manufacturer.
Atezolizumab (Tecentriq, Genentech) is a monoclonal antibody designed to bind with PD-L1 on tumor cells and tumor-infiltrating immune cells.
“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,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release.
The FDA based the approval on results from one of two cohorts in the open-label, multicenter, single-arm phase 2 IMvigor210 study, designed to evaluate the safety and efficacy of atezolizumab in patients with locally advanced or metastatic urothelial carcinoma regardless of PD-L1 expression.
The cohort included 119 patients who received 1,200 mg atezolizumab via IV every 3 weeks until disease progression or unacceptable toxicity.
Researchers reported an objective response rate of 23.5% (95% CI, 16.2-32.3). Results showed 6.7% of patients achieved complete response and 16.8% achieved partial response. Median duration of response had not been reached.
“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,” Andrea Maddox Smith, CEO of the Bladder Cancer Advocacy Network, said in the press release. “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.”
The most common grade 3 to 4 adverse reactions included hyponatremia (15%), fatigue (8%), anemia (7%), urinary tract infection (5%), diarrhea (5%) and increase in the level of creatinine in the blood (5%). Other grade 3 to grade 4 that occurred in at least 2% of patients included intestinal obstruction, increase of the liver enzyme alanine transaminase, decreased appetite, sepsis, back/neck pain, renal failure and hypotension.
Five patients (4.2%) discontinued treatment due to adverse reactions. Five patients (4.2%) experienced sepsis, cardiac arrest, myocardial infarction, respiratory failure or respiratory distress, which led to death.
The confirmatory phase 3 IMvigor211 study is underway to compare atezolizumab with chemotherapy as initial treatment for patients with a specific type of advanced bladder cancer, as well as for patients whose disease progressed on at least one prior platinum-containing regimen.
The FDA previously approved atezolizumab for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before or after surgery.
The drug also is approved for the treatment of patients with non-small cell lung cancer whose disease progressed during or following platinum-containing chemotherapy.