Roche voluntarily withdraws the U.S. indication of Tecentriq (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma, a bladder cancer.
An estimated 81,000 cases of bladder cancer will be diagnosed in the United States in 2022. Urothelial carcinoma, which develops in the cells of the bladder lining, is the most common type of bladder cancer, accounting for about 90% of all cases. In total, 30% of cases are considered advanced based on muscle-invasive or metastatic disease.
After consultation with the U.S. Food and Drug Administration (FDA), Roche made this decision in accordance with the requirements of the FDA's Accelerated Approval Program.
The Company had designed the phase 3 trial to evaluate Tecentriq plus platinum-based chemotherapy for the first-line treatment of people with previously untreated advanced bladder cancer. But the trial did not meet the co-primary endpoint of overall survival (OS) for Tecentriq plus chemotherapy compared with chemotherapy alone.
In August 2022, Roche had also voluntarily withdrawn the US accelerated approval for Tecentriq® (atezolizumab) in combination with Abraxane for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer.
“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner. We remain confident in the benefit Tecentriq offers to people diagnosed with some of the most difficult-to-treat forms of cancer,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development.
