On November 28, 2022 Genentech, a member of the Roche Group, reported that the company is voluntarily withdrawing the U.S. indication of Tecentriq (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1–stained tumor-infiltrating immune cells covering ≥5% of the tumor area) or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status (Press release, Genentech, NOV 28, 2022, View Source,for%20cisplatin%2Dcontaining%20chemotherapy%20and [SID1234634770]).
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Genentech made this decision following consultation with the U.S. Food and Drug Administration (FDA), in accordance with the requirements of the FDA’s Accelerated Approval Program. The Phase III IMvigor130 trial was designed to evaluate Tecentriq plus platinum-based chemotherapy for the first-line treatment of people with previously untreated advanced bladder cancer. IMvigor130 was the designated postmarketing requirement (PMR) to convert the accelerated approval to regular approval, and it did not meet the co-primary endpoint of overall survival (OS) for Tecentriq plus chemotherapy compared with chemotherapy alone. These data will be presented at an upcoming medical meeting.
"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. "There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival."
This decision does not affect other approved indications for Tecentriq in the U.S.
Genentech will work with the FDA over the coming weeks to complete the withdrawal process and notify healthcare professionals in the U.S. about this withdrawal. Patients in the U.S. being treated with Tecentriq for previously untreated mUC should discuss their care with their healthcare provider.
About 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. There remains a high unmet need for people facing previously untreated advanced bladder cancer. Despite improvements in tolerability, there have been no efficacy improvements for more than 30 years with chemotherapy as standard of care, and patients continue to experience poor outcomes.
About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.