South San Francisco, CA — November 28th, 2022 —
Genentech, a member of the Roche Group, today announced 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.
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.Tecentriq U.S. Indications
Tecentriq is a prescription medicine used to treat adults with:The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.
A type of lung cancer called non-small cell lung cancer (NSCLC).
A type of lung cancer called small cell lung cancer (SCLC). Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as their first treatment when their lung cancer:
A type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq may be used with the medicine bevacizumab when their liver cancer:
A type of skin cancer called melanoma. Tecentriq may be used with the medicines cobimetinib and vemurafenib in patients with melanoma when their skin cancer:
It is not known if Tecentriq is safe and effective in children.
Important Safety Information
What is the most important information about Tecentriq?
Tecentriq can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe or life threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during their treatment or even after their treatment has ended.
Patients should call or see their healthcare provider right away if they develop any new or worse signs or symptoms, including:
Lung problemsIntestinal problems
Liver problems
Hormone gland problems
Kidney problems
Skin problems
Problems can also happen in other organs.
These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Patients should call or see their healthcare provider right away for any new or worse signs or symptoms, including:
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if patients undergo transplantation either before or after being treated with Tecentriq. A healthcare provider will monitor for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider will check patients for these problems during their treatment with Tecentriq. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may also need to delay or completely stop treatment with Tecentriq if patients have severe side effects.
Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of Tecentriq when used alone include:
The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:
The most common side effects of Tecentriq when used in hepatocellular carcinoma (HCC) with bevacizumab include:
The most common side effects of Tecentriq when used in melanoma with cobimetinib and vemurafenib include:
Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.
These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.
Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at 1-888-835-2555.
Please see http://www.Tecentriq.com for full Prescribing Information and additional Important Safety Information.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
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Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.