SOUTH SAN FRANCISCO, CA, USA I November 28, 2022 I 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:
A type of bladder and urinary tract cancer called urothelial carcinoma.
Tecentriq may be used in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery, and if they have any one of the following conditions:
- they are not able to take chemotherapy that contains a medicine called cisplatin and their cancer tests positive for “PD-L1”, or
- they are not able to take chemotherapy that contains any platinum regardless of the levels of “PD-L1”
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).
- Tecentriq may be used alone as a treatment for their lung cancer:
- to help prevent their lung cancer from coming back after their tumor(s) has been removed by surgery and they have received platinum-based chemotherapy, and
- they have stage 2 to 3A NSCLC (patients should talk to their healthcare provider about what these stages mean), and
- their cancer tests positive for “PD-L1”.
- Tecentriq may be used alone as their first treatment when their lung cancer:
- has spread or grown, and
- their cancer tests positive for “high PD-L1”, and
- their tumor does not have an abnormal “EGFR” or “ALK” gene
- Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer:
- has spread or grown, and
- is a type called “non-squamous NSCLC,” and
- their tumor does not have an abnormal “EGFR” or “ALK” gene
- Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer:
- has spread or grown, and
- is a type called “non-squamous NSCLC,” and
- their tumor does not have an abnormal “EGFR” or “ALK” gene
- Tecentriq may be used alone when their lung cancer:
- has spread or grown, and
- they have tried chemotherapy that contains platinum, and it did not work or is no longer working
- if their tumor has an abnormal “EGFR” or “ALK” gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working
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:
- is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown.
A type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq may be used with the medicine bevacizumab when their liver cancer:
- has spread or cannot be removed by surgery, and
- they have not received other medicines by mouth or injection through their vein (IV) to treat their 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:
- has spread to other parts of the body or cannot be removed by surgery, and
- has a certain type of abnormal “BRAF” gene. Healthcare providers will perform a test to make sure this Tecentriq combination is right for the patient.
It is not known if Tecentriq is safe and effective in children.
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.
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.
SOURCE: Genentech
Post Views: 387
SOUTH SAN FRANCISCO, CA, USA I November 28, 2022 I 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:
A type of bladder and urinary tract cancer called urothelial carcinoma.
Tecentriq may be used in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery, and if they have any one of the following conditions:
- they are not able to take chemotherapy that contains a medicine called cisplatin and their cancer tests positive for “PD-L1”, or
- they are not able to take chemotherapy that contains any platinum regardless of the levels of “PD-L1”
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).
- Tecentriq may be used alone as a treatment for their lung cancer:
- to help prevent their lung cancer from coming back after their tumor(s) has been removed by surgery and they have received platinum-based chemotherapy, and
- they have stage 2 to 3A NSCLC (patients should talk to their healthcare provider about what these stages mean), and
- their cancer tests positive for “PD-L1”.
- Tecentriq may be used alone as their first treatment when their lung cancer:
- has spread or grown, and
- their cancer tests positive for “high PD-L1”, and
- their tumor does not have an abnormal “EGFR” or “ALK” gene
- Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer:
- has spread or grown, and
- is a type called “non-squamous NSCLC,” and
- their tumor does not have an abnormal “EGFR” or “ALK” gene
- Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer:
- has spread or grown, and
- is a type called “non-squamous NSCLC,” and
- their tumor does not have an abnormal “EGFR” or “ALK” gene
- Tecentriq may be used alone when their lung cancer:
- has spread or grown, and
- they have tried chemotherapy that contains platinum, and it did not work or is no longer working
- if their tumor has an abnormal “EGFR” or “ALK” gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working
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:
- is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown.
A type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq may be used with the medicine bevacizumab when their liver cancer:
- has spread or cannot be removed by surgery, and
- they have not received other medicines by mouth or injection through their vein (IV) to treat their 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:
- has spread to other parts of the body or cannot be removed by surgery, and
- has a certain type of abnormal “BRAF” gene. Healthcare providers will perform a test to make sure this Tecentriq combination is right for the patient.
It is not known if Tecentriq is safe and effective in children.
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.
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.
SOURCE: Genentech
Post Views: 387
