Genentech Provides Update on Tecentriq U.S. Indication for Previously Untreated Metastatic Bladder Cancer

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:
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.

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 problems

• cough
• shortness of breath 
• chest pain 

Intestinal problems  

• diarrhea (loose stools) or more frequent bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus 
• severe stomach-area (abdomen) pain or tenderness 

Liver problems  

• yellowing of the skin or the whites of the eyes 
• severe nausea or vomiting 
• pain on the right side of their stomach area (abdomen)
• dark urine (tea colored) 
• bleeding or bruising more easily than normal  

Hormone gland problems 

• headaches that will not go away or unusual headaches 
• eye sensitivity to light 
• eye problems 
• rapid heartbeat 
• increased sweating 
• extreme tiredness 
• weight gain or weight loss 
• feeling more hungry or thirsty than usual 
• urinating more often than usual 
• hair loss 
• feeling cold 
• constipation 
• their voice gets deeper 
• dizziness or fainting 
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness  

Kidney problems  

• decrease in their amount of urine 
• blood in their urine
• swelling of their ankles 
• loss of appetite  

Skin problems   

• rash 
• itching 
• skin blistering or peeling     
• painful sores or ulcers in mouth or nose, throat, or genital area 
• fever or flu-like symptoms 
• swollen lymph nodes  

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:

• Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
• Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• Persistent or severe muscle pain or weakness, muscle cramps
• Low red blood cells, bruising                            

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: 

• chills or shaking 
• itching or rash 
• flushing 
• shortness of breath or wheezing
• dizziness 
• feeling like passing out 
• fever 
• back or neck pain 

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:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to their chest area
• have a condition that affects their nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq. Females who are able to become pregnant: 
• A healthcare provider should do a pregnancy test before they start treatment with Tecentriq
• They should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq
• are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into the breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq

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:

• feeling tired or weak
• decreased appetite
• nausea
• cough
• shortness of breath

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

• feeling tired or weak
• nausea
• hair loss
• constipation
• diarrhea
• decreased appetite

The most common side effects of Tecentriq when used in hepatocellular carcinoma (HCC) with bevacizumab include:

• high blood pressure 
• feeling tired or weak 
• too much protein in the urine

The most common side effects of Tecentriq when used in melanoma with cobimetinib and vemurafenib include:

• skin rash 
• joint, muscle, or bone pain 
• feeling tired or weak 
• liver injury 
• fever 
• nausea 
• itching 
• swelling of legs or arms 
• mouth swelling (sometimes with sores) 
• low thyroid hormone levels 
• sunburn or sun sensitivity

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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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.