FDA Advisory Committee Votes in Favor of Maintaining Accelerated Approval of Genentech’s Tecentriq for Previously Untreated Metastatic Bladder Cancer…

Todays positive vote reaffirms that Tecentriq fills a significant unmet need for people with previously untreated metastatic bladder cancer, many of whom cannot tolerate standard of care chemotherapy and need additional options, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. Having now received positive ODAC recommendations in both bladder cancer and triple-negative breast cancer, we will continue to work with the FDA on next steps for Tecentriq in these indications.

The FDA's Accelerated Approval Program allows for conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific postmarketing requirements (PMRs) to confirm the clinical benefit and convert to regular approval.

Tecentriq was granted accelerated approval in 2017 for the treatment of adults with locally advanced or mUC who are not eligible for cisplatin-containing chemotherapy based on the positive overall response rate and duration of response results from the IMvigor210 study. Tecentriqs indication was subsequently focused on PD-L1 high patients, who would benefit the most based on findings from the IMvigor130 study in 2018. This Phase III trial is the designated PMR for the first-line mUC indication and met its co-primary endpoint of progression-free survival. IMvigor130 continues for overall survival (OS). Genentech looks forward to sharing the final OS results once available.

Genentech remains committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment. Tecentriq has already demonstrated its transformational role in areas of high medical need and is a first in class medicine approved for particularly difficult to treat cancers. Tecentriqs extensive development program includes multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings.

Yesterday, on April 27th, the ODAC voted 7 to 2 in favor of maintaining the accelerated approval of Tecentriq in combination with nab-paclitaxel for the treatment of people with PD-L1-positive, metastatic triple-negative breast cancer.

About bladder cancer

According to the American Cancer Society (ACS), it is estimated that close to 84,000 Americans will be diagnosed with bladder cancer in 2021, and about 11 percent of new diagnoses are made when bladder cancer is in advanced stages. There is a dramatic difference in survival rates between early and advanced bladder cancer. The ACS estimates that approximately 95 percent of people will live five or more years when diagnosed with the earliest stage of the disease, compared to 40 percent when diagnosed in advanced stages (stage III-IV) of the disease. Men are about three times more likely to get bladder cancer during their lifetime than women.

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:

The approval of Tecentriq in these patients is based on a study that measured response rate and duration of response. 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 the first treatment in patients with lung cancer if:

Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as the first treatment in patients with lung cancer if:

Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as the first treatment in patients with lung cancer if:

Tecentriq may be used alone in patients with lung cancer if:

A type of breast cancer called triple-negative breast cancer (TNBC).

Tecentriq may be used with the medicine paclitaxel protein-bound in patients with TNBC when their breast cancer:

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.

Tecentriq is not for use with the medicine paclitaxel (a different medicine than paclitaxel protein-bound) in patients with TNBC when their breast cancer has spread or cannot be removed by surgery.

A type of lung cancer called small cell lung cancer (SCLC). Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as the first treatment in patients with SCLC when their lung cancer:

A type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq may be used with the medicine bevacizumab in patients with HCC if:

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 treatment or even after 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

Intestinal 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 a patient underwent transplantation either before or after being treated with Tecentriq. A patients healthcare provider will monitor them 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 triple-negative breast cancer with paclitaxel protein-bound 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 their 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 (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please visit http://www.Tecentriq.com for the Full Tecentriq Prescribing Information and Medication Guide for additional Important Safety Information.

About Genentech in cancer immunotherapy

Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentechs approved PD-L1 checkpoint inhibitor, the companys broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit http://www.gene.com/cancer-immunotherapy.

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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FDA Advisory Committee Votes in Favor of Maintaining Accelerated Approval of Genentech's Tecentriq for Previously Untreated Metastatic Bladder Cancer...