Tuesday, Apr 27, 2021

FDA Advisory Committee Votes in Favor of Maintaining Accelerated Approval of Genentech’s Tecentriq for PD-L1-Positive, Metastatic Triple-Negative Breast Cancer

South San Francisco, CA -- April 27, 2021 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 2 in favor of maintaining accelerated approval of Tecentriq^® (atezolizumab) in combination with chemotherapy (Abraxane^®, albumin-bound paclitaxel; nab -paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1, as determined by an FDA-approved test. Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts, though the recommendations are not binding. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

“People with triple-negative breast cancer have few treatment options, which is why today's committee decision to recognize the importance of this Tecentriq combination is significant,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are grateful to the FDA and ODAC for the open dialogue and look forward to continued collaboration to improve the lives of people with breast cancer.”

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 March 2019 for the treatment of adults with PD-L1-positive, unresectable locally advanced or mTNBC based on the positive progression-free survival (PFS) results from the IMpassion130 study. Continued approval for this indication was contingent upon the results of IMpassion131, the PMR for the mTNBC indication. This study did not meet its primary endpoint of PFS for the initial (first-line) treatment of people with mTNBC in the PD-L1-positive population. As the clinically meaningful benefit demonstrated in the IMpassion130 study remains, Genentech looks forward to continuing to work with the FDA to determine next steps with regard to Tecentriq in this indication.

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. Tecentriq’s 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.

Tomorrow, on April 28th, the ODAC will discuss Tecentriq’s accelerated approval for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy.

About triple-negative breast cancer
Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, close to 285,000 people in the United States will be diagnosed with invasive breast cancer, and more than 44,000 will die from the disease in 2021. Breast cancer is not one, but many diseases based on the biology of each tumor. In triple-negative breast cancer, tumor cells lack hormone receptors and do not have excess HER2 protein. Approximately 15 percent of breast cancers are triple-negative based on the results of diagnostic tests. It is an aggressive form of the disease with few treatment options.

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” status

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:

• Their 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 the first treatment in patients with lung cancer if:

• Their cancer has spread or grown, and
• Is a type of lung cancer 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 the first treatment in patients with lung cancer if:

• Their cancer has spread or grown, and
• Is a type of lung cancer called “non-squamous NSCLC”, and
• Their tumor does not have an abnormal “EGFR” or “ALK” gene.

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

• Their cancer has spread or grown, and
• They have tried chemotherapy that contains platinum, and it did not work or is no longer working.
• If a patient’s 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 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:

• Has spread or cannot be removed by surgery, and
• Their cancer tests positive for “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.

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:

• 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 in patients with HCC if :

• Their 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 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

• 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 the 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
• Changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
• Feeling more hungry or thirsty than usual
• Urinating more often than usual
• Hair loss
• Feeling cold
• Constipation
• The voice gets deeper
• Dizziness or fainting

Kidney problems

• Decrease in the amount of urine
• Blood in the urine
• Swelling of 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 a patient underwent transplantation either before or after being treated with Tecentriq. A patient’s 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:

• 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 the 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:
  • Should have a healthcare provider do a pregnancy test before they start treatment with Tecentriq.
  • 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 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
• Nausea
• Cough
• Shortness of breath
• Decreased appetite

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 triple-negative breast cancer with paclitaxel protein-bound include:

• Decrease in hemoglobin (anemia)
• Decreased white blood cells
• Hair loss
• Tingling or numbness in hands and feet
• Feeling tired
• Nausea
• Diarrhea
• Constipation
• Cough
• Headache
• Vomiting
• 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 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 Genentech’s approved PD-L1 checkpoint inhibitor, the company’s 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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