South San Francisco, CA — December 9th, 2022 —
Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) for the treatment of adult and pediatric patients two years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS). ASPS is a rare, insidious soft tissue sarcoma most common in younger people that is often advanced at diagnosis, can spread slowly but inexorably over decades, and often returns following surgery. For those diagnosed with advanced ASPS, only an estimated 20% will live five years.
“This approval brings new hope for children, adults and their families affected by advanced alveolar soft part sarcoma, who historically have had very limited treatment options,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Developing new therapies in rare diseases is especially challenging, but we are committed to meeting such challenges, with the goal of helping as many people as possible.”
The approval is based on results from a Phase II single-arm study funded and conducted by the National Cancer Institute, part of the National Institutes of Health, with Genentech support, in 49 adult and pediatric patients with unresectable or metastatic ASPS. Results showed that treatment with Tecentriq produced an overall response rate (ORR) of 24%. Of the 12 patients who experienced an objective response, 67% had a duration of response (DOR) of 6 months or more, and 42% had a DOR of 12 months or more. Serious adverse reactions occurred in 41% of patients receiving Tecentriq. The most frequent serious adverse reactions (>2%) were fatigue, pain in extremity, pulmonary hemorrhage, and pneumonia (4.1% each).
Genentech thanks the National Cancer Institute and the patients and investigators from the NCI-funded Experimental Therapeutics Clinical Trials Network who participated in this important research.
About alveolar soft part sarcoma (ASPS)
ASPS is among the rarest cancers, with about 80 cases diagnosed each year in the United States, most commonly among young adults. ASPS tumors can grow slowly and asymptomatically, leading to most cases being diagnosed in advanced stages. Historically, treatment for ASPS has been limited to surgery for the primary location where the sarcoma arises, and systemic therapy is frequently the only option when the tumor spreads. Patients can live with ASPS for years and even decades, undergoing repeated surgeries to keep the disease at bay; however, recurrences are common.
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.
What is Tecentriq?
Tecentriq is a prescription medicine used to treat:
Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).
Adults with 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:
Adults with a type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq may be used with the medicine bevacizumab when their liver cancer:
Adults with 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:
Adults and children 2 years of age and older with a type of soft tissue tumor (cancer) called alveolar soft part sarcoma (ASPS). TECENTRIQ may be used when your sarcoma:
It is not known if Tecentriq is safe and effective when used:
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
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 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.