SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L11%, as determined by an FDA-approved test.
Tecentriq is now the first and only cancer immunotherapy available for adjuvant treatment of NSCLC, introducing a new era where people diagnosed with early lung cancer may have the opportunity to receive immunotherapy to increase their chances for cure, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. Todays landmark approval gives physicians and patients a new way to treat early lung cancer that has the potential to significantly reduce risk of cancer recurrence, after more than a decade with limited treatment advances in this setting.
Too many patients with early-stage lung cancer experience disease recurrence following surgery. Now, the availability of immunotherapy following surgery and chemotherapy offers many patients new hope and a powerful new tool to reduce their risk of cancer relapse, said Bonnie Addario, Co-founder and Chair, GO2 Foundation for Lung Cancer. With this approval, it is more important than ever to screen for lung cancer early and test for PD-L1 at diagnosis to help bring this advance to the people who can benefit.
The approval is based on results from an interim analysis of the Phase III IMpower010 study that showed treatment with Tecentriq following surgery and platinum-based chemotherapy reduced the risk of disease recurrence or death by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88) in people with Stage II-IIIA (UICC/AJCC 7th edition) NSCLC whose tumors express PD-L11%, compared with best supportive care (BSC). Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified. Fatal and serious adverse reactions occurred in 1.8% and 18%, respectively, of patients receiving Tecentriq. The most frequent serious adverse reactions (>1%) were pneumonia (1.8%), pneumonitis (1.6%), and pyrexia (1.2%).
The review of this application was conducted under the FDAs Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners. According to the FDA, collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions. Simultaneous applications were submitted to regulators in the United States, Switzerland, the United Kingdom, Canada, Brazil and Australia under Project Orbis. Additionally, the FDA reviewed and approved the supplemental application under its Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.
Tecentriq has previously shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in the U.S. In addition to becoming the first approved cancer immunotherapy for adjuvant NSCLC, Tecentriq was also the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks.
Genentech has an extensive development program for Tecentriq, including 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 across various tumor types.
About the IMpower010 study
IMpower010 is a Phase III, global, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC/AJCC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1,005 people with a ratio of 1:1 to receive either Tecentriq for 1 year (16 cycles), unless disease recurrence or unacceptable toxicity occurred, or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA and intent-to-treat (ITT) Stage IB-IIIA populations. Key secondary endpoints include overall survival (OS) in the overall study population, ITT Stage IB-IIIA NSCLC.
About lung cancer
According to the American Cancer Society, it is estimated that more than 235,000 Americans will be diagnosed with lung cancer in 2021. NSCLC accounts for 80-85% of all lung cancers and approximately 50% of patients diagnosed with NSCLC are diagnosed with early-stage (Stages I and II) or locally advanced (Stage III) disease. Today, about half of all people with early lung cancer still experience a cancer recurrence following surgery. Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.
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 lung cancer called non-small cell lung cancer (NSCLC).
A type of lung cancer called small cell lung cancer (SCLC).
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:
Hormone gland 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:
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 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 in lung cancer
Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have five approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211015005506/en/
Read the rest here:
- Here's Why Longeveron Is Surging Today - Motley Fool - December 4th, 2021
- Global Regenerative Medicine Partnering Report/Directory 2021: Terms and Agreements for 1600 Deals 2014-2 - Benzinga - December 4th, 2021
- CAR T-Cell Therapy Market is anticipated to reach US$ 2.8 Bn by 2031 - PRNewswire - December 4th, 2021
- Stem-cell implant prototypes pave the way towards life-long treatment for type 1 diabetes - ZME Science - December 3rd, 2021
- Certain Patients With Heart Failure May Benefit From Stem Cell Therapy - Pharmacy Times - December 3rd, 2021
- Humanigen Announces Conference Call and Webcast to Discuss Lancet Respiratory Medicine Publications and Provide a Corporate Update - Yahoo Finance - December 3rd, 2021
- Roundtable Discussion: Usmani and Participants Review Using Transplant and Combination Therapy in a Patient With Newly Diagnosed Multiple Myeloma -... - December 3rd, 2021
- Hematopoiesis and innate immunity: an inseparable couple for good and bad times, bound together by an hormetic relationship - DocWire News - December 3rd, 2021
- Reality of universal cancer prevention & cure - BSA bureau - December 3rd, 2021
- World Aids Day Improving the lives of everyone affected by HIV - QMUL - December 3rd, 2021
- Seres Therapeutics Announces First Patient Enrolled in Phase 1b Study of SER-155, an Investigational Microbiome Therapeutic to Reduce the Risk of... - December 3rd, 2021
- AVROBIO Presents Clinician Experience with FAB-GT Clinical Trial and Updated Safety Data for Investigational Gene Therapies in Fabry Disease and... - November 28th, 2021
- The questions surgical robots still need to answer - Becker's Orthopedic & Spine - November 24th, 2021
- Holiday Gift Guide 2021: The Best Wellness And Self-Care Essentials For Travel - Forbes - November 24th, 2021
- Investigating pathogens and their life cycles, for the benefit of society - MIT News - November 24th, 2021
- Mitigating Toxicities Will Position BCMA for Role in Triple-Class Refractory Multiple Myeloma - OncLive - November 24th, 2021
- Human Primary Cells Market 2021 | Know the Latest COVID19 Impact Analysis and Strategies of Key Players: Lonza, Thermo Fisher Scientific,... - November 21st, 2021
- Researcher Works for Diversity, Inclusion in Sciences, One Journal at a Time - Lab Manager Magazine - November 18th, 2021
- Raw Marijuana Won't Get You Stoned, But It Does Have Some Interesting Benefits - Benzinga - Benzinga - November 16th, 2021
- The 18 Best New November 2021 Skin-Care Launches That Deserve a Spot in Your Routine - Allure - November 16th, 2021
- Singapore Aims To Lead The World In Lab-Grown Meat - Intelligent Living - November 16th, 2021
- Dermarolling Your Scalp Is Proven to Increase Hair Growth and Thickness Here's How to Do It - Yahoo Lifestyle - November 15th, 2021
- Stem Cell Therapy for Heart Failure Reduces CV Events, Death in Select Patientsbut not Hospitalization - AJMC.com Managed Markets Network - November 15th, 2021
- JASPER THERAPEUTICS, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) - marketscreener.com - November 15th, 2021
- Week In Review: Zai Lab Announces Two In-Licensings With Total Value Of $800 Million - Seeking Alpha - November 15th, 2021
- Beam gets green light to begin first clinical test of base editing - BioPharma Dive - November 15th, 2021
- GlycoMimetics GMI-1359 Data Selected for Presentation at 63rd American Society of Hematology (ASH) Annual Meeting and Exposition - Galveston County... - November 15th, 2021
- Jasper Therapeutics to Present at the Credit Suisse 30th Annual Virtual Healthcare Conference - GlobeNewswire - November 11th, 2021
- Biotech Companies are Expanding the Frontiers of Engineered Cell Therapy - BioSpace - November 11th, 2021
- Fate Therapeutics Announces Abstract Highlighting FT538 and - GlobeNewswire - November 11th, 2021
- Poseida Therapeutics to Present Preclinical Data Highlighting Fully Allogeneic CAR-T Product Candidates at the Society for Immunotherapy of Cancer... - November 11th, 2021
- Affimed Reports Third Quarter 2021 Financial Results and Highlights Operational Progress - KULR-TV - November 11th, 2021
- Jasper Therapeutics to Present at the Credit Suisse 30th Annual Virtual Healthcare Conference - Yahoo Finance - November 9th, 2021
- CELLECTAR BIOSCIENCES, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) - marketscreener.com - November 9th, 2021
- Hoth Therapeutics Inks API and Drug Product Contracts with WuXi STA to Advance Manufacturing of HT-KIT Cancer Therapeutic - PRNewswire - November 9th, 2021
- Technology set to redesign the future of food as agriculture moves towards net zero - ABC News - November 9th, 2021
- MAGENTA THERAPEUTICS, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q) - marketscreener.com - November 5th, 2021
- Magenta Therapeutics Announces Data Presentations Related to its Mobilization and Conditioning Programs at the 2021 American Society of Hematology... - November 5th, 2021
- 15 Best Peptide Skin-Care Products 2021 for Smoother, Firmer, and Plumper Skin - Allure - November 5th, 2021
- Atara Biotherapeutics to Present Eight Abstracts at the 63rd American Society of Hematology (ASH) Annual Meeting, Including First Presentation of... - November 5th, 2021
- CRISPR Therapeutics Provides Business Update and Reports Third Quarter 2021 Financial Results - GlobeNewswire - November 5th, 2021
- Fate Therapeutics Announces Eight Presentations at the 2021 ASH Annual Meeting - The Bakersfield Californian - November 5th, 2021
- STEMTECH CORPORATION (OTC:GNTW) ANNOUNCES APPOINTMENT OF SANDRA KAZICKAITE TO THE ROLE OF VICE PRESIDENT OF GLOBAL PERFORMANCE - Yahoo Finance - November 3rd, 2021
- Assessing the benefits of stem cell research (column) - LNP | LancasterOnline - November 1st, 2021
- How to Test for Leukemia: What Are My Options? - Healthline - November 1st, 2021
- Exposed: The Plague Of Fake Medical Trials Putting Lives In Danger - Todayuknews - Todayuknews - November 1st, 2021
- To Reduce Stress and Boost Energy, Try Maca Root - The Beet - November 1st, 2021
- In Vitro Toxicology Testing Market Outlook 2021 Pricing Strategy, Industry Latest News, Top Company Analysis, Research Report Analysis and Share by... - November 1st, 2021
- Geron Enters New Innovative Licensing and Access Pathway in the United Kingdom for Imetelstat - Business Wire - November 1st, 2021
- Stem Cell Diseases: What Can Stem Cells Cure | stemcela.com - October 30th, 2021
- The Cost Of Stem Cell Therapy in 2021 | BioInformant - October 30th, 2021
- NIH Guidelines for Human Stem Cell Research | STEM Cell ... - October 30th, 2021
- Fi Europe 2021 innovation finalists mirror mega trends of plant based and sustainability - FoodNavigator.com - October 30th, 2021
- Types of Oncology Drugs - Healthline - October 28th, 2021
- Medical Innovation In Pet Healthcare Is Taking Things Up a Notch - Entrepreneur - October 28th, 2021
- BIOHAVEN ENROLLS PHASE 1A/1B CLINICAL TRIAL OF BHV-1100, LEAD ASSET FROM ITS ARM (ANTIBODY RECRUITING MOLECULE) PLATFORM, IN COMBINATION WITH NK CELL... - October 28th, 2021
- Researchers discover a way to increase the effectiveness of antibiotics - EurekAlert - October 28th, 2021
- Fresh Bros: Exploring the Top Five Health Benefits of Turmeric Extract with BioPerine - GlobeNewswire - October 28th, 2021
- All hopes to save the northern white rhinos now rest on a single female - ZME Science - October 23rd, 2021
- AVROBIO Reports New Interim Safety Data Across Investigational Gene Therapies for Fabry and Gaucher Disease Type 1 - StreetInsider.com - October 21st, 2021
- CDMO: The Rise of End-to-End Services - Marketscreener.com - October 21st, 2021
- MeiraGTx Announces the Presentation of Two Novel Inherited - GlobeNewswire - October 21st, 2021
- Current status of drug repositioning in hematology - DocWire News - October 19th, 2021
- Is Fresh Breast Milk Better for Preemies Than Pumped and Stored? - UMass News and Media Relations - October 19th, 2021
- Vertex Announces Positive Day 90 Data for the First Patient in the Phase 1/2 Clinical Trial Dosed With VX-880, a Novel Investigational Stem... - October 19th, 2021
- Headband Could Beat Insomnia By Zapping The Brain While Sufferers Wear It For 20 Minutes At Bedtime - - Todayuknews - October 19th, 2021
- BioLineRx Announces Positive Results from Pharmacoeconomic Study Positioning Motixafortide as Potential Standard of Care in Stem Cell Mobilization -... - October 17th, 2021
- Misinformation on stem cell treatments for COVID-19 linked to overhyped science, researchers argue - EurekAlert - October 17th, 2021
- Nic Chapman: my MS battle and the treatment that's given me hope - The Times - October 17th, 2021
- Dream Body Clinic Stem Cell Therapy Stem Cells HGH - October 13th, 2021
- Hematopoietic Stem Cells - October 13th, 2021
- 3D printing: Healthcare insiders' view on the tech - Verdict - October 13th, 2021
- Top 10 Best Stem Cell Supplement Brands - Healthtrends - October 13th, 2021
- Mitochondrial superoxide dismutase overexpression and low oxygen conditioning hormesis improve the performance of irradiated sterile males |... - October 13th, 2021
- Researchers uncover how cancer cells use sugar residue to evade the immune system - News-Medical.net - October 13th, 2021
- The science and practicality of cultured meat The Stute - The Stute - October 11th, 2021
- Vitro Biopharma Inc. July 31st 2021; 3rd Quarter ended Financial Results of Operations and Shareholder Le - Benzinga - October 11th, 2021
- Want To Support Healthy Bones? It's Time To Get Your Vitamin D In Check - mindbodygreen.com - October 11th, 2021
- Joint : Why Breast Cancer Awareness Matters, and How to Get It Done - marketscreener.com - October 11th, 2021
- Faster healing of wounds can decrease pain and suffering and save lives - KY3 - October 7th, 2021