Overview
Atezolizumab is a humanized monoclonal antibody used to prevent the interaction of PD-L1 and PD-1, removing inhibition of immune responses seen in some cancers. This medication is reserved for patients whose tumors express PD-L1, cannot receive platinum-based chemotherapy, or whose tumors do not respond to platinum-based chemotherapy. Atezolizumab was granted FDA approval on 18 October 2016. In November 2022, the manufacturer (Genentech) voluntarily withdrew the use of atezolizumab for the treatment of urothelial carcinoma, previously approved under the FDA's Accelerated Approval Program. The rest of atezolizumab indications remain unaffected.
Background
Atezolizumab is a humanized monoclonal antibody used to prevent the interaction of PD-L1 and PD-1, removing inhibition of immune responses seen in some cancers. This medication is reserved for patients whose tumors express PD-L1, cannot receive platinum-based chemotherapy, or whose tumors do not respond to platinum-based chemotherapy. Atezolizumab was granted FDA approval on 18 October 2016. In November 2022, the manufacturer (Genentech) voluntarily withdrew the use of atezolizumab for the treatment of urothelial carcinoma, previously approved under the FDA's Accelerated Approval Program. The rest of atezolizumab indications remain unaffected.
Indication
Atezolizumab has approved indications for the following conditions: Non-Small Cell Lung Cancer (NSCLC) Small Cell Lung Cancer (SCLC) Hepatocellular Carcinoma (HCC) Melanoma Alveolar Soft Part Sarcoma (ASPS)
Associated Conditions
- Metastatic Alveolar Soft Part Sarcoma
- Metastatic Hepatocellular Carcinoma
- Metastatic Melanoma
- Metastatic Non-Small Cell Lung Cancer
- Metastatic Non-squamous Non Small Cell Lung Cancer
- Non-Small Cell Lung Carcinoma
- Nonsmall Cell Lung Cancer, Stage II
- Small Cell Lung Cancer (SCLC)
- Stage IIIA Non Small Cell Lung Cancer
- Triple-Negative Breast Cancer
- Unresectable Alveolar Soft Part Sarcoma
- Unresectable Hepatocellular Carcinoma (HCC)
- Unresectable Melanoma
Research Report
Atezolizumab (Tecentriq®/Tecentriq Hybreza™): A Comprehensive Oncological Review
1. Introduction to Atezolizumab (Tecentriq®/Tecentriq Hybreza™)
Atezolizumab is a humanized monoclonal antibody that functions as an immune checkpoint inhibitor by targeting Programmed Death-Ligand 1 (PD-L1).[1] As an antineoplastic agent, Atezolizumab belongs to the therapeutic class of anti-PD-L1 monoclonal antibodies.[5] Its clinical significance lies in its ability to modulate the host immune response against tumor cells, representing a pivotal advancement in cancer therapy.[6] Developed by Genentech, a member of the Roche Group, Atezolizumab has become a cornerstone in the treatment of various malignancies.[6] The medication is available in an intravenous formulation (Tecentriq®) and a subcutaneous formulation (Tecentriq Hybreza™), the latter co-formulated with hyaluronidase to facilitate subcutaneous delivery.[8]
The development and expanding applications of Atezolizumab exemplify the transformative shift in oncology towards immunotherapy, which harnesses the body's immune system to combat cancer. This approach targets key immune escape pathways exploited by tumors. The approval of Atezolizumab across a diverse range of cancer types, often in settings where previous therapeutic options offered limited efficacy, signifies a paradigm shift in cancer treatment strategies. Its progression from use in later lines of therapy to first-line and adjuvant settings further underscores its integral role in contemporary oncological practice.[7] This report aims to provide a comprehensive review of Atezolizumab, encompassing its pharmacological characteristics, detailed regulatory history with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), extensive clinical trial data supporting its efficacy and safety, and its current clinical applications.
2. Chemical, Pharmaceutical, and Manufacturing Characteristics
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/13 | Phase 2 | Not yet recruiting | Fundacion Clinic per a la Recerca Biomédica | ||
2025/04/22 | Phase 1 | Recruiting | |||
2025/04/10 | Phase 3 | Recruiting | |||
2025/04/03 | Phase 3 | Not yet recruiting | Intergroupe Francophone de Cancerologie Thoracique | ||
2025/03/27 | Phase 1 | Recruiting | |||
2025/03/25 | Phase 2 | Not yet recruiting | |||
2025/03/25 | N/A | Recruiting | Shanghai Pulmonary Hospital, Shanghai, China | ||
2025/02/04 | Phase 1 | Recruiting | |||
2025/01/23 | Phase 2 | Recruiting | |||
2025/01/20 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Genentech, Inc. | 50242-917 | INTRAVENOUS | 1200 mg in 20 mL | 4/30/2023 | |
Genentech, Inc. | 50242-918 | INTRAVENOUS | 840 mg in 14 mL | 4/30/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 9/20/2017 | ||
Authorised | 9/20/2017 | ||
Authorised | 9/20/2017 | ||
Authorised | 9/20/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 840MG/14ML | SIN15964P | INFUSION, SOLUTION CONCENTRATE | 840mg/14ml | 6/25/2020 | |
TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 1200 MG/ 20 ML | SIN15425P | INFUSION, SOLUTION CONCENTRATE | 1200 mg | 2/9/2018 | |
TECENTRIQ SOLUTION FOR INJECTION 1875MG/15ML | SIN17033P | INJECTION, SOLUTION | 1875 mg/15ml | 6/27/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Atezolizumab Injection | 国药准字SJ20200004 | 生物制品 | 注射剂 | 10/29/2024 | |
Atezolizumab Injection | S20200004 | 生物制品 | 注射剂 | 2/11/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 1200MG/20ML | N/A | N/A | N/A | 1/29/2018 | |
TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 840MG/14ML | N/A | N/A | N/A | 3/30/2020 | |
TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 1200MG/20ML | N/A | N/A | N/A | 8/26/2019 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
TECENTRIQ SC atezolizumab 1875 mg/15 mL solution for injection vial | 400555 | Medicine | A | 2/29/2024 | |
TECENTRIQ atezolizumab (rch) 1200 mg/20 mL injection concentrated vial | 277120 | Medicine | A | 7/27/2017 | |
TECENTRIQ atezolizumab (rch) 840 mg/14 mL injection concentrated vial | 310681 | Medicine | A | 7/31/2019 |