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
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2020/06/11 | Phase 2 | Completed | |||
2020/06/09 | Phase 1 | Terminated | |||
2020/06/09 | Phase 2 | Recruiting | |||
2020/05/29 | Phase 2 | Completed | MedSIR | ||
2020/05/27 | Phase 1 | Terminated | |||
2020/05/27 | Phase 2 | Recruiting | |||
2020/05/13 | Phase 1 | Active, not recruiting | |||
2020/05/04 | Phase 2 | Active, not recruiting | |||
2020/04/29 | Phase 2 | Recruiting | |||
2020/04/22 | Phase 2 | Active, not recruiting | Elizabeth Buchbinder, MD |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |