MedPath

Atezolizumab

Generic Name
Atezolizumab
Brand Names
Tecentriq
Drug Type
Biotech
CAS Number
1380723-44-3
Unique Ingredient Identifier
52CMI0WC3Y

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

Published: May 23, 2025

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

Continue reading the full research report

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

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
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