Atezolizumab

PD L1 may be expressed on tumor cells and/or tumor infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD L1 to the PD 1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine production.

• TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: Non-Small Cell Lung Cancer (NSCLC) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-authorized test. ( 1.1 , 14.1 ) for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%] ), as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations.ICD-10: C34.90

• None. None.contraindicated

Administer TECENTRIQ intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. NSCLC In the adjuvant setting, administer TECENTRIQ following resection and up to 4 cycles of platinum-based chemotherapy as 840 mg every 2 weeks, 1200 mg every 3 weeks or 1680 mg every 4 weeks for up to 1 year. ( 2.2 ) In the metastatic setting, administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. ( 2.2 ) When administering with chemotherapy with or without bevacizumab, administer TECENTRIQ prior to chemotherapy and bevacizumab when given on the same day. ( 2.2 ) Small Cell Lung Cancer Administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. Administer TECENTRIQ prior to chemotherapy when given on the same day. ( 2.2 ) Hepatocellular Carcinoma Administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks. Administer TECENTRIQ prior to bevacizumab when given on the same day. Bevacizumab is administered at 15 mg/kg every 3 weeks. ( 2.2 ) Melanoma Following completion of a 28-day cycle of cobimetinib and vemurafenib, administer TECENTRIQ 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks with cobimetinib 60 mg orally once daily (21 days on /7 days off) and vemurafenib 720 mg orally twice daily. ( 2.2 ) ASPS Adults: Administer TECENTRIQ as 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks.

Immune-Mediated Adverse Reactions Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection. ( 5.1 ) Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. ( 5.1 ) Withhold or permanently discontinue based on severity and type of reaction. ( 5.1 ). Infusion-Related Reactions : Interrupt, slow the rate of infusion, or permanently discontinue based on severity of infusion reactions. ( 5.2 ) Complications of Allogeneic HSCT: Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. ( 5.3 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Severe and Fatal Immune-Mediated Adverse Reactions TECENTRIQ is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death-receptor 1 (PD-1) or the PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions.

The following clinically significant adverse reactions are described elsewhere in the labeling: Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ] Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Complications of Allogeneic HSCT after PD-1/PD-L1 Inhibitors [see Warnings and Precautions (5.3) ] TECENTRIQ as a single-agent Most common adverse reactions (≥ 20%) with TECENTRIQ as a single-agent are fatigue/asthenia, decreased appetite, nausea, cough, and dyspnea. ( 6.1 ) TECENTRIQ in combination with other antineoplastic drugs Most common adverse reactions (≥ 20%) in patients with NSCLC and SCLC are fatigue/asthenia, nausea, alopecia, constipation, diarrhea, and decreased appetite. ( 6.1 ) TECENTRIQ in combination with bevacizumab Most common adverse reactions (≥ 20%) in patients with HCC are hypertension, fatigue and proteinuria. ( 6.1 ) TECENTRIQ in combination with cobimetinib and vemurafenib Most common adverse reactions (≥ 20%) with TECENTRIQ in patients with melanoma are rash, musculoskeletal pain, fatigue, hepatotoxicity, pyrexia, nausea, pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action [see Clinical Pharmacology (12.1) ] , TECENTRIQ can cause fetal harm when administered to a pregnant woman. There are no available data on the use of TECENTRIQ in pregnant women. Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to increased risk of immune-related rejection of the developing fetus resulting in fetal death (see Data ) . Advise females of reproductive potential of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with TECENTRIQ to evaluate its effect on reproduction and fetal development. A literature-based assessment of the effects on reproduction demonstrated that a central function of the PD-L1/PD-1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to a fetus. Blockage of PD-L1 signaling has been shown in murine models of pregnancy to disrupt tolerance to a fetus and to result in an increase in fetal loss; therefore, potential risks of administering TECENTRIQ during pregnancy include increased rates of abortion or stillbirth.

Metabolism

Atezolizumab exposure increased dose proportionally over the dose range of 1 mg/kg to 20 mg/kg (0.07 to 1.33 times of the approved recommended doses), including a dose of 1200 mg administered every 3 weeks. Steady state was achieved after 6 to 9 weeks following multiple doses.

• May 18, 2016BLABLA761034Genentech Inc
• Sep 12, 2024BLABLA761347Genentech Inc

1. 1Death4,16711%
2. 2Off Label Use3,4259.1%
3. 3Disease Progression2,0765.5%
4. 4Pyrexia1,7124.6%
5. 5Diarrhoea1,6814.5%
6. 6Fatigue1,4513.9%
7. 7Anaemia1,3083.5%
8. 8Pneumonia1,0992.9%
9. 9Decreased Appetite1,0772.9%
10. 10Nausea1,0342.8%
11. 11Hypothyroidism1,0272.7%
12. 12Dyspnoea1,0002.7%
13. 13Hypertension9712.6%
14. 14Pneumonitis9342.5%
15. 15Febrile Neutropenia9292.5%

The 10 most recently updated of 988 ClinicalTrials.gov registrations naming Atezolizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
  Recruiting · Phase 2 · Phase 3 · Interventional · 189 enrolled · National Cancer Institute (NCI)
  NCT05058651updated 2026-06-12
• A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study
  Recruiting · Phase 3 · Interventional · 100 enrolled · Hoffmann-La Roche
  NCT05862285updated 2026-06-12
• A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)
  Recruiting · Phase 1 · Phase 2 · Interventional · 170 enrolled · Merck Sharp & Dohme LLC
  NCT07227597updated 2026-06-12
• A Real-world Study of Immunotherapy Combination Regimens for Treating Liver Cancer in Cold Regions
  Active not recruiting · Observational · 1,000 enrolled · Harbin Medical University
  NCT07645209updated 2026-06-12
• Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer
  Recruiting · Phase 2 · Phase 3 · Interventional · 613 enrolled · National Cancer Institute (NCI)
  NCT01810913updated 2026-06-12
• Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, The AXIOM Trial
  Recruiting · Phase 2 · Interventional · 27 enrolled · National Cancer Institute (NCI)
  NCT05333458updated 2026-06-12
• Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma
  Recruiting · Phase 1 · Phase 2 · Interventional · 6 enrolled · M.D. Anderson Cancer Center
  NCT05039281updated 2026-06-11
• Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer
  Active not recruiting · Phase 3 · Interventional · 415 enrolled · National Cancer Institute (NCI)
  NCT04214262updated 2026-06-11
• Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial
  Recruiting · Phase 2 · Phase 3 · Interventional · 138 enrolled · National Cancer Institute (NCI)
  NCT04402788updated 2026-06-11
• NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
  Terminated · Phase 2 · Interventional · 33 enrolled · NeoImmuneTech
  NCT04984811updated 2026-06-11

Frequently asked questions

How does Atezolizumab work?

PD L1 may be expressed on tumor cells and/or tumor infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD L1 to the PD 1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine production.

What is Atezolizumab used for?

According to FDA labeling, Atezolizumab carries indications including: TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: Non-Small Cell Lung Cancer (NSCLC) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-authorized test. ( 1.1 , 14.1 ) for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%] ), as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Atezolizumab?

Atezolizumab is classified as PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors, Programmed Death Receptor-1 Blocking Antibody, Programmed Death Receptor-1-directed Antibody Interactions, Increased Immunologic Activity.

What are the brand names for Atezolizumab?

Atezolizumab is marketed under brand names including Tecentriq, Tecentriq Hybreza.

What are the contraindications for Atezolizumab?

Atezolizumab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.