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Clinical pharmacology

Initial U.S. Approval:  2016

Mechanism of Action:
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.

Atezolizumab is a monoclonal antibody that binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors. This releases the PD-L1/PD-1 mediated inhibition of the immune response, including activation of the anti-tumor immune response without inducing antibody-dependent cellular cytotoxicity. In syngeneic mouse tumor models, blocking PD-L1 activity resulted in decreased tumor growth.

Indications and usage 

INDICATIONS AND USAGE:
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

-Have disease progression during or following platinum-containing chemotherapy (1)
-Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy (1)

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1, 14)

Dosage and administration 

 TECENTRIQ™ (atezolizumab) injection
[Drug information  /  PDF]  
Package insert - Dosing:  Click (+) next to Dosage and Administration section (drug info link)

DOSAGE AND ADMINISTRATION
Administer 1200 mg as an intravenous infusion over 60 minutes every 3 weeks.
Dilute prior to intravenous infusion.

How supplied

HOW SUPPLIED:
DOSAGE FORMS AND STRENGTHS
Injection: 1200 mg/20 mL (60 mg/mL) solution in a single-dose vial

Reference

 TECENTRIQ™ (atezolizumab) injection
[Drug information  /  PDF]  
Package insert - Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

TECENTRIQ™ (atezolizumab) injection prescribing information

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