Drug name | Tecentriq®
|
INN | Atezolizumab |
API type | humanized IgG1 |
Pharmacotherapeutic group
| Antineoplastic agents, monoclonal antibodies
|
ATC code
| L01XC32 |
Target of antibody
| PD-L1; Synonyms: CD274, B7-H, B7H1, PD-L1, PDCD1L1, PDCD1LG1, PDL1, A530045L16Rik, B7h1, Pdcd1l1,
Pdcd1lg1, Pdl1, RGD1566211 |
General function | Atezolizumab works by attaching to a specific protein in your body called programmed death-ligand 1 (PD-L1). This protein suppresses the body’s immune (defense) system, thereby protecting cancer cells from being attacked by the immune cells. By attaching to the protein, Atezolizumab helps your immune system to fight your cancer. |
Short description | Atezolizumab is an Fc-engineered, humanised IgG1 anti-programmed death-ligand 1 (PD-L1) monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology
|
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
| Programmed death-ligand 1 (PD-L1) may be expressed on tumour cells and/or tumour-infiltrating immune cells, and can contribute to the inhibition of the antitumour immune response in the tumour
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 an Fc-engineered, humanised immunoglobulin G1 (IgG1) monoclonal antibody that directly binds to PD-L1 and provides a dual blockade of the PD-1 and B7.1 receptors, releasing
PD-L1/PD-1 mediated inhibition of the immune response, including reactivating the antitumour immune response without inducing antibody-dependent cellular cytotoxicity. Atezolizumab spares the PD-L2/PD-1 interaction allowing PD-L2/PD-1 mediated inhibitory signals to persist. |
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Atezolizumab is a Antineoplastic agent, with an Fc-engineered, humanized immunoglobulin G1 (IgG1) monoclonal antibody that directly binds to PD-L1 and provides a dual blockade of the PD-1 and B7.1 receptors, releasing
PD-L1/PD-1 mediated inhibition of the immune response, including reactivating the antitumor immune response without inducing antibody-dependent cellular cytotoxicity.
Atezolizumab spares the PD-L2/PD-1 interaction allowing PD-L2/PD-1 mediated inhibitory signals to persist |
Original license holder
| Roche Registration GmbH |
Marketing authorisation numbers
| EU/1/17/1220/002 |
Marketing authorisation holder
| Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
(Date of first authorisation: 21 September 2017) |
Name of the manufacturer of the biological active substance
| F. Hoffmann-La Roche AG
Grenzacherstrasse 124
4070 Basel
SWITZERLAND |
Name and address of the manufacturer(s) responsible for batch release | Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Whylen
GERMANY |
Max shelf life
| 36 months
|
Storage conditions
| 2°C – 8°C
|
List of excipients
| L-histidine
Glacial acetic acid
Sucrose
Polysorbate 20 |
| |
| |