Atezolizumab was approved by the U.S. Food and Drug Administration (FDA) on May 18, 2016. It was developed and marketed as Tecentriq® by Genentech (a member of Roche).
Atezolizumab is a programmed cell death-Ligand (PD-L1) blocker, which binds to PD-L1 and blocks its interactions with both PD-1 and B7.1 receptors, releasing the PD-L1/PD-1 mediated inhibition of the immune response. It is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before (neoadjuvant) or after (adjuvant) surgical treatment.
Tecentriq® is available as injection for intravenous infusion, containing 1200 mg of atezolizumab in 20 mL solution in a single-dose vial. The recommended dose is 1200 mg taken over 60 minutes every 3 weeks.
Update Date:2016-05-19
Update Date:2016-05-19
Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
---|---|---|---|---|---|---|---|
2016-05-18 | First approval | Tecentriq | Urothelial cancer | Injection, Solution | 1200 mg/20 mL | Genentech, Roche | Priority |
Update Date:2016-05-19
Type | Whole antibody | |
Source | Humanized | |
Molecular Formula | C6446H9902N1706O1998S42 | |
Molecular Weight | ~145000 | |
CAS No. | 1380723-44-3 | |
Expression System | Mammalian Cell |