Tecentriq Approval History

• FDA approved: Yes (First approved May 18th, 2016)
• Brand name: Tecentriq
• Generic name: atezolizumab
• Dosage form: Injection
• Company: Genentech, Inc.
• Treatment for: Bladder Cancer, Non-Small Cell Lung Cancer

Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with advanced urothelial carcinoma and patients with metastatic non-small cell lung cancer (NSCLC).

Tecentriq is administered via intravenous infusion over 60 minutes every 3 weeks. Patients should be aware that Tecentriq has the potential to cause infection and severe immune-mediated side effects that involve healthy organs. In some cases, treatment may need to be interrupted or discontinued, and corticosteroid treatment may be required.

The most common side effects reported in patients with advanced urothelial carcinoma were fatigue, decreased appetite, nausea, urinary tract infection, fever, and constipation. The most common side effects reported in patients with metastatic non-small cell lung cancer were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation.

Development History and FDA Approval Process for Tecentriq

Date	Article
Apr 17, 2017	FDA Grants Genentech’s Tecentriq (atezolizumab) Accelerated Approval as Initial Treatment for Certain People with Advanced Bladder Cancer
Oct 18, 2016	FDA Approves Genentech’s Cancer Immunotherapy Tecentriq (Atezolizumab) for People with a Specific Type of Metastatic Lung Cancer
May 18, 2016	FDA Approves Tecentriq (atezolizumab) for Urothelial Carcinoma
Apr 10, 2016	FDA Grants Priority Review for Genentech’s Cancer Immunotherapy Atezolizumab in Specific Type of Lung Cancer
Mar 14, 2016	FDA Grants Genentech’s Cancer Immunotherapy Atezolizumab Priority Review for Advanced Bladder Cancer
Jan  8, 2016	Roche Presents Updated Results for Investigational Cancer Immunotherapy Atezolizumab in Advanced Bladder Cancer
Aug 26, 2015	Syndax Enters Clinical Trial Collaboration In Cancer Immunotherapy Combining Entinostat and Atezolizumab
Aug 16, 2015	Pivotal Phase II Study Showed Atezolizumab Shrank Tumors in People with a Specific Type of Lung Cancer
Jul 12, 2015	In a Pivotal Study, Genentech’s Investigational Immunotherapy Atezolizumab Shrank Tumors in People With a Specific Type of Bladder Cancer

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