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PMID
Authors
Title Tecentriq (atezolizumab) FDA Drug Label
Journal Vol Issue Date Pages Journal Short Title
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761034
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Atezolizumab Atezolizumab 7 163
Drug Name Trade Name Synonyms Drug Classes Drug Description
Atezolizumab Tecentriq RG7446|MPDL3280A Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 Tecentriq (atezolizumab) is a monoclonal antibody against PD-L1 (CD274), preventing activation of its receptor, potentially enhancing T-cell-mediated immune response to neoplasms and inhibiting T-cell inactivation (PMID: 29449897). Tecentriq (atezolizumab) is FDA approved for use in PD-L1 positive (IC >/= 5%) advanced or metastatic urothelial carcinoma not eligible for cisplatin-containing chemotherapy, in advanced or metastatic urothelial carcinoma not eligible for chemotherapy, in metastatic non-small cell lung cancer (NSCLC) progressed on platinum-containing therapy, as first-line therapy in metastatic NSCLC with high PD-L1 expression (TC>/=50% or IC>/=10%) and without EGFR or ALK alterations, for adjuvant treatment in patients with PD-L1-positive (>=1% tumor cell expression) NSCLC, in combination with bevacizumab, paclitaxel, and carboplatin as first-line therapy for non-squamous NSCLC with no EGFR or ALK aberrations, in combination with paclitaxel protein-bound and carboplatin in metastatic non-squamous NSCLC with no EGFR or ALK aberrations, in combination with carboplatin and etoposide in extensive-stage small cell lung cancer, in combination with bevacizumab in hepatocellular carcinoma without prior systemic therapy, in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) in unresectable or metastatic BRAF V600-mutated melanoma, and in pediatric and adult patients with unresectable or metastatic alveolar soft part sarcoma (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF V600X melanoma sensitive Atezolizumab + Cobimetinib + Vemurafenib FDA approved Actionable In a Phase III trial (IMspire150) that supported FDA approval, addition of Tecentriq (atezolizumab) to Zelboraf (vemurafenib) and Cotellic (cobimetinib) combination therapy significantly improved progression-free survival (15.1 vs 10.6 months, HR=0.78, p=0.025) compared to control in patients with advanced or metastatic melanoma harboring BRAF V600 mutations (PMID: 32534646; NCT02908672). 32534646 detail...