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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 7 169
Drug Name Trade Name Synonyms Drug Classes Drug Description
Atezolizumab Tecentriq RG7446|MPDL3280A Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 132 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 cisplatin ineligible urothelial carcinoma, 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 PD-L1-high (TC>/=50% or IC>/=10%) NSCL 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 (ES-SCLC), 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, in combination with lurbinectedin for ES-SCLC, 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...