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Title Tecentriq (atezolizumab) FDA Drug Label
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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
Drug Name Trade Name Synonyms Drug Classes Drug Description
Atezolizumab Tecentriq RG7446|MPDL3280A Immune Checkpoint Inhibitor 94 PD-L1/PD-1 antibody 63 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 advanced or metastatic urothelial carcinoma not eligible for cisplatin-containing chemotherapy, in advanced or metastatic urothelial carcinoma not eligible for chemotherapy or progressed on platinum-based 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, 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 paclitaxel protein-bound in advanced or metastatic triple-negative breast cancer expressing PD-L1, in combination with carboplatin and etoposide in extensive-stage small cell lung cancer, in combination with bevacizumab in hepatocellular carcinoma without prior systemic therapy, and in combination with cobimetinib and vemurafenib in BRAF V600-mutated melanoma (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...
Unknown unknown hepatocellular carcinoma not applicable Atezolizumab + Bevacizumab FDA approved Actionable In a Phase III trial (IMbrave150) that supported FDA approval, Tecentriq (atezolizumab) and Avastin (bevacizumab) combination therapy improved survival compared to Nexavar (sorafenib) (HR for death=0.58, p<0.001) in patients with unresectable hepatocellular carcinoma, with superior overall survival at 12 months (67.2% vs 54.6%) and prolonged median progression-free survival (6.8 vs 4.3 months, HR=0.59, p<0.001) (PMID: 32402160; NCT03434379). detail... 32402160
Unknown unknown transitional cell carcinoma not applicable Atezolizumab FDA approved Actionable In a Phase II trial that supported FDA approval, treatment with Tecentriq (atezolizumab) in advanced urothelial carcinoma patients resulted in an objective response rate of 15% (45/310) in all patients, and 26% (26/100) in patients with immune cell PD-L1 expression greater than or equal to 5%, and resulted in an overall survival of 8.6 mo in patients receiving treatment post-progression compared to 1.2 mo in patients receiving no treatment post-progression (PMID: 26952546, PMID: 28950298; NCT02108652). 26952546 28950298 detail...
Unknown unknown lung non-small cell carcinoma not applicable Atezolizumab FDA approved Actionable In a Phase III trial (OAK) that supported FDA approval, treatment with Tecentriq (atezolizumab) resulted in an improved median overall survival compared to Taxotere (docetaxel) (13.8 vs 9.6 months, HR=0.73, p=0.0003) in patients with previously treated non-small cell lung cancer (PMID: 27979383; NCT02008227). detail... 27979383
Unknown unknown lung small cell carcinoma not applicable Atezolizumab + Carboplatin + Etoposide FDA approved Actionable In a Phase III trial (IMpower133) that supported FDA approval, Tecentriq (atezolizumab) in combination with Paraplatin (carboplatin) and Vepesid (etoposide) resulted in significantly improved median overall survival (12.3 vs 10.3 months, HR=0.70, p=0.007) and median progression-free survival (5.2 vs 4.3 months, HR=0.77, p=0.02) compared to placebo in patients with untreated extensive-stage small-cell lung cancer (PMID: 30280641; NCT02763579). detail... 30280641