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Title Tecentriq (atezolizumab) FDA Drug Label
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 26 151
Drug Name Trade Name Synonyms Drug Classes Drug Description
Atezolizumab Tecentriq RG7446|MPDL3280A Immune Checkpoint Inhibitor 147 PD-L1/PD-1 antibody 117 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
CD274 positive transitional cell carcinoma sensitive Atezolizumab FDA approved - On Companion Diagnostic Actionable In a Phase II trial (IMvigor210) that supported FDA approval, treatment with Tecentriq (atezolizumab) resulted in an objective response rate (ORR) of 23% (27/119) in cisplatin-ineligible patients with previously untreated, locally advanced or metastatic urothelial cancer, and ORR was 28% (9/32, 4 complete responses, 5 partial responses) in patients with immune cell CD274 (PD-L1) expression greater than or equal to 5% (PMID: 27939400; NCT02108652). detail... 27939400 detail...
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...
CD274 positive bladder urothelial carcinoma sensitive Atezolizumab FDA approved - On Companion Diagnostic Actionable In a Phase II trial (IMvigor210) that supported FDA approval, treatment with Tecentriq (atezolizumab) resulted in an objective response rate (ORR) of 23% (27/119) in cisplatin-ineligible patients with previously untreated, locally advanced or metastatic urothelial cancer, and ORR was 28% (9/32, 4 complete responses, 5 partial responses) in patients with immune cell CD274 (PD-L1) expression greater than or equal to 5% (PMID: 27939400; NCT02108652). detail... detail... 27939400
CD274 positive triple-receptor negative breast cancer sensitive Atezolizumab + Nab-paclitaxel Phase III Actionable In a Phase III trial (IMpassion130), Tecentriq (atezolizumab) in combination with Abraxane (nab-paclitaxel) resulted in improved progression-free survival (7.5 vs 5.0 months, HR=0.62, p<0.001) and overall survival (25.0 vs 15.5 months, HR=0.62) compared to placebo in patients with CD274 (PD-L1)-positive (>1%), advanced triple-receptor negative breast cancer (PMID: 30345906; NCT02425891). detail... 30345906 detail...
CD274 positive lung non-small cell carcinoma sensitive Atezolizumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (IMpower010) that supported FDA approval, adjuvant Tecentriq (atezolizumab) treatment following resection and chemotherapy improved disease-free survival compared to best supportive care (HR 0·66, p=0·0039) in patients with stage II-IIIA non-small cell lung cancer whose tumors expressed CD274 (PD-L1) on 1% or more of tumor cells (PMID: 34555333; NCT02486718). detail... 34555333 detail...