Tecentriq (atezolizumab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Genentech, Inc. Tecentriq (atezolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761034s053lbl.pdf. Revised April 2024. Accessed October 30, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on >= 1% of tumor cells, as determined by an FDA-approved test.	1
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained >= 50% of tumor cells [TC >= 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering >= 10% of the tumor area [IC >= 10%] ), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.	2
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.	1
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.	1
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ.	2
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Atezolizumab
Sensitivity (+)	PD-L1 >= 50%	Non-Small Cell Lung Cancer	Atezolizumab
Sensitivity (+)	PD-L1 >= 10% TIIC	Non-Small Cell Lung Cancer	Atezolizumab
Sensitivity (+)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Atezolizumab, Bevacizumab, Carboplatin, Paclitaxel
Sensitivity (+)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Atezolizumab, Carboplatin, Paclitaxel
Sensitivity (+)	EGFR somatic variants	Non-Small Cell Lung Cancer	Atezolizumab
Sensitivity (+)	v::ALK	Non-Small Cell Lung Cancer	Atezolizumab
Sensitivity (+)	BRAF p.V600E	Melanoma	Atezolizumab, Cobimetinib, Vemurafenib
Sensitivity (+)	BRAF p.V600K	Melanoma	Atezolizumab, Cobimetinib, Vemurafenib