Tecentriq (atezolizumab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Roche Registration GmbH. Tecentriq (atezolizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf. Revised March 2024. Accessed March 23, 2024.

Regulatory approvals

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

Indication	Statements
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic UC (i) after prior platinum-containing chemotherapy, or (ii) who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression >= 5%.	1
Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on >= 50% of tumour cells (TC) and who do not have EGFR mutant or ALK-positive NSCLC.	1
Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC. In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.	2
Tecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK-positive NSCLC.	3
Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumours have a PD-L1 expression >= 50% TC or >= 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC.	2
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK-positive NSCLC should also have received targeted therapies before receiving Tecentriq.	2
Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression >= 1% and who have not received prior chemotherapy for metastatic disease.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	EGFR somatic variants	Non-Small Cell Lung Cancer	Atezolizumab
EMA (1)	v::ALK	Non-Small Cell Lung Cancer	Atezolizumab
EMA (1)	PD-L1 >= 5%	Bladder Urothelial Carcinoma	Atezolizumab
EMA (2)	PD-L1 >= 50%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Atezolizumab
EMA (1)	EGFR somatic variants	Non-Small Cell Lung Cancer	Atezolizumab, Bevacizumab, Carboplatin, Paclitaxel
EMA (1)	v::ALK	Non-Small Cell Lung Cancer	Atezolizumab, Bevacizumab, Carboplatin, Paclitaxel
EMA (1)	Wild type EGFR	Non-Small Cell Lung Cancer	Atezolizumab, Carboplatin, Nab-paclitaxel
EMA (1)	Wild type ALK	Non-Small Cell Lung Cancer	Atezolizumab, Carboplatin, Nab-paclitaxel
EMA (1)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Atezolizumab, Carboplatin, Nab-paclitaxel
EMA (1)	PD-L1 >= 10% TIIC, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Atezolizumab
EMA (1)	ER negative, HER2-negative, PD-L1 >= 1%, PR negative	Invasive Breast Carcinoma	Atezolizumab, Nab-paclitaxel