Atezolizumab

Atezolizumab (Tecentriq, Roche Registration GmbH) has 13 EU-approved indications in 5 tumour types. 6 need a biomarker result: PD-L1 (4), ALK (1) and EGFR (1).
Approved indications of Atezolizumab
Biomarker requirementRegimenSettingConditions
Small cell lung cancer1
None
+ carboplatin and etoposide
1L
advanced
None
Non-small cell lung cancer8
PD-L1 expression on ≥ 50% TC, EGFR/ALK-negative
Monotherapy
Adj.
early
Following complete resection and platinum-based chemotherapy; High risk of recurrence
EGFR/ALK-negative
+ bevacizumab, paclitaxel and carboplatin
1L
metastatic
Non-squamous only
EGFR/ALK-negative
+ nab-paclitaxel and carboplatin
1L
metastatic
Non-squamous only
PD-L1 expression ≥ 50% TC or ≥ 10% IC, EGFR/ALK-negative
Monotherapy
1L
metastatic
None
None
Monotherapy
1L
advanced
Ineligible for platinum-based therapy
EGFR mutation
+ bevacizumab, paclitaxel and carboplatin
2L
metastatic
Non-squamous only; After failure of appropriate targeted therapies
ALK fusion
+ bevacizumab, paclitaxel and carboplatin
2L
metastatic
Non-squamous only; After failure of appropriate targeted therapies
None
Monotherapy
2L
advanced
After prior chemotherapy; patients with EGFR-mutant or ALK-positive NSCLC should also have received targeted therapies
Triple-negative breast cancer1
PD-L1 IC ≥ 1%
+ nab-paclitaxel
1L
advanced
No prior chemotherapy for metastatic disease
Hepatocellular carcinoma1
None
+ bevacizumab
1L
advanced
No prior systemic therapy
Urothelial carcinoma2
None
Monotherapy
2L
advanced
After prior platinum-containing chemotherapy
PD-L1 IC ≥ 5%
Monotherapy
Any line
advanced
Cisplatin-ineligible
Full text of section 4.1 (therapeutic indications)

Urothelial carcinoma (UC) Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic UC:  after prior platinum-containing chemotherapy, or  who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1). Early-stage non-small cell lung cancer (NSCLC) 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 (see section 5.1 for selection criteria). Advanced NSCLC 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 (see section 5.1). 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 (see section 5.1). 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 (see section 5.1). Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy (see section 5.1 for selection criteria). 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 (see section 5.1). Small cell lung cancer (SCLC) Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (see section 5.1). Triple-negative breast cancer (TNBC) 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. Hepatocellular carcinoma (HCC) Tecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable HCC who have not received prior systemic therapy (see section 5.1).

Label history

66 changes to the Tecentriq label since 2018, 8 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes