Atezolizumab
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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