Drug · Monoclonal Antibody

Atezolizumab

CI-DRUG-00000084Explore in graph →NCIt C106250 CHEMBL3707227 CIViC Approved

Regulatory

Approvals (45)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Urothelial carcinoma Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (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 non small cell lung cancer (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 non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (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 carcinomaTecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy (see section 5.1). 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 target…

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	248	103	100	600	45	CA, EU, US	May 18, 2016	Oct 16, 2008
Malignant Lung Neoplasm	Approved	Phase 4	67	33	32	164	7	US	May 18, 2016	Aug 6, 2013
Malignant Liver Neoplasm	Approved	Phase 4	44	20	17	66	1	US	May 18, 2016	Sep 5, 2017
Malignant Bladder Neoplasm	Approved	Phase 3	12	2	3	25

Curated evidence

Clinical evidence (27)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–27 of 27 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
CD274 Expression5
Atezolizumab	Bladder Urothelial Carcinoma

Clinical trials

Trials with this intervention (618)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 251–300 of 618 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04294810	A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer(SKYSCRAPER-01)	completed	Phase 3	620	Hoffmann-La RocheINDUSTRY	23	Jan 30, 2026	clinicaltrials
NCT05542407	ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer

Molecule

Record

Kind: Monoclonal Antibody
Mechanism: Programmed cell death 1 ligand 1 inhibitor
Targets: 1 gene
UNII: 52CMI0WC3Y
Aliases: 0ine2sfd9e, Anti-PD-L1, Anti-PDL1, Atezolizumab, Atezolizumab component of tecentriq hybreza, Atezolizumab-tqjc, Immunoglobulin G1, Anti-(human CD Antigen Cd274) (Human Monoclonal MPDL3280A Heavy Chain), Disulfide With Human Monoclonal MPDL3280A Kappa-chain, Dimer, MPDL 3280A, MPDL-3280A, MPDL3280A, MPDL 328OA, MPDL328OA, RG 7446, RG-7446, RG7446, RO 5541267, RO5541267, Tecentriq, TECENTRIQ

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (9)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01FF05	ATEZOLIZUMAB
ATC (WHO)	L01XC32

HLA-DRA EXPRESSION1

Atezolizumab + Nivolumab + PembrolizumabSubstitutes

Cutaneous MelanomaALIAS

Predictive

Supports Sensitivity Response

accepted

EID985

Melanoma patients treated with Anti-PD1 or anti-PD-L1(nivolumab, pembrolizumab, MPDL3280A) therapy were analyzed for expression of HLA-DRA (the primary antigen-presenting molecule of the MHC-II pathwa… (full text at CIViC)

PMID 26822383 · Johnson et al., 2016 · Open in CIViC

BRAF V6004
Atezolizumab + Cobimetinib + VemurafenibCombination	Melanoma	Predictive	A	Supports Sensitivity Response	4	accepted	EID11238 In this phase 3, randomised, double-blind, placebo-controlled trial, 514 patients with unresectable stage IIIc–IV, BRAFV600 mutation-positive melanoma were randomly assigned to either 28-day cycles of… (full text at CIViC) PMID 32534646 · Gutzmer et al., 2020 · Open in CIViC	civic
〃	Melanoma	Predictive	A	Supports Sensitivity Response	4	submitted	EID13046 In the second interim analysis of the randomized phase III IMspire150 trial (NCT02908672), 514 patients with previously untreated unresectable stage IIIc or stage IV BRAF V600 mutation-positive melano… (full text at CIViC) PMID 36460017 · Ascierto et al., 2023 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID13043 In a multicenter, open-label phase Ib dose-escalation and cohort-expansion study (NCT01656642), 39 checkpoint inhibitor-naive patients with previously untreated, unresectable stage IIIC or metastatic … (full text at CIViC) PMID 31171876 · Sullivan et al., 2019 · Open in CIViC	civic
〃	Melanoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID13044 In the multicenter, open-label, single-arm phase II TRICOTEL study (NCT03625141), 65 patients with previously untreated BRAF V600 mutation-positive metastatic melanoma and CNS metastases received vemu… (full text at CIViC) PMID 37459873 · Dummer et al., 2023 · Open in CIViC	civic