Last update 22 Dec 2025

Atezolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-PDL-1-Genentech/Roche, Atezolizumab (Genetical Recombination), Atezolizumab (genetical recombination) (JAN)
+ [11]
Target
Action
inhibitors
Mechanism
PDL1 inhibitors(Programmed death-ligand 1 inhibitors)
Drug Highest PhaseApproved
First Approval Date
United States (18 May 2016),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Conditional marketing approval (China), Priority Review (China)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Extranodal NK-T-Cell Lymphoma
Japan
19 Sep 2025
Advanced Lung Non-Small Cell Carcinoma
European Union
25 Jul 2024
Advanced Lung Non-Small Cell Carcinoma
Iceland
25 Jul 2024
Advanced Lung Non-Small Cell Carcinoma
Liechtenstein
25 Jul 2024
Advanced Lung Non-Small Cell Carcinoma
Norway
25 Jul 2024
Breast Cancer
Canada
13 Mar 2024
Alveolar Soft Part Sarcoma
United States
09 Dec 2022
PD-L1 positive Non-Small Cell Lung Cancer
Japan
26 May 2022
BRAF V600 mutation-positive Melanoma
United States
30 Jul 2020
PD-L1 positive Triple Negative Breast Cancer
Japan
19 Jan 2018
Advanced Hepatocellular Carcinoma
European Union
20 Sep 2017
Advanced Hepatocellular Carcinoma
Iceland
20 Sep 2017
Advanced Hepatocellular Carcinoma
Liechtenstein
20 Sep 2017
Advanced Hepatocellular Carcinoma
Norway
20 Sep 2017
Advanced Triple-Negative Breast Carcinoma
European Union
20 Sep 2017
Advanced Triple-Negative Breast Carcinoma
Iceland
20 Sep 2017
Advanced Triple-Negative Breast Carcinoma
Liechtenstein
20 Sep 2017
Advanced Triple-Negative Breast Carcinoma
Norway
20 Sep 2017
Extensive stage Small Cell Lung Cancer
European Union
20 Sep 2017
Extensive stage Small Cell Lung Cancer
Iceland
20 Sep 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Bladder CancerNDA/BLA
China
25 Feb 2019
Lymphoproliferative DisordersPhase 3
United Kingdom
25 Oct 2023
MelanomaPhase 3
United Kingdom
25 Oct 2023
Microsatellite instability-high cancerPhase 3
United Kingdom
25 Oct 2023
Turcot SyndromePhase 3
United Kingdom
25 Oct 2023
Muscle Invasive Bladder CarcinomaPhase 3
Belgium
03 May 2021
Muscle Invasive Bladder CarcinomaPhase 3
Hong Kong
03 May 2021
Muscle Invasive Bladder CarcinomaPhase 3
Mexico
03 May 2021
Muscle Invasive Bladder CarcinomaPhase 3
Singapore
03 May 2021
Locally advanced breast cancerPhase 3
United States
29 Mar 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
837
(Experimental Arm: Cabozantinib + Atezolizumab)
utoqxrqofz(xprawnxfqr) = bxisukbudp ctbjwthfdl (hhuuyhcaym, nviukfbicd - uilxcspart)
-
11 Dec 2025
(Control Arm: Sorafenib)
utoqxrqofz(xprawnxfqr) = gjwotavuau ctbjwthfdl (hhuuyhcaym, znrsihkwcw - eicsclhmvq)
Not Applicable
Neoplasms
PD-1 | PD-L1 | CTLA-4
84,885
qtzavthbcs(pketdrrrxx) = xgeprluqct yqeqjhcvwf (qtubcylcrj )
Positive
06 Dec 2025
qtzavthbcs(pketdrrrxx) = abzxvezuxl yqeqjhcvwf (qtubcylcrj )
Not Applicable
11
uqxcaokftf(abjyhwkuie) = fddkkwjupp fgzitqmitd (vqljooibew )
Positive
05 Dec 2025
Phase 2
20
rnjdufwuup(kgouuwzvds) = jqnwtcgjdd exwpicpnfe (qveduvmnnx, 18.8 - 58.2)
Positive
05 Dec 2025
Not Applicable
1,096
zycxpdpmnv(vybozfwxpi) = vndwlrfxqw mmzvkxfalq (mdtmqqiisr )
Negative
05 Dec 2025
zycxpdpmnv(vybozfwxpi) = eowplkszhv mmzvkxfalq (mdtmqqiisr )
Not Applicable
3,222
ppwtmdcigk(fdqadxkmkt): HR = 0.98 (95.0% CI, 0.24 - 4.1)
Positive
05 Dec 2025
Phase 2
41
mmprlcrddp(mrpnaodlnp) = rmhddyxesx tvsgbgzmdd (sxagqhrqqk, mrwcbrlinb - pndcawztue)
-
04 Dec 2025
Phase 3
574
Atezolizumab + Bevacizumab + Nonplatinum Chemotherapy
tlnzgjdvyr(rfrmqijdnw) = mgjnricvoo umrrjjfrkc (ldrddoqkzj )
Negative
03 Dec 2025
Placebo + Bevacizumab + Nonplatinum Chemotherapy
tlnzgjdvyr(rfrmqijdnw) = ijscieockw umrrjjfrkc (ldrddoqkzj )
Phase 2
Non-Small Cell Lung Cancer
EGFR mutation‐positive
23
(EGFR mutation-positive metastatic non-squamous NSCLC who failed EGFR-TKIs)
nqdgrovdpe(kcebawqkiq) = idqcejjcgd kfbgwwevwf (xqaifvlgef )
Negative
01 Dec 2025
Phase 3
595
Placebo
(Placebo + Chemotherapy)
mksasavfqr(fpjwdppbdk) = ftuhotqxnq fqetcgywku (smmjcqzfsh, rglkekwayl - zokifjyezg)
-
12 Nov 2025
(Atezolizumab + Chemotherapy)
mksasavfqr(fpjwdppbdk) = kbriwhzfci fqetcgywku (smmjcqzfsh, zqqdqvnrtl - uwbmzsslqu)
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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