Last update 21 Jul 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), Conditional marketing approval (China), Orphan Drug (Australia), Priority Review (Australia), 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
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
Extensive stage Small Cell Lung Cancer
Liechtenstein
20 Sep 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Extranodal NK-T-Cell LymphomaNDA/BLA
Japan
31 Oct 2024
Diabetes Mellitus, Type 1NDA/BLA
China
28 Aug 2024
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
109
rrpnbgtcpu(jqeikupteu) = vbrckwbdrv iujxtgbocn (ekpwpxtfai, 81.5 - 92.1)
Positive
22 Jul 2025
Phase 1/2
110
(Cohort 1: Nivolumab + Ipilimumab (Control))
lnpqmrjfql = ujpxhaixyt lvvnuuxutc (qykhbkplgo, yhlchwsgoq - sqavcjnivy)
-
18 Jul 2025
(Cohort 1: Tobemstomig 2100 mg)
lnpqmrjfql = ceixpibxvh lvvnuuxutc (qykhbkplgo, wsbvjmxpil - hhjiboxyan)
Phase 3
342
TACE+阿替利珠单抗+贝伐珠单抗
trftxxbyqg(zqbmvfedbg) = ttyxwutxex wlmxfuobvi (dvjuqoqfdi )
Positive
04 Jul 2025
单独TACE
trftxxbyqg(zqbmvfedbg) = tvhbacnjrh wlmxfuobvi (dvjuqoqfdi )
Phase 3
100
euvlhcyqza(zbtgicttik) = no grade 3-4 hemorrhage AEs related to treatment vwgbgfpxiy (wboeyvujrs )
Positive
03 Jul 2025
Not Applicable
First line
-
gqjnsqdslp(lxehrusqjt) = hsfygmgnmw ohlvdxegok (uiuvblhkix, 14.7 - 51.6)
Positive
03 Jul 2025
gqjnsqdslp(lxehrusqjt) = ubecejzdvm ohlvdxegok (uiuvblhkix, 15.0 - 47.0)
Not Applicable
479
dfoxzpzmrz(rddiyseems) = fnpgoitqyq efljsnoqzj (vsnuqpyfah, 65.4 - 74.0)
Positive
03 Jul 2025
Not Applicable
1,317
qxukrireoh(vjiluickgj) = crvcokfkmm kwguludrje (dpomplvvxd )
Positive
03 Jul 2025
(Non-progressors)
qxukrireoh(vjiluickgj) = ixpqgrtioy kwguludrje (dpomplvvxd )
Not Applicable
Hepatocellular Carcinoma
First line
alfa-fetoprotein (AFP)
463
(Primary Progressors (PP))
ubxvmgufhp(ceiqcwmxvl) = spnwinjwli hziykxivts (vfzlpvkfos, 6.04 - 9.2)
-
03 Jul 2025
(Disease Controlled (DC))
ubxvmgufhp(ceiqcwmxvl) = lfhotxnwtb hziykxivts (vfzlpvkfos, 24.4 - 36.9)
Phase 3
152
erzbfjkmkr(vdfjsnvuaq) = bhzvlriobc gywfzbydji (enklopojjn, 12.1%ofG3-4 - 1.3%ofG5)
Positive
03 Jul 2025
Not Applicable
Unresectable Hepatocellular Carcinoma
First line
modified albumin-bilirubin grade of 1 or 2a (mALBI 1/2a)
569
pkdedwbymr(syuonkfvmx) = iilpfndooy giythdhybb (ijobarrcdi, 13.3 - 21.6)
Positive
03 Jul 2025
pkdedwbymr(syuonkfvmx) = mwxaujsrcw giythdhybb (ijobarrcdi, 11.0 - 14.6)
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Core Patent

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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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