Atezolizumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2016
- First approval year
- 2016
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Atezolizumab
- atezolizumab component of tecentriq hybreza
- Atezolizumab component of tecentriq hybreza
- tecentriq
- Tecentriq
- 0ine2sfd9e
- an antibody to programmed death ligand 1 for cancer therapy
- AN ANTIBODY TO PROGRAMMED DEATH LIGAND 1 FOR CANCER THERAPY
- anti pd l1
- anti pdl1
- Anti-PD-L1
- Anti-PDL1
- atezolizumab
- Atezolizumab
- ATEZOLIZUMAB
- Atezolizumab (1200 mg every three weeks)
- Atezolizumab (1200mg via IV infusion)
- Atezolizumab (MPDL3280A)
- Atezolizumab (MPDL3280A) [TECENTRIQ]
- Atezolizumab (neoadjuvant)
- atezolizumab [INN]
- ATEZOLIZUMAB [JAN]
- ATEZOLIZUMAB [MI]
- ATEZOLIZUMAB [PURPLE BOOK CDER]
- Atezolizumab [TECENTRIQ]
- ATEZOLIZUMAB [USAN]
- Atezolizumab [WHO-DD]
- Atezolizumab 1200 mg
- Atezolizumab 1200 mg IV
- Atezolizumab 1680 MG
And 24 more, listed on the interactive page.
- CAS registry numbers
- 1380723-44-3
- ChEMBL ID
- CHEMBL3707227
- RxNorm IDs (RxCUI)
- 1792776
- FDA ingredient codes (UNII)
- 52CMI0WC3Y
- L01FF05
- L01XC32
Sources for recorded values
- Applicant
- GENENTECH INC
- Approval date
- 18 May 2016
- Application number
- BLA761034
- Status
- Authorised
- Status date
- 20 Sept 2017
- Authorisation date
- 20 Sept 2017
- Approved indications
- 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 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).
- Product number
- EMEA/H/C/004143
- Authorisation holder
- Roche Registration GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Breast Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Transitional Cell
- Small Cell Lung Carcinoma
- Urologic Neoplasms
European medicines record
- Patents
- 0
- Designations
- 9
- Earliest recorded loss of exclusivity
- 9 Dec 2029
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Pharmacology name
- atezolizumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- programmed cell death 1 ligand 1
- Gene symbol
- programmed cell death 1 ligand 1
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Programmed cell death 1 ligand 1 inhibitor
- Action type
- Inhibitor
- Target
- Programmed cell death 1 ligand 1
- Protein identifier
- Q9NZQ7
Open Targets mechanisms
- Mechanism
- Programmed cell death 1 ligand 1 inhibitor
- Action type
- Inhibitor
- Target
- Programmed cell death 1 ligand 1
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Hodgkin Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000196
- Subject identifier
- D011471
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Astrocytoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000272
- Subject identifier
- D001254
- Condition
- Breast Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000313
- Subject identifier
- D002277
- Condition
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000339
- Subject identifier
- D015464
- Condition
- Melanoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000389
- Subject identifier
- D008545
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Glioblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Mesothelioma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000588
- Subject identifier
- D008654
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Osteosarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000637
- Subject identifier
- D012516
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000640
- Subject identifier
- D002292
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
- Condition
- Sarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000691
- Subject identifier
- D012509
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
And 73 more, listed on the interactive page.
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000183
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000198
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000305
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000313
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000389
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000503
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000519
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000588
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000637
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000673
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000681
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000691
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000702
- Condition identifier
- EFO_0000707
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000768
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000770
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001061
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001075
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 1
- Condition identifier
- EFO_0002617
- Highest recorded phase
- 2
And 204 more, listed on the interactive page.
- Event
- adrenal insufficiency
- Reports
- 275
- Reporting signal score
- 524.851
- Event
- ascites
- Reports
- 190
- Reporting signal score
- 207.149
- Event
- colitis
- Reports
- 355
- Reporting signal score
- 412.141
- Event
- disease progression
- Reports
- 510
- Reporting signal score
- 341.211
- Event
- dizziness
- Reports
- 116
- Reporting signal score
- 213.803
- Event
- drug hypersensitivity
- Reports
- 11
- Reporting signal score
- 273.69
- Event
- encephalitis
- Reports
- 109
- Reporting signal score
- 204.727
- Event
- enterocolitis
- Reports
- 93
- Reporting signal score
- 165.753
- Event
- febrile neutropenia
- Reports
- 521
- Reporting signal score
- 453.042
- Event
- headache
- Reports
- 126
- Reporting signal score
- 273.472
- Event
- hepatic function abnormal
- Reports
- 357
- Reporting signal score
- 370.936
- Event
- hyperthyroidism
- Reports
- 202
- Reporting signal score
- 288.814
- Event
- hypothyroidism
- Reports
- 421
- Reporting signal score
- 667.076
- Event
- immune-mediated hepatitis
- Reports
- 93
- Reporting signal score
- 285.463
- Event
- interstitial lung disease
- Reports
- 521
- Reporting signal score
- 601.278
- Event
- liver disorder
- Reports
- 202
- Reporting signal score
- 175.522
- Event
- metastases to central nervous system
- Reports
- 183
- Reporting signal score
- 306.541
- Event
- myelosuppression
- Reports
- 182
- Reporting signal score
- 263.092
- Event
- myocarditis
- Reports
- 201
- Reporting signal score
- 346.105
- Event
- myositis
- Reports
- 155
- Reporting signal score
- 226.672
- Event
- nephritis
- Reports
- 76
- Reporting signal score
- 162.368
- Event
- neutrophil count decreased
- Reports
- 305
- Reporting signal score
- 256.236
- Event
- pneumonitis
- Reports
- 571
- Reporting signal score
- 1,046.23
- Event
- proteinuria
- Reports
- 257
- Reporting signal score
- 321.821
- Event
- pyrexia
- Reports
- 932
- Reporting signal score
- 226.623
And 3 more, listed on the interactive page.
- NCT00781612
- NCT01375842
- NCT01633970
- NCT02174172
- NCT02323191
- NCT02876510
- NCT02925234
- NCT03148418
- NCT03498521
- NCT03721679
- NCT03768063
- NCT04341181
- NCT04551521
- NCT04632992
- NCT04817956
- NCT04975958
- NCT05159245
- NCT05394337
- NCT05694013
- NCT05862285
- NCT06031441
- NCT01455103
- NCT01656642
- NCT02303951
- NCT02902029
And 469 more, listed on the interactive page.
- Dose
- 840 mg, 1200 mg, or 1680 mg
- Route
- Intravenous
- How often
- Every 2 weeks, every 3 weeks, or every 4 weeks
Conditions of use
- Administer over 60 minutes; if tolerated, subsequent infusions over 30 minutes
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Disulfide bridges location
- Sequence
- 22-96 | 22''-96'' | 23'-88' | 23'''-88''' | 134'-194' | 134'''-194''' | 145-201 | 145''-201'' | 214'-221 | 214'''-221'' | 227-227'' | 230-230'' | 262-322 | 262''-322'' | 368-426 | 368''-426''
- Component
- Heavy chain
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGFTFSDSWIHWVRQAPGKGLEWVAWISPYGGSTYYADSVKGRFTISADTSKNTAYLQMNSLRAEDTAVYYCARRHWPGGFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYASTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain
- Type
- Protein
- Sequence
- DIQMTQSPSSLSASVGDRVTITCRASQDVSTAVAWYQQKPGKAPKLLIYSASFLYSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQYLYHPATFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 50242-917
- 50242-918
- 50242-933
Related records
Trials (1,042)
- "neoBREASTIM": Atezolizumab Plus RP1 Oncolytic Immunotherapy in the NeoAdjuvant Setting of Triple-Negative Breast Cancer
- A Clinical Study Based on FAPI-PET/CT Technology to Predict Pathological Complete Response After Neoadjuvant Chemoradiotherapy for MSS Rectal Cancer
- A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer
- A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)
- A Clinical Study of QL1706 Combined With Chemotherapy as Neoadjuvant Therapy for High-Risk Locally Advanced Cervical Cancer
- A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma
- A Clinical Study of Tislelizumab Combined With TACE and Lenvatinib in the Neoadjuvant Treatment of Resectable HCC
- A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma
- A Combination Study of Rucaparib and Atezolizumab in Participants With Advanced Gynecologic Cancers and Triple-Negative Breast Cancer
- A Comparison of Laparoscopic With Open Distal Gastrectomy in Advanced Gastric Cancer After Neoadjuvant Chemotherapy
- A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors
- A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)
- A MolEcularly Guided Anti-Cancer Drug Off-Label Trial
- A MultIceNTER Phase I Peptide VaCcine Trial for the Treatment of H3-Mutated Gliomas
- A Multicenter Randomized Controlled Phase II Trial of Iparomlimab and Tuvonralimab (QL1706) Combined With SOX Chemotherapy Versus Chemotherapy Alone in the Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
- A Multicenter Trial to Identify Optimal Atezolizumab Biomarkers in the Setting of Recurrent Glioblastoma. The MOAB Trial
- A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients
- A Neoadjuvant Study of Abiraterone Acetate, Leuprolide Acetate, and Belzutifan in Men With Regional Prostate Cancer
- A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients
Approved for (12)
- Benign urinary system neoplasm
- Breast cancer
- Breast carcinoma
- Breast neoplasm
- Cancer
- Lung cancer
- Neoplasm
- Non-small cell lung carcinoma
- Small cell lung carcinoma
- Transitional cell carcinoma
- Triple-negative breast carcinoma
- Urothelial carcinoma
In development for (88)
- Acute myeloid leukemia Phase 1
- Acute myeloid leukemia by FAB classification Phase 1
- Adrenal cortex carcinoma Phase 2
- Alveolar soft part sarcoma Phase 2
- Anus cancer Phase 2
- Astrocytoma (excluding glioblastoma) Phase 2
- B-cell chronic lymphocytic leukemia Phase 2
- Biliary tract cancer Phase 2
- Carcinoma Phase 2
- Carcinoma of esophagus Phase 3
- Cervical cancer Phase 3
- Cervical carcinoma Phase 3
- Cholangiocarcinoma Phase 2
- Chronic myeloid leukemia Phase 1
- Colonic neoplasm Phase 2
- Colorectal cancer Phase 3
- Colorectal carcinoma Phase 3
- Colorectal neoplasm Phase 3
- Cutaneous melanoma Phase 3
- Diffuse large B-cell lymphoma Phase 2
Other linked conditions (2)
- Lung adenocarcinoma in situ
- Ulcer disease
Targets (1)
- CD274 Programmed cell death 1 ligand 1 inhibitor