Avelumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2017
- First approval year
- 2017
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Avelumab
- bavencio
- Bavencio
- avelumab
- Avelumab
- avelumab [INN]
- AVELUMAB [JAN]
- AVELUMAB [MI]
- AVELUMAB [PURPLE BOOK CDER]
- AVELUMAB [USAN]
- Avelumab [WHO-DD]
- avelumab inn
- avelumab jan
- avelumab mi
- avelumab purple book cder
- avelumab usan
- avelumab who dd
- bavencio
- Bavencio
- immunoglobulin g1 lambda1 anti homo sapiens cd274 programmed death ligand 1 pdl1 pd l1 b7 homolog 1 b7h1 homo sapiens monoclonal antibody
- IMMUNOGLOBULIN G1-LAMBDA1, ANTI-(HOMO SAPIENS CD274 (PROGRAMMED DEATH LIGAND 1, PDL1, PD-L1, B7 HOMOLOG 1, B7H1)), HOMO SAPIENS MONOCLONAL ANTIBODY
- msb 0010682
- msb 0010718c
- MSB-0010682
- Msb-0010718c
- msb0010682
- MSB0010682
- msb0010718c
And 1 more, listed on the interactive page.
- ATC classification codes
- L01FF04
Sources for recorded values
- CAS registry numbers
- 1537032-82-8
- ChEMBL ID
- CHEMBL3833373
- RxNorm IDs (RxCUI)
- 1875534
- FDA ingredient codes (UNII)
- KXG2PJ551I
- Applicant
- EMD SERONO INC
- Approval date
- 23 Mar 2017
- Application number
- BLA761049
- Status
- Authorised
- Status date
- 18 Sept 2017
- Authorisation date
- 18 Sept 2017
- Approved indications
- Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Bavencio is indicated as monotherapy for the first?line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum?based chemotherapy.
- Product number
- EMEA/H/C/004338
- Authorisation holder
- Merck Europe B.V.
- 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
- Neuroendocrine Tumors
European medicines record
- Patents
- 0
- Designations
- 8
- Earliest recorded loss of exclusivity
- 23 Mar 2024
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Pharmacology name
- avelumab
- Type
- Antibody
- Drug name stem
- -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
- Median affinity
- 10.15
- Affinity units
- pIC50
- Primary target
- Yes
- Mechanism
- Programmed cell death 1 ligand 1 other
- Action type
- OTHER
- Target
- Programmed cell death 1 ligand 1
- Protein identifier
- Q9NZQ7
Open Targets mechanisms
- Mechanism
- Programmed cell death 1 ligand 1 other
- Action type
- OTHER
- Target
- Programmed cell death 1 ligand 1
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 1
- 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
- 2
- 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
- 1
- Condition identifier
- EFO:0000196
- Subject identifier
- D011471
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Adenocarcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000228
- Subject identifier
- D000230
- Condition
- Carcinoma, Adenoid Cystic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000231
- Subject identifier
- D003528
- Condition
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000339
- Subject identifier
- D015464
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000349
- Subject identifier
- D002292
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000365
- Subject identifier
- D015179
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Glioblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Leiomyosarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000564
- Subject identifier
- D007890
- Condition
- Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Mesothelioma
- Highest recorded phase
- 1
- 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:0000681
- Subject identifier
- D002292
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000707
- Subject identifier
- D002294
- Condition
- Melanoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001663
- Subject identifier
- D011471
And 47 more, listed on the interactive page.
- Condition identifier
- EFO_0000096
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000183
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000222
- Condition identifier
- EFO_0000228
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000294
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000503
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000519
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000564
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000588
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000637
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000681
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000702
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000707
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003863
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003869
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004252
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004281
- Highest recorded phase
- 2
And 126 more, listed on the interactive page.
- Event
- adrenal insufficiency
- Reports
- 19
- Reporting signal score
- 32.5369
- Event
- autoimmune myocarditis
- Reports
- 5
- Reporting signal score
- 21.9894
- Event
- chills
- Reports
- 55
- Reporting signal score
- 45.8587
- Event
- colitis
- Reports
- 28
- Reporting signal score
- 30.6584
- Event
- disease progression
- Reports
- 82
- Reporting signal score
- 98.6816
- Event
- endocrine toxicity
- Reports
- 5
- Reporting signal score
- 29.4222
- Event
- general physical health deterioration
- Reports
- 37
- Reporting signal score
- 27.3291
- Event
- headache
- Reports
- 6
- Reporting signal score
- 31.8986
- Event
- hepatitis
- Reports
- 21
- Reporting signal score
- 19.8865
- Event
- hyperthyroidism
- Reports
- 16
- Reporting signal score
- 21.8416
- Event
- hypothyroidism
- Reports
- 22
- Reporting signal score
- 25.1846
- Event
- infusion related reaction
- Reports
- 67
- Reporting signal score
- 89.583
- Event
- interstitial lung disease
- Reports
- 37
- Reporting signal score
- 36.9147
- Event
- myasthenia gravis
- Reports
- 11
- Reporting signal score
- 22.9987
- Event
- myocarditis
- Reports
- 22
- Reporting signal score
- 43.1095
- Event
- myositis
- Reports
- 24
- Reporting signal score
- 48.5324
- Event
- pneumonitis
- Reports
- 27
- Reporting signal score
- 34.8027
- Event
- skin toxicity
- Reports
- 18
- Reporting signal score
- 39.5075
- Event
- tumour pseudoprogression
- Reports
- 6
- Reporting signal score
- 18.2541
- NCT01772004
- NCT01943461
- NCT02222922
- NCT02994953
- NCT03330405
- NCT03491345
- NCT03523390
- NCT03565991
- NCT03724890
- NCT03815643
- NCT03861403
- NCT04266912
- NCT04341181
- NCT04551885
- NCT05396833
- NCT06302426
- NCT02155647
- NCT03167164
- NCT03271372
- NCT03787602
- NCT03853317
- NCT04261855
- NCT04393753
- NCT04792073
- NCT04874831
And 150 more, listed on the interactive page.
- Dose
- 800 mg
- Route
- Intravenous
- How often
- Every 2 weeks
- Administer over 60 minutes
- Premedicate with antihistamine and acetaminophen for first 4 infusions
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Glycosylation sites (N)
- Sequence
- Asn-300$Asn-300''''
- Component
- Disulfide bridges location
- Sequence
- 22-96$22''-96''$22'-90'$22'''-90'''$138'-197'$138'''-197'''$147-203$147''-203''$215'-223$215'''-223''$229-229''$232-232''$264-324$264''-324''$370-428$370''-428''
- Component
- Heavy chain
- Type
- Protein
- Sequence
- EVQLLESGGGLVQPGGSLRLSCAASGFTFSSYIMMWVRQAPGKGLEWVSSIYPSGGITFYADTVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARIKLGTVTTVDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain
- Type
- Protein
- Sequence
- QSALTQPASVSGSPGQSITISCTGTSSDVGGYNYVSWYQQHPGKAPKLMIYDVSNRPSGVSNRFSGSKSGNTASLTISGLQAEDEADYYCSSYTSSSTRVFGTGTKVTVLGQPKANPTVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADGSPVKAGVETTKPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS
- Component
- Glycosylation sites (N)
- Sequence
- Asn-300$Asn-300''
- 44087-3535
Related records
Trials (261)
- A Combination of Avelumab and Taxane (AVETAX) for Urothelial Cancer
- A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
- A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors
- A Dose-Finding Study of the Second Mitochondrial Activator of Caspases (SMAC) Mimetic Debio 1143 When Given in Combination With Avelumab to Participants With Advanced Solid Malignancies and to Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Platinum-Based Therapy
- A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA
- A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)
- A Phase II Trial of Avelumab in Patients With Recurrent or Progressive Osteosarcoma
- A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
- A Proof of Concept Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer
- A Proof of Concept, Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer
- A Study Combining Eribulin Mesylate With Avelumab in Cisplatin Ineligible Metastatic Urothelial Cell Cancer Patients
- A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)
- A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100)
- A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)
- A Study of Avelumab in Combination With Axitinib In Non-Small Cell Lung Cancer (NSCLC) or Urothelial Cancer (Javelin Medley VEGF)
- A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)
- A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
- A Study of Avelumab in Penile Cancer Who Are Unfit for or Have Progressed After Platinum-Based Chemotherapy
- A Study of Avelumab in Real-World Treatment for Patients With Advanced or Metastatic Urothelial Cancer
- A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
Approved for (5)
In development for (70)
- Acute myeloid leukemia Phase 1
- Adenocarcinoma Phase 2
- Adenoid cystic carcinoma Phase 2
- Angiosarcoma Phase 2
- Breast cancer Phase 3
- Breast neoplasm Phase 3
- Central nervous system neoplasm Phase 1
- Chordoma Phase 1
- Chronic myeloid leukemia Phase 1
- Clear cell renal carcinoma Phase 3
- Colon carcinoma Phase 3
- Colorectal adenocarcinoma Phase 2
- Colorectal cancer Phase 2
- Colorectal carcinoma Phase 2
- Colorectal neoplasm Phase 2
- Diffuse large B-cell lymphoma Phase 3
- Endometrial cancer Phase 2
- Esophageal squamous cell carcinoma Phase 2
- Exocrine pancreatic carcinoma Phase 2
- Fallopian tube cancer Phase 1
Targets (1)
- CD274 Programmed cell death 1 ligand 1 other