Durvalumab
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
- Durvalumab
- imfinzi
- Imfinzi
- azd5363 olaparib durvalumab
- durvalumab
- Durvalumab
- DURVALUMAB
- Durvalumab - 1500 mg
- Durvalumab (Cohort 1-3)
- Durvalumab (Imfinzi)
- Durvalumab (Imfinzi) immunotherapy
- Durvalumab (MEDI 4736)
- Durvalumab (starting from cycle 9)
- durvalumab [INN]
- DURVALUMAB [JAN]
- DURVALUMAB [MI]
- DURVALUMAB [PURPLE BOOK CDER]
- DURVALUMAB [USAN]
- Durvalumab [WHO-DD]
- Durvalumab 1120 mg
- Durvalumab 1500 mg
- Durvalumab 1500 mg IV
- Durvalumab injection
- Durvalumab Injection
- durvalumab inn
- durvalumab jan
- durvalumab mi
- durvalumab purple book cder
And 15 more, listed on the interactive page.
- CAS registry numbers
- 1428935-60-7
- ChEMBL ID
- CHEMBL3301587
- RxNorm IDs (RxCUI)
- 1919503
- FDA ingredient codes (UNII)
- 28X28X9OKV
- L01FF03
- L01XC28
Sources for recorded values
- Applicant
- ASTRAZENECA UK LTD
- Approval date
- 1 May 2017
- Application number
- BLA761069
- Status
- Authorised
- Status date
- 21 Sept 2018
- Authorisation date
- 21 Sept 2018
- Approved indications
- Non-Small Cell Lung Cancer (NSCLC)Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Imfinzi as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1). Imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5.1).Imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations. Small Cell Lung Cancer (SCLC)Imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). Biliary Tract Cancer (BTC)Imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (BTC). Hepatocellular Carcinoma (HCC)Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Endometrial Cancer Imfinzi in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with: - Imfinzi as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR) - Imfinzi in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). Muscle Invasive Bladder Cancer (MIBC) Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC). Gastric or Gastro-oesophageal Junction Adenocarcinoma (GC/GEJC) Imfinzi in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant Imfinzi monotherapy, is indicated for the treatment of adults with resectable gastric or gastro‑oesophageal junction adenocarcinoma.
- Product number
- EMEA/H/C/004771
- Authorisation holder
- AstraZeneca AB
- 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
- Carcinoma, Non-Small-Cell Lung
European medicines record
- Patents
- 0
- Designations
- 9
- Earliest recorded loss of exclusivity
- 4 Dec 2031
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Pharmacology name
- durvalumab
- 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
- 8.7
- 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
- 1
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- 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
- Myelodysplastic Syndromes
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Squamous Cell Carcinoma of Head and Neck
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000199
- Subject identifier
- D000077195
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Adenocarcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000228
- Subject identifier
- D000230
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000294
- Subject identifier
- D001749
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Adenocarcinoma, Clear Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000348
- Subject identifier
- D018262
- 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
- 2
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Adenocarcinoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000501
- Subject identifier
- D018263
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Neoplasms, Germ Cell and Embryonal
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000514
- Subject identifier
- D009373
- Condition
- Glioblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Adenocarcinoma of Lung
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000571
- Subject identifier
- D000077192
- 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
- Carcinoma, Renal Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000640
- Subject identifier
- D002292
- Condition
- Thyroid Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000641
- Subject identifier
- D013964
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
And 72 more, listed on the interactive page.
- Condition identifier
- EFO_0000180
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000198
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000199
- Condition identifier
- EFO_0000222
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000305
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000348
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000349
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000403
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000503
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000514
- Highest recorded phase
- 2
- 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_0000673
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000681
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000691
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000702
- Condition identifier
- EFO_0000708
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000770
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001663
- Highest recorded phase
- 2
And 171 more, listed on the interactive page.
- Event
- adrenal insufficiency
- Reports
- 267
- Reporting signal score
- 524.94
- Event
- biliary tract infection
- Reports
- 32
- Reporting signal score
- 137.658
- Event
- colitis
- Reports
- 343
- Reporting signal score
- 415.011
- Event
- disease progression
- Reports
- 412
- Reporting signal score
- 237.291
- Event
- dizziness
- Reports
- 93
- Reporting signal score
- 215.36
- Event
- drug hypersensitivity
- Reports
- 11
- Reporting signal score
- 246.97
- Event
- encephalitis
- Reports
- 113
- Reporting signal score
- 191.566
- Event
- febrile neutropenia
- Reports
- 497
- Reporting signal score
- 449.847
- Event
- headache
- Reports
- 119
- Reporting signal score
- 243.979
- Event
- hepatic function abnormal
- Reports
- 341
- Reporting signal score
- 367.263
- Event
- hepatitis
- Reports
- 55
- Reporting signal score
- 56.7638
- Event
- hyperthyroidism
- Reports
- 187
- Reporting signal score
- 269.55
- Event
- hypophysitis
- Reports
- 20
- Reporting signal score
- 45.2261
- Event
- hypothyroidism
- Reports
- 405
- Reporting signal score
- 661.048
- Event
- immune-mediated hepatitis
- Reports
- 92
- Reporting signal score
- 289.576
- Event
- interstitial lung disease
- Reports
- 502
- Reporting signal score
- 602.793
- Event
- lung disorder
- Reports
- 67
- Reporting signal score
- 76.4103
- Event
- malignant neoplasm progression
- Reports
- 320
- Reporting signal score
- 214.626
- Event
- metastases to central nervous system
- Reports
- 175
- Reporting signal score
- 300.53
- Event
- myelosuppression
- Reports
- 180
- Reporting signal score
- 273.175
- Event
- myocarditis
- Reports
- 190
- Reporting signal score
- 333.16
- Event
- myositis
- Reports
- 141
- Reporting signal score
- 205.601
- Event
- nephritis
- Reports
- 27
- Reporting signal score
- 64.011
- Event
- neutrophil count decreased
- Reports
- 300
- Reporting signal score
- 270.139
- Event
- non-small cell lung cancer recurrent
- Reports
- 11
- Reporting signal score
- 51.8123
And 9 more, listed on the interactive page.
- NCT01042379
- NCT02299999
- NCT02628132
- NCT02649686
- NCT02685059
- NCT02802098
- NCT02826434
- NCT03167619
- NCT03616886
- NCT03820141
- NCT03872505
- NCT03874325
- NCT04053322
- NCT04176848
- NCT04538742
- NCT05215106
- NCT05582538
- NCT05629585
- NCT05795101
- NCT06103864
- NCT06112379
- NCT02489448
- NCT03594396
- NCT03740893
- NCT03742102
And 462 more, listed on the interactive page.
- Dose
- 1500 mg
- Route
- Intravenous
- How often
- Every 3 weeks
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGFTFSRYWMSWVRQAPGKGLEWVANIKQDGSEKYYVDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCAREGGWFGELAFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPEFEGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPASIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- EIVLTQSPGTLSLSPGERATLSCRASQRVSSSYLAWYQQKPGQAPRLLIYDASSRATGIPDRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYGSLPWTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 0310-4500
- 0310-4611
Related records
Trials (778)
- --SuPERIOR Trial--
- ......SMARTEST Trial......
- 1st Line Durvalumab in PS 2 NSCLC Patients
- A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)
- A Clinical Trial of Durvalumab (MEDI4736) as 1st Line Therapy in Advanced Non-small Cell Lung Cancer Patients
- A Clinical Trial of Durvalumab and Tremelimumab, Administered With Radiation Therapy or Ablation in Patients With Colorectal Cancer
- A Feasibility Study of Durvalumab +/- Oleclumab as Neoadjuvant Therapy for Muscle-invasive Bladder Cancer (BLASST-2)
- A French Real-life Study: EvaluatioN of durvALumab Utilization and Effectiveness for First Line Extensive Stage Small Cell Lung Cancer.
- A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC
- A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
- A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
- A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
- A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
- A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
- A Multi-Cancer, Multi-State, Platform Study of Durvalumab (MEDI4736) and Oleclumab (MEDI9447) in Pancreatic Adenocarcinoma, Non-Small Cell Lung Cancer and Squamous Cell Carcinoma of the Head and Neck to Correlate Clinical, Molecular and Immunologic Parameters With DNA Methylation
- A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas
- A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Solid Tumors
- A Multicentre Phase II Trial of Durvalumab Versus Physician's Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinomas
- A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies
- A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors
Approved for (4)
In development for (96)
- Acquired polycythemia vera Phase 1
- Acute myeloid leukemia Phase 2
- Adenocarcinoma Phase 2
- Anal carcinoma Phase 2
- Angiosarcoma Phase 2
- B-cell chronic lymphocytic leukemia Phase 1
- Bile duct cancer Phase 2
- Biliary tract cancer Phase 3
- Biliary tract neoplasm Phase 3
- Breast cancer Phase 3
- Breast carcinoma Phase 3
- Breast neoplasm Phase 3
- Cervical cancer Phase 3
- Cholangiocarcinoma Phase 2
- Chronic hepatitis B virus infection Phase 2
- Clear cell adenocarcinoma Phase 2
- Clear cell renal carcinoma Phase 3
- Colorectal adenocarcinoma Phase 2
- Colorectal cancer Phase 2
- Colorectal carcinoma Phase 2
Targets (1)
- CD274 Programmed cell death 1 ligand 1 inhibitor