Panitumumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2006
- First approval year
- 2006
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Panitumumab
- vectibix
- Vectibix
- abenix
- Abenix
- abx egf
- ABX-EGF
- ABX-EGF (panitumumab)
- e7 6 3
- E7.6.3
- immunoglobulin anti human epidermal growth factor receptor human monoclonal abx egf heavy chain disulfide with human monoclonal abx egf light chain dimer
- immunoglobulin human anti human epidermal growth factor receptor monoclonal antibody abx egf
- IMMUNOGLOBULIN, ANTI-(HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR) (HUMAN MONOCLONAL ABX-EGF HEAVY CHAIN), DISULFIDE WITH HUMAN MONOCLONAL ABX-EGF LIGHT CHAIN, DIMER
- IMMUNOGLOBULIN, HUMAN (ANTI-HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR) MONOCLONAL ANTIBODY (ABX-EGF)
- l01xc08
- L01xc08
- panitumumab
- Panitumumab
- PANITUMUMAB
- panitumumab (ABX-EGF)
- Panitumumab (ABX-EGF)
- panitumumab (EGFR inhibitors)
- Panitumumab (Part 1a only)
- Panitumumab (Within maintenance phase)
- Panitumumab (Within re-induction phase)
- PANITUMUMAB [EMA EPAR]
- panitumumab [INN]
- PANITUMUMAB [JAN]
And 18 more, listed on the interactive page.
- CAS registry numbers
- 339177-26-3
- ChEMBL ID
- CHEMBL1201827
- RxNorm IDs (RxCUI)
- 263034
- FDA ingredient codes (UNII)
- 6A901E312A
- L01FE02
- L01XC08
Sources for recorded values
- Applicant
- AMGEN
- Approval date
- 27 Sept 2006
- Application number
- BLA125147
- Status
- Authorised
- Status date
- 3 Dec 2007
- Authorisation date
- 3 Dec 2007
- Approved indications
- Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): in first-line in combination with Folfox or Folfiri. in second-line in combination with Folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
- Product number
- EMEA/H/C/000741
- Authorisation holder
- Amgen 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
- Colorectal Neoplasms
European medicines record
- Patents
- 0
- Designations
- 3
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- panitumumab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Antagonist
- Action type
- Antagonist
- Target
- epidermal growth factor receptor
- Gene symbol
- EGFR
- Protein identifier
- P00533
- Median affinity
- 10.3
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Epidermal growth factor receptor erbB1 inhibitor
- Action type
- Inhibitor
- Target
- Epidermal growth factor receptor
- Protein identifier
- P00533
Open Targets mechanisms
- Mechanism
- Epidermal growth factor receptor erbB1 inhibitor
- Action type
- Inhibitor
- Target
- Epidermal growth factor receptor
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Breast Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000313
- Subject identifier
- D002277
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000365
- Subject identifier
- D015179
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000707
- Subject identifier
- D002294
- Condition
- Ovarian Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001075
- Subject identifier
- D010051
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Esophageal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002916
- Subject identifier
- D004938
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Brain Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003833
- Subject identifier
- D001932
- Condition
- Biliary Tract Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003891
- Subject identifier
- D001661
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004142
- Subject identifier
- D015179
- Condition
- Cholangiocarcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005221
- Subject identifier
- D018281
- Condition
- Triple Negative Breast Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005537
- Subject identifier
- D064726
- Condition
- Esophageal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005922
- Subject identifier
- D004938
- Condition
- Head and Neck Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0006859
- Subject identifier
- D006258
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000359
- Subject identifier
- D010190
- Condition
- Rectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000657
- Subject identifier
- D012004
- Condition
- Malignant Carcinoid Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000852
- Subject identifier
- D008303
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001951
- Subject identifier
- D015179
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0001187
- Subject identifier
- D001749
- Condition
- Brain Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0001657
- Subject identifier
- D001932
And 13 more, listed on the interactive page.
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000365
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000681
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000707
- Highest recorded phase
- 3
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004142
- Condition identifier
- EFO_0005922
- Highest recorded phase
- 2
- Condition identifier
- EFO_0006859
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000657
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000852
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001480
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001927
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001951
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0001056
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0001187
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002169
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002529
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0002670
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002974
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003060
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003198
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003219
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003220
- Highest recorded phase
- 2
And 48 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Effect
- dermatological toxicity
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- dermatological toxicity
- Country
- United States
- Event
- acne
- Reports
- 114
- Reporting signal score
- 166.508
- Event
- adenocarcinoma of colon
- Reports
- 36
- Reporting signal score
- 88.1845
- Event
- arthralgia
- Reports
- 22
- Reporting signal score
- 82.5674
- Event
- blood magnesium decreased
- Reports
- 74
- Reporting signal score
- 151.777
- Event
- carcinoembryonic antigen increased
- Reports
- 41
- Reporting signal score
- 116.709
- Event
- colon cancer
- Reports
- 80
- Reporting signal score
- 141.762
- Event
- colorectal cancer metastatic
- Reports
- 120
- Reporting signal score
- 510.665
- Event
- conjunctivitis
- Reports
- 94
- Reporting signal score
- 142.721
- Event
- decreased appetite
- Reports
- 291
- Reporting signal score
- 181.55
- Event
- dehydration
- Reports
- 190
- Reporting signal score
- 86.6896
- Event
- dermatitis acneiform
- Reports
- 532
- Reporting signal score
- 2,219.44
- Event
- diarrhoea
- Reports
- 747
- Reporting signal score
- 329.276
- Event
- disease progression
- Reports
- 295
- Reporting signal score
- 297.053
- Event
- dry skin
- Reports
- 241
- Reporting signal score
- 385.253
- Event
- febrile neutropenia
- Reports
- 195
- Reporting signal score
- 165.988
- Event
- folliculitis
- Reports
- 88
- Reporting signal score
- 202.061
- Event
- headache
- Reports
- 28
- Reporting signal score
- 141.332
- Event
- hypocalcaemia
- Reports
- 97
- Reporting signal score
- 113.324
- Event
- hypokalaemia
- Reports
- 130
- Reporting signal score
- 99.9763
- Event
- hypomagnesaemia
- Reports
- 419
- Reporting signal score
- 1,218.07
- Event
- injection site pain
- Reports
- 1
- Reporting signal score
- 91.3537
- Event
- interstitial lung disease
- Reports
- 121
- Reporting signal score
- 89.0743
- Event
- metastases to liver
- Reports
- 141
- Reporting signal score
- 298.847
- Event
- metastases to lung
- Reports
- 59
- Reporting signal score
- 98.8584
- Event
- mucosal inflammation
- Reports
- 199
- Reporting signal score
- 311.762
And 18 more, listed on the interactive page.
- NCT00004879
- NCT00039273
- NCT00089635
- NCT00111761
- NCT00111774
- NCT00113763
- NCT00113776
- NCT00115765
- NCT00389870
- NCT00647530
- NCT00655499
- NCT00814619
- NCT00842257
- NCT00867334
- NCT00885885
- NCT00940316
- NCT00967655
- NCT01110785
- NCT01126112
- NCT01215539
- NCT01226719
- NCT01504477
- NCT01776307
- NCT02008383
- NCT02394795
And 104 more, listed on the interactive page.
- Dose
- 6 mg/kg
- Route
- Intravenous
- How often
- Every 14 days
- Administer via infusion pump
- Dilute to 100 mL with saline
- Discard unused vial
- Do not freeze
- Infuse over 60 minutes (≤ 1000 mg) or 90 minutes (> 1000 mg)
- Use diluted solution within 6 hours at room temperature or 24 hours refrigerated
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 55513-954
- 55513-956
Related records
Trials (245)
- (89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma
- 5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet/Triplet Chemotherapy With Advanced Unresectab
- 5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab
- 89Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in HNSCC
- A Clinical Trial of Panitumumab in Combination With FOLFIRI Chemotherapy as Second Line Treatment in Subjects With Metastatic Colorectal Cancer Expressing Wild-type KRAS and Who Had Progressed ≥ 6 Months After the Last Dose of the First Line Chemotherapy
- A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With Metastatic Colorectal Cancer With Wild-type RAS as First-line Therapy in Combination With FOLFIRI
- A Phase 2 Basket Trial in Which Patients With Advanced Solid Tumors Carrying the KRAS G12C mUtation Receive Treatment With a Combination of Sotorasib and Panitumumab
- A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer
- A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer
- A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal Cancer
- A Randomized Phase 2 Pharmacokinetic Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck
- A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation
- A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors
- A Study of BBI608 in Adult Patients With Advanced Colorectal Cancer
- A Study of Perioperative Chemotherapy Plus Panitumumab in Patients With Colorectal Cancer Liver Metastases
- A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis
- A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer
- A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
- A Study to Investigate BGB-3245 (Brimarafenib) With Panitumumab in Participants With Advanced or Metastatic RAS Mutant Colorectal and Pancreatic Ductal Cancers
- A Trial of AMG 479, Everolimus (RAD001) and Panitumumab in Patients With Advanced Cancer - QUILT-3.007
Approved for (6)
In development for (32)
- Biliary tract neoplasm Phase 2
- Brain cancer Phase 1
- Brain neoplasm Phase 1
- Breast cancer Phase 2
- Breast carcinoma Phase 2
- Carcinoid syndrome Phase 2
- Carcinoma Phase 2
- Carcinoma of esophagus Phase 2
- Cervical cancer Phase 2
- Cholangiocarcinoma Phase 2
- Esophageal cancer Phase 2
- Esophageal squamous cell carcinoma Phase 2
- Exocrine pancreatic carcinoma Phase 2
- Fallopian tube cancer Phase 2
- Gallbladder cancer Phase 2
- Gastric adenocarcinoma Phase 2
- Head and neck cancer Phase 3
- Head and neck squamous cell carcinoma Phase 3
- Kidney cancer Phase 1
- Lung cancer Phase 2
Targets (1)
- EGFR Epidermal growth factor receptor erbB1 inhibitor