Amivantamab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2021
- First approval year
- 2021
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Amivantamab
- rybrevant
- Rybrevant
- amivantamab
- Amivantamab
- Amivantamab (to be determined)
- amivantamab [INN]
- AMIVANTAMAB [JAN]
- Amivantamab [MI]
- Amivantamab [WHO-DD]
- Amivantamab 1050mg
- Amivantamab 1400mg
- amivantamab inn
- Amivantamab Intravenous
- Amivantamab IV
- amivantamab jan
- amivantamab lpuj
- amivantamab lpuj component of rybrevant faspro
- amivantamab mi
- amivantamab vmjw
- Amivantamab vmjw
- Amivantamab vmjw [WHO-DD]
- amivantamab vmjw who dd
- amivantamab who dd
- Amivantamab-LPUJ
- Amivantamab-LPUJ Component of RYBREVANT FASPRO
- Amivantamab-vmjw
- anti egfr c met bispecific antibody jnj 61186372
And 16 more, listed on the interactive page.
- ATC classification codes
- L01FX18
Sources for recorded values
- CAS registry numbers
- 2171511-58-1
- ChEMBL ID
- CHEMBL4297774
- FDA ingredient codes (UNII)
- 0JSR7Z0NB6
- 2549198
- 2549199
- Applicant
- JANSSEN BIOTECH
- Approval date
- 21 May 2021
- Application number
- BLA761210
- Status
- Authorised
- Status date
- 9 Dec 2021
- Authorisation date
- 9 Dec 2021
- Approved indications
- Rybrevant is indicated: in combination with lazertinib for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations. in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI). in combination with carboplatin and pemetrexed for the first line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations. as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum based therapy.
- Product number
- EMEA/H/C/005454
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Carcinoma, Non-Small-Cell Lung
European medicines record
- Patents
- 0
- Designations
- 5
- 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
- amivantamab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- epidermal growth factor receptor
- Gene symbol
- EGFR
- Protein identifier
- P00533
- Median affinity
- 8.85
- Affinity units
- pKd
- Primary target
- Yes
- Action
- Binding
- Action type
- Binding
- Target
- MET proto-oncogene, receptor tyrosine kinase
- Gene symbol
- MET
- Protein identifier
- P08581
- Median affinity
- 10.4
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Epidermal growth factor receptor erbB1 inhibitor
- Action type
- Inhibitor
- Target
- Epidermal growth factor receptor
- Protein identifier
- P00533
- Mechanism
- Hepatocyte growth factor receptor inhibitor
- Action type
- Inhibitor
- Target
- Hepatocyte growth factor receptor
- Protein identifier
- P08581
- Mechanism
- Epidermal growth factor receptor erbB1 inhibitor
- Action type
- Inhibitor
- Target
- Epidermal growth factor receptor
- Mechanism
- Hepatocyte growth factor receptor inhibitor
- Action type
- Inhibitor
- Target
- Hepatocyte growth factor receptor
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0001056
- Subject identifier
- D013274
- Condition
- Salivary Gland Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0004669
- Subject identifier
- D012468
- Condition
- Lung Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0008903
- Subject identifier
- D008175
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0003060
- Condition identifier
- EFO_1001927
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001056
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004669
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004971
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005233
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005575
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005627
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0007256
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0007576
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008903
- Condition identifier
- MONDO_0010150
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0018177
- Highest recorded phase
- 1
- Event
- blood pressure decreased
- Reports
- 7
- Reporting signal score
- 9.48255
- Event
- cytopenia
- Reports
- 5
- Reporting signal score
- 12.3631
- Event
- decreased appetite
- Reports
- 10
- Reporting signal score
- 7.727
- Event
- dermatitis acneiform
- Reports
- 6
- Reporting signal score
- 19.3998
- Event
- embolism venous
- Reports
- 3
- Reporting signal score
- 9.14359
- Event
- enterocolitis
- Reports
- 4
- Reporting signal score
- 11.1983
- Event
- erosive pustular dermatosis
- Reports
- 3
- Reporting signal score
- 26.463
- Event
- erythema
- Reports
- 9
- Reporting signal score
- 6.8507
- Event
- febrile neutropenia
- Reports
- 18
- Reporting signal score
- 34.6781
- Event
- folliculitis
- Reports
- 4
- Reporting signal score
- 11.0171
- Event
- hypoalbuminaemia
- Reports
- 4
- Reporting signal score
- 10.0003
- Event
- infusion related reaction
- Reports
- 72
- Reporting signal score
- 255.25
- Event
- meningitis noninfective
- Reports
- 2
- Reporting signal score
- 12.9354
- Event
- mucosal inflammation
- Reports
- 7
- Reporting signal score
- 12.3644
- Event
- myelosuppression
- Reports
- 16
- Reporting signal score
- 55.7662
- Event
- neutropenia
- Reports
- 14
- Reporting signal score
- 13.919
- Event
- neutrophil count decreased
- Reports
- 5
- Reporting signal score
- 5.94299
- Event
- oedema
- Reports
- 7
- Reporting signal score
- 9.34156
- Event
- oxygen saturation decreased
- Reports
- 16
- Reporting signal score
- 36.153
- Event
- palmar erythema
- Reports
- 2
- Reporting signal score
- 7.49784
- Event
- pancytopenia
- Reports
- 7
- Reporting signal score
- 8.42922
- Event
- paronychia
- Reports
- 10
- Reporting signal score
- 39.3219
- Event
- peripheral vein thrombosis
- Reports
- 2
- Reporting signal score
- 14.9939
- Event
- platelet count decreased
- Reports
- 10
- Reporting signal score
- 10.2772
- Event
- pulmonary toxicity
- Reports
- 3
- Reporting signal score
- 7.55277
And 6 more, listed on the interactive page.
- NCT03767075
- NCT04077463
- NCT04487080
- NCT04538664
- NCT04965090
- NCT04988295
- NCT05299125
- NCT05388669
- NCT05488314
- NCT05498428
- NCT05601973
- NCT05663866
- NCT05801029
- NCT05908734
- NCT06083857
- NCT06116682
- NCT06120140
- NCT05074940
- NCT05117931
- NCT05653427
- NCT05845671
- NCT06385080
- Dose
- 1050 mg or 1400 mg
- Route
- Intravenous
- How often
- Weekly for 5 doses, then every 2 weeks from Week 7 onwards
- Administer as an infusion after dilution
- Administer via a peripheral line for Weeks 1-2
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain: (anti-EGFR)
- Type
- Protein
- Sequence
- QVQLVESGGGVVQPGRSLRLSCAASGFTFSTYGMHWVRQAPGKGLEWVAVIWDDGSYKYYGDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDGITMVRGVMKDYFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFLLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Heavy chain: (anti-MET)
- Type
- Protein
- Sequence
- QVQLVQSGAEVKKPGASVKVSCETSGYTFTSYGISWVRQAPGHGLEWMGWISAYNGYTNYAQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDLRGTNYFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Glycosylation sites (N)
- Sequence
- 305 $ 299''''
- Component
- Glycosylation sites (N)
- Sequence
- 305 $ 299''
- Component
- Disulfide bridges
- Sequence
- 22-96 $ 22''-96'' $ 23'-88' $ 23'''-88''' $ 134'-194' $ 134'''-194''' $ 146''-202'' $ 152-208 $ 214'-228 $ 214'''-222'' $ 234-228'' $ 237-231'' $ 263''-323'' $ 269-329 $ 369''-427'' $ 375-433
- Component
- Light chain: (anti-MET)
- Type
- Protein
- Sequence
- DIQMTQSPSSVSASVGDRVTITCRASQGISNWLAWFQHKPGKAPKLLIYAASSLLSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQANSFPITFGQGTRLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Light chain: (anti-EGFR)
- Type
- Protein
- Sequence
- AIQLTQSPSSLSASVGDRVTITCRASQDISSALVWYQQKPGKAPKLLIYDASSLESGVPSRFSGSESGTDFTLTISSLQPEDFATYYCQQFNSYPLTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 57894-501
- 57894-510
- 57894-514
- 57894-515
- 57894-522
Related records
Trials (45)
- 5G-EMERALD: Amivantamab in Malignant Brain Tumours
- A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)
- A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
- A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer
- A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
- A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure
- A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)
- A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer
- A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer
- A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer
- A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
- A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
- A Study of Amivantamab in Participants With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer
- A Study of Amivantamab in People With Esophagogastric Cancer
- A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
- A Study of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma
- A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
- A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer
- A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer
Approved for (2)
- Neoplasm
- Non-small cell lung carcinoma
In development for (5)
- Gastric cancer Phase 2
- Head and neck squamous cell carcinoma Phase 1
- Hepatocellular carcinoma Phase 2
- Lung cancer Phase 1
- Salivary gland cancer Phase 2