Epcoritamab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2023
- First approval year
- 2023
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Epcoritamab
- epkinly
- Epkinly
- tepkinly
- Tepkinly
- epcoritamab
- Epcoritamab
- Epcoritamab (maintenance)
- Epcoritamab (monotherapy)
- epcoritamab [INN]
- Epcoritamab [MI]
- EPCORITAMAB [USAN]
- Epcoritamab [WHO-DD]
- epcoritamab bysp
- Epcoritamab bysp [WHO-DD]
- epcoritamab bysp who dd
- epcoritamab inn
- epcoritamab mi
- epcoritamab usan
- epcoritamab who dd
- Epcoritamab-bysp
- epkinly
- Epkinly
- gen 3013
- GEN-3013
- gen3013
- GEN3013
- Immunoglobulin G1 [234-phenylalanine, 235-glutamic acid, 265-alanine, 405-leucine], anti-(human CD3 antigen) (human-Mus musculus monoclonal IgG1-huCACAO-FEAL γ1-chain), disulfide with human-Mus musculus monoclonal IgG1-huCACAO-FEAL λ-chain, (234→231'),(237→234')-bis(disulfide) with immunoglobulin G1 [234-phenylalanine, 235-glutamic acid, 265-alanine, 409-arginine] anti-(human CD20 antigen) (human monoclonal IgG1-7D8-FEAR γ1-chain) disulfide with human monoclonal IgG1-7D8-FEAR κ-chain
- immunoglobulin g1 234 phenylalanine 235 glutamic acid 265 alanine 405 leucine anti human cd3 antigen human mus musculus monoclonal igg1 hucacao feal γ1 chain disulfide with human mus musculus monoclonal igg1 hucacao feal λ chain 234 231 237 234 bis disulfide with immunoglobulin g1 234 phenylalanine 235 glutamic acid 265 alanine 409 arginine anti human cd20 antigen human monoclonal igg1 7d8 fear γ1 chain disulfide with human monoclonal igg1 7d8 fear κ chain
- immunoglobulin g1 lambda kappa anti homo sapiens cd3e cd3 epsilon and anti homo sapiens ms4a1 membrane spanning 4 domains subfamily a member 1 cd20 monoclonal bispecific antibody gamma1 heavy chain chimeric anti cd3e 1 454 vh mus musculus ighv10 1 02 93 9 ighd ighj3 01 93 3 homo sapiens ighv3 72 01 81 0 ighd ighj6 01 67 0 8 10 16 1 125 homo sapiens ighg1 03 g1m3 ng1m1 ch1 r120 222 126 223 hinge 1 15 224 238 ch2 l1 3 f 242 l1 2 e 243 d27 a 273 239 348 ch3 e12 364 m14 366 f85 1 l 413 349 453 chs k2 del 454 126 454 228 214 disulfide with lambda light chain chimeric 1 215 v lambda mus musculus iglv1 01 83 3 iglj1 01 100 homo sapiens iglv8 61 01 70 8 iglj3 02 100 9 3 9 1 109 homo sapiens iglc2 01 100 110 215 gamma1 heavy chain homo sapiens anti ms4a1 1 451 vh homo sapiens ighv3 9 01 96 0 ighd ighj6 01 100 8 8 15 1 122 homo sapiens ighg1 03 g1m3 g1m1 ch1 r120 219 123 220 hinge 1 15 221 235 ch2 l1 3 f 239 l1 2 e 240 d27 a 270 236 345 ch3 e12 361 m14 363 k88 r 414 346 450 chs k2 del 451 123 451 225 214 disulfide with kappa light chain homo sapiens 1 214 v kappa homo sapiens igkv3 11 01 100 igkj5 01 100 6 3 9 1 107 homo sapiens igkc 01 100 km3 a45 1 153 v101 191 108 214 dimer 234 231 237 234 bisdisulfide produced in chinese hamster ovary cho s cell line glycoform alfa
And 1 more, listed on the interactive page.
- ATC classification codes
- L01FX27
Sources for recorded values
- CAS registry numbers
- 2134641-34-0
- ChEMBL ID
- CHEMBL4650393
- FDA ingredient codes (UNII)
- D6OMY2L0WA
- 2637392
- 2637395
- Applicant
- GENMAB US, INC.
- Approval date
- 19 May 2023
- Application number
- BLA761324
- Status
- Authorised
- Status date
- 22 Sept 2023
- Authorisation date
- 22 Sept 2023
- Approved indications
- Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
- Product number
- EMEA/H/C/005985
- Authorisation holder
- AbbVie Deutschland GmbH & Co. KG
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- Yes
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Lymphoma, Large B-Cell, Diffuse
European medicines record
- Patents
- 0
- Designations
- 7
- Earliest recorded loss of exclusivity
- 26 Jun 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
- Boxed warning
- Yes
- Pharmacology name
- epcoritamab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Action type
- BINDING_AGENT
- Target
- B-lymphocyte antigen CD20
- Protein identifier
- P11836
- Mechanism
- T cell surface glycoprotein CD3 binding agent
- Action type
- BINDING_AGENT
- Target
- T cell surface glycoprotein CD3
- Protein identifier
- P04234
- Mechanism
- T cell surface glycoprotein CD3 binding agent
- Action type
- BINDING_AGENT
- Target
- T cell surface glycoprotein CD3
- Protein identifier
- P07766
- Mechanism
- T cell surface glycoprotein CD3 binding agent
- Action type
- BINDING_AGENT
- Target
- T cell surface glycoprotein CD3
- Protein identifier
- P09693
- Action
- Binding
- Action type
- Binding
- Target
- CD3e
- Gene symbol
- CD3E
- Protein identifier
- P07766
- Action
- Binding
- Action type
- Binding
- Target
- CD20 (membrane-spanning 4-domains, subfamily A, member 1)
- Gene symbol
- MS4A1
- Protein identifier
- P11836
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Action type
- BINDING AGENT
- Target
- B-lymphocyte antigen CD20
- Mechanism
- T cell surface glycoprotein CD3 binding agent
- Action type
- BINDING AGENT
- Target
- T cell surface glycoprotein CD3
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Lymphoma, Non-Hodgkin
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005952
- Subject identifier
- D008228
- Condition
- Lymphoma, Mantle-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001469
- Subject identifier
- D020522
- Condition
- Lymphoma, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001938
- Subject identifier
- D016393
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0018906
- Subject identifier
- D008224
- Condition identifier
- EFO_0000095
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000096
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000403
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0005952
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001469
- Condition identifier
- EFO_1001938
- Condition identifier
- MONDO_0002083
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0002571
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004948
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004949
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0007243
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0015759
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0017596
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0017604
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018876
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018905
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0018906
- Condition identifier
- MONDO_0018906
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0018908
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0019088
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0044889
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0100280
- Highest recorded phase
- 2
Warnings
- Warning
- Black Box Warning
- Effect
- immune system toxicity
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- immune system toxicity
- Country
- United States
- Event
- c-reactive protein increased
- Reports
- 10
- Reporting signal score
- 24.0307
- Event
- cholecystitis infective
- Reports
- 3
- Reporting signal score
- 12.6348
- Event
- covid-19
- Reports
- 10
- Reporting signal score
- 22.4988
- Event
- cytokine release syndrome
- Reports
- 50
- Reporting signal score
- 277.231
- Event
- dehydration
- Reports
- 8
- Reporting signal score
- 9.19018
- Event
- diffuse large b-cell lymphoma recurrent
- Reports
- 2
- Reporting signal score
- 7.48191
- Event
- escherichia sepsis
- Reports
- 2
- Reporting signal score
- 6.71971
- Event
- febrile neutropenia
- Reports
- 15
- Reporting signal score
- 33.2234
- Event
- hydronephrosis
- Reports
- 3
- Reporting signal score
- 8.10483
- Event
- immune effector cell-associated neurotoxicity syndrome
- Reports
- 4
- Reporting signal score
- 18.8372
- Event
- lymph node haemorrhage
- Reports
- 1
- Reporting signal score
- 7.38635
- Event
- neutropenic infection
- Reports
- 3
- Reporting signal score
- 14.088
- Event
- pneumocystis jirovecii infection
- Reports
- 5
- Reporting signal score
- 26.6779
- Event
- pyrexia
- Reports
- 21
- Reporting signal score
- 24.7032
- Event
- tumour lysis syndrome
- Reports
- 3
- Reporting signal score
- 8.15109
- NCT04358458
- NCT04623541
- NCT05791409
- NCT05409066
- NCT05783609
- NCT05848765
- NCT06112847
- NCT06191744
- NCT04628494
- NCT05578976
- NCT05660967
- NCT06045247
- NCT05201248
- NCT05206357
- NCT05283720
- NCT06414148
- Dose
- 0.16 mg, 0.8 mg, 3 mg, 48 mg
- Route
- Subcutaneous
- How often
- Every 28 days
- Administer by qualified healthcare professional
- Dilution required for 0.16 mg and 0.8 mg doses
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Glycosylation sites (N)
- Sequence
- 305 $ 302''''
- Component
- Heavy chain X (anti-CD3)
- Type
- Protein
- Sequence
- EVKLVESGGGLVQPGGSLRLSCAASGFTFNTYAMNWVRQAPGKGLEWVARIRSKYNNYATYYADSVKDRFTISRDDSKSSLYLQMNNLKTEDTAMYYCVRHGNFGNSYVSWFAYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPEFEGGPSVFLFPPKPKDTLMISRTPEVTCVVVAVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFLLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
- Component
- Heavy chain X'' (anti-CD20)
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPDRSLRLSCAASGFTFHDYAMHWVRQAPGKGLEWVSTISWNSGTIGYADSVKGRFTISRDNAKNSLYLQMNSLRAEDTALYYCAKDIQYGNYYYGMDVWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPEFEGGPSVFLFPPKPKDTLMISRTPEVTCVVVAVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
- Component
- Glycosylation sites (N)
- Sequence
- 305 $ 302''
- Component
- Disulfide bridges
- Sequence
- 22-98 $ 22'-90' $ 22''-96'' $ 23'''-88''' $ 134'''-194''' $ 137'-197' $ 149''-205'' $ 152-208 $ 228-214' $ 225''-214'' $ 234-231'' $ 237-234'' $ 266''-326'' $ 269-329 $ 372''-430'' $ 375-433
- Component
- Light chain: X''' (anti-CD20)
- Type
- Protein
- Sequence
- EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPARFSGSGSGTDFTLTISSLEPEDFAVYYCQQRSNWPITFGQGTRLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Light chain: L-lambda2 (L''') anti-CD3E
- Type
- Protein
- Sequence
- QAVVTQEPSFSVSPGGTVTLTCRSSTGAVTTSNYANWVQQTPGQAFRGLIGGTNKRAPGVPARFSGSLIGDKAALTITGAQADDESIYFCALWYSNLWVFGGGTKLTVLGQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS
- 82705-002
- 82705-010
Related records
Trials (58)
- A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
- A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)
- A Study of Epcoritamab With Lenalidomide and Tafasitamab in People With Diffuse Large B Cell Lymphoma
- A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
- A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma
- A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
- A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma
- A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
- A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China
- Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
- Epco, Zanu, Ritux for R/R FL or MZL
- Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL
- Epcoritamab and Lenalidomide in Treating Patients With Refractory or Relapsed Immunodeficiency-Related Large B-Cell Lymphoma
- Epcoritamab and Pola-R-mini-CHP for the Treatment of Diffuse Large B Cell Lymphoma in Elderly or Unfit Patients
- Epcoritamab and Rituximab for First-line Follicular Lymphoma
- Epcoritamab and Tazemetostat for the Treatment of Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
- Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy
- Epcoritamab for the Treatment of Relapsed or Refractory Post Transplant Lymphoproliferative Disorders
- Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome
Approved for (4)
- Diffuse large B-cell lymphoma
- Follicular lymphoma
- Neoplasm
- Neoplasm of mature B-cells
In development for (5)
- B-cell chronic lymphocytic leukemia Phase 1
- B-cell non-Hodgkin lymphoma Phase 1
- Lymphoma Phase 2
- Mantle cell lymphoma Phase 1
- Non-Hodgkin lymphoma Phase 2