Talquetamab
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
- Talquetamab
- talvey
- Talvey
- Immunoglobulin G4 [233-proline,239-alanine,240-alanine,410-leucine,414-lysine], anti-(human CD3 antigen) (human monoclonal JNJ-63483043 γ4-chain), disulfide with human monoclonal JNJ-63483043 λ-chain, (231→224′), (234→227′)-bis(disulfide) with immunoglobulin G4 [226-proline,232-alanine,233-alanine] anti-(human G protein-coupled receptor GPRC5D) (human monoclonal JNJ-64386972 γ4-chain) disulfide with human monoclonal JNJ-64386972 λ-chain
- immunoglobulin g4 233 proline 239 alanine 240 alanine 410 leucine 414 lysine anti human cd3 antigen human monoclonal jnj 63483043 γ4 chain disulfide with human monoclonal jnj 63483043 λ chain 231 224 234 227 bis disulfide with immunoglobulin g4 226 proline 232 alanine 233 alanine anti human g protein coupled receptor gprc5d human monoclonal jnj 64386972 γ4 chain disulfide with human monoclonal jnj 64386972 λ chain
- immunoglobulin g4 kappa g4 lambda anti homo sapiens gprc5d g protein coupled receptor class c group 5 member d and anti homo sapiens cd3e cd3 epsilon leu 4 humanized and chimeric monoclonal antibody bispecific
- immunoglobulin g4 kappa g4 lambda anti homo sapiens gprc5d g protein coupled receptor class c group 5 member d and anti homo sapiens cd3e cd3 epsilon leu 4 humanized and chimeric monoclonal antibody bispecific gamma4 heavy chain humanized anti gprc5d 1 445 vh homo sapiens ighv1 18 01 89 8 ighd ighj4 01 92 9 8 8 11 1 118 homo sapiens ighg4 01 ch1 119 216 hinge 1 12 s10 p 226 217 228 ch2 f1 3 a 232 l1 2 a 233 229 338 ch3 339 443 chs 444 445 119 445 132 214 disulfide with kappa light chain humanized antigprc5d 1 214 v kappa homo sapiens igkv1 17 02 85 3 igkj2 01 100 6 3 9 1 107 homo sapiens igkc 01 100 km3 a45 1 153 v101 191 108 214 gamma4 heavy chain chimeric anti cd3e 1 452 vh mus musculus ighv10 1 02 89 8 homo sapiens ighv3 72 01 88 0 ighd ighj6 01 90 9 8 10 16 1 125 homo sapiens ighg4 01 ch1 126 223 hinge 1 12 s10 p 233 224 235 ch2 f1 3 a 239 l1 2 a 240 236 345 ch3 f85 1 l 410 r88 k 414 346 450 chs 451 452 126 452 139 214 disulfide with lambda light chain humanized anti cd3e 1 215 v lambda homo sapiens iglv7 43 01 81 9 iglj3 02 100 9 3 9 1 109 homo sapiens iglc2 01 100 110 215 dimer 224 231 227 234 bisdisulfide produced in chinese hamster ovary cho k1 cell line glycoform alfa
- IMMUNOGLOBULIN G4-KAPPA/G4-LAMBDA, ANTI-(HOMO SAPIENS GPRC5D (G PROTEIN-COUPLED RECEPTOR CLASS C GROUP 5 MEMBER D)), AND ANTI-(HOMO SAPIENS CD3E (CD3 EPSILON, LEU-4)), HUMANIZED AND CHIMERIC MONOCLONAL ANTIBODY, BISPECIFIC
- Immunoglobulin G4-kappa/G4-lambda, anti-[Homo sapiens GPRC5D (G protein-coupled receptor class C group 5 member D)], and anti-[Homo sapiens CD3E (CD3 epsilon, Leu-4)], humanized and chimeric monoclonal antibody; bispecific gamma4 heavy chain humanized anti-GPRC5D (1-445) [VH (Homo sapiens IGHV1-18*01 (89.8%) -(IGHD) -IGHJ4*01 (92.9%)) [8.8.11] (1-118) -Homo sapiens IGHG4*01 (CH1 (119-216), hinge 1-12 S10>P (226) (217-228), CH2 F1.3>A (232), L1.2>A (233) (229-338), CH3 (339-443), CHS (444-445)) (119-445)], (132-214')-disulfide with kappa light chain humanized antiGPRC5D (1'-214') [V-KAPPA (Homo sapiens IGKV1-17*02 (85.3%) -IGKJ2*01 (100%)) [6.3.9] (1'-107') -Homo sapiens IGKC*01 (100%), Km3 A45.1 (153), V101 (191) (108'-214’)]; gamma4 heavy chain chimeric anti-CD3E (1-452) [VH (Mus musculus IGHV10-1*02 (89.8%)/Homo sapiens IGHV3-72*01 (88.0%) -(IGHD) -IGHJ6*01 (90.9%)) [8.10.16] (1-125) -Homo sapiens IGHG4*01 (CH1 (126-223), hinge 1-12 S10>P (233) (224-235), CH2 F1.3>A (239), L1.2>A (240) (236-345), CH3 F85.1>L (410), R88>K (414) (346-450), CHS (451-452)) (126-452)], (139-214')-disulfide with lambda light chain humanized anti-CD3E (1'-215') [V-LAMBDA (Homo sapiens IGLV7-43*01 (81.9%) -IGLJ3*02 (100%)) [9.3.9] (1'-109') -Homo sapiens IGLC2*01 (100%) (110'-215’)]; dimer (224-231'':227-234'')-bisdisulfide, produced in Chinese Hamster Ovary (CHO)-K1 cell line, glycoform alfa
- jnj 63483043
- jnj 64407564
- JNJ-63483043
- JNJ-64407564
- talquetamab
- Talquetamab
- talquetamab [INN]
- Talquetamab [MI]
- TALQUETAMAB [USAN]
- Talquetamab [WHO-DD]
- talquetamab inn
- talquetamab mi
- talquetamab tgvs
- Talquetamab tgvs [WHO-DD]
- talquetamab tgvs who dd
- talquetamab usan
- talquetamab who dd
- Talquetamab-tgvs
- ATC classification codes
- L01FX29
Sources for recorded values
- CAS registry numbers
- 2226212-40-2
- ChEMBL ID
- CHEMBL4594503
- FDA ingredient codes (UNII)
- 4W3KFI3TN3
- 2644447
- 2644448
- Applicant
- JANSSEN BIOTECH
- Approval date
- 9 Aug 2023
- Application number
- BLA761342
- Status
- Authorised
- Status date
- 21 Aug 2023
- Authorisation date
- 21 Aug 2023
- Approved indications
- Talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti CD38 antibody and have demonstrated disease progression on the last therapy.
- Product number
- EMEA/H/C/005864
- Priority medicines scheme
- Yes
- 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
- Multiple Myeloma
European medicines record
- Patents
- 0
- Designations
- 6
- Earliest recorded loss of exclusivity
- 22 Aug 2033
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- Yes
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- talquetamab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- G-protein coupled receptor family C group 5 member D binding agent
- Action type
- BINDING_AGENT
- Target
- G-protein coupled receptor family C group 5 member D
- Protein identifier
- Q9NZD1
- 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
- GPRC5D
- Gene symbol
- GPRC5D
- Protein identifier
- Q9NZD1
- Mechanism
- G-protein coupled receptor family C group 5 member D binding agent
- Action type
- BINDING AGENT
- Target
- G-protein coupled receptor family C group 5 member D
- Mechanism
- T cell surface glycoprotein CD3 binding agent
- Action type
- BINDING AGENT
- Target
- T cell surface glycoprotein CD3
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Multiple Myeloma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Hematologic Diseases
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005570
- Subject identifier
- D006402
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0001378
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0009688
- Condition identifier
- MONDO_0009693
- Highest recorded phase
- 4
Warnings
- Warning
- Black Box Warning
- Effect
- immune system toxicity
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- immune system toxicity
- Country
- United States
- Event
- cytokine release syndrome
- Reports
- 5
- Reporting signal score
- 24.5998
- Event
- dysgeusia
- Reports
- 7
- Reporting signal score
- 26.3667
- Event
- immune effector cell-associated neurotoxicity syndrome
- Reports
- 2
- Reporting signal score
- 11.6435
- Event
- mucosal inflammation
- Reports
- 3
- Reporting signal score
- 9.50547
- Event
- plasma cell myeloma
- Reports
- 4
- Reporting signal score
- 14.0384
- Event
- skin exfoliation
- Reports
- 4
- Reporting signal score
- 13.9298
- NCT03399799
- NCT04634552
- NCT03601078
- NCT04108195
- NCT04586426
- NCT04773522
- NCT05050097
- NCT05338775
- NCT05455320
- NCT05461209
- NCT05552222
- NCT05849610
- NCT06066346
- NCT06100237
- NCT06208150
- NCT06348108
- NCT06353022
- NCT06461988
- Dose
- Initial step-up doses 0.01 mg/kg, 0.06 mg/kg, and 0.4 mg/kg; first treatment dose 0.4 or 0.8 mg/kg; subsequent doses 0.4 mg/kg or 0.8 mg/kg
- Route
- Subcutaneous
- How often
- Weekly or biweekly (every 2 weeks)
- Administer pretreatment medications prior to each dose as recommended
- Hospitalize for 48 hours after all doses within the step-up dosing schedule
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Glycosylation sites (N)
- Sequence
- 295 $ 302''''
- Component
- Heavy chain X (Anti- Anti-GPRC5D)
- Type
- Protein
- Sequence
- QVQLVQSGAEVKKPGASVKVSCKASGYSFTGYTMNWVRQAPGQGLEWMGLINPYNSDTNYAQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARVALRVALDYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- Component
- Heavy chain: (CD3E)
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGFTFNTYAMNWVRQAPGKGLEWVARIRSKYNNYATYYAASVKGRFTISRDDSKNSLYLQMNSLKTEDTAVYYCARHGNFGNSYVSWFAYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFLLYSKLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- Component
- Light chain: X''' (Anti-CD3)
- Type
- Protein
- Sequence
- QTVVTQEPSLTVSPGGTVTLTCRSSTGAVTTSNYANWVQQKPGQAPRGLIGGTNKRAPGTPARFSGSLLGGKAALTLSGVQPEDEAEYYCALWYSNLWVFGGGTKLTVLGQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS
- Component
- Light chain: X' (Anti-GPRC5D)
- Type
- Protein
- Sequence
- DIQMTQSPSSLSASVGDRVTITCKASQNVATHVGWYQQKPGKAPKRLIYSASYRYSGVPSRFSGSGSGTEFTLTISNLQPEDFATYYCQQYNRYPYTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Glycosylation sites (N)
- Sequence
- 295 $ 302''
- Component
- Disulfide bridges
- Sequence
- 22-96 $ 22''-98' $ 23'-88' $ 22'''-90''' $ 132-214' $ 134'-194' $ 139''-214''' $ 145-201 $ 152''-208'' $ 224-231' $ 224-234'' $ 259-319 $ 266''-326'' $ 365-423
- 57894-469
- 57894-470
Related records
Trials (38)
- A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment
- A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide
- A Study Comparing Treatment With Teclistamab and Talquetamab Versus Daratumumab and Lenalidomide in Patients With Multiple Myeloma After Stem Cell Transplant Who Still Have Detectable Disease
- A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
- A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma
- A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma
- A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma
- A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma
- A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma
- A Study of Talquetamab for People With Multiple Myeloma Who Have Received BCMA CAR T-Cell Therapy
- A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
- A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
- A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
- A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
- A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events
- An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma
- Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients
- Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma
- Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
- Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Approved for (2)
- Neoplasm
- Plasma cell myeloma
In development for (1)
- Hematologic disorder Phase 2