Teclistamab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2022
- First approval year
- 2022
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Teclistamab
- tecvayli
- Tecvayli
- bcmaxcd3
- BCMAxCD3
- Immunoglobulin G4 [233-proline, 239-alanine, 240-alanine, 410-leucine], anti- (human CD3 antigen) (human monoclonal JNJ-63483043 γ4-chain), disulfide with human monoclonal JNJ-63483043 λ-chain,(231→227'),(234→230')- bis(disulfide) with immunoglobulin G4 [229-proline, 235-alanine, 236-alanine, 410-arginine] anti-(human tumor necrosis factor receptor superfamily protein TNFRSF17) (human monoclonalJNJ-63705473 γ4-chain) disulfide with human monoclonal JNJ-63705473 λ-chain
- immunoglobulin g4 233 proline 239 alanine 240 alanine 410 leucine anti human cd3 antigen human monoclonal jnj 63483043 γ4 chain disulfide with human monoclonal jnj 63483043 λ chain 231 227 234 230 bis disulfide with immunoglobulin g4 229 proline 235 alanine 236 alanine 410 arginine anti human tumor necrosis factor receptor superfamily protein tnfrsf17 human monoclonaljnj 63705473 γ4 chain disulfide with human monoclonal jnj 63705473 λ chain
- immunoglobulin g4 lambda anti homo sapiens tnfrsf17 tnf receptor superfamily member 17 tumor necrosis factor receptor superfamily member 17 b cell maturation antigen bcma bcm tnfrsf13a cd269 and anti homo sapiens cd3 epsilon cd3e leu 4 monoclonal antibody bispecific gamma4 heavy chain anti tnfrsf17 1 448 vh homo sapiens ighv4 39 01 97 0 ighd ighj4 01 100 10 7 13 1 121 homo sapiens ighg4 01 ng4m a ch2 l92 g4v5 h p10 g4v4 ch2 a1 3 a1 2 ch1 122 219 hinge s10 p 229 220 231 ch2 l92 310 f1 3 a 235 l1 2 a 236 232 341 ch3 342 446 chs 447 448 122 448 135 213 disulfide with lambda light chain anti tnfrsf17 1 214 v lambda homo sapiens iglv3 21 02 96 9 iglj2 01 100 0 6 3 11 1 108 homo sapiens iglc2 01 99 1 a43 g 152 109 214
- immunoglobulin G4-lambda, anti-[Homo sapiens TNFRSF17 (TNF receptor superfamily member 17, tumor necrosis factor receptor superfamily, member 17, B cell maturation antigen, BCMA, BCM, TNFRSF13A, CD269)] and anti-[Homo sapiens CD3 epsilon (CD3E, Leu-4)], monoclonal antibody, bispecific; gamma4 heavy chain anti-TNFRSF17 (1-448) [VH (Homo sapiens IGHV4-39*01 (97.0%) -(IGHD) -IGHJ4*01 (100%)) [10.7.13] (1-121) -Homo sapiens IGHG4*01, nG4m(a) CH2 L92, G4v5 h P10, G4v4 CH2 A1.3, A1.2 (CH1 (122-219), hinge S10>P (229) (220-231), CH2 L92 (310), F1.3>A (235), L1.2>A (236) (232-341), CH3 (342-446), CHS (447-448)) (122-448)], (135-213')-disulfide with lambda light chain anti-TNFRSF17 (1'-214') [V-LAMBDA (Homo sapiens IGLV3-21*02 (96.9%) -IGLJ2*01 (100.0%)) [6.3.11] (1'-108') -Homo sapiens IGLC2*01 (99.1%) A43>G (152) (109'-214')]
- jnj 64007957
- Jnj 64007957
- JNJ-64007957
- teclistamab
- Teclistamab
- Teclistamab (Tec)
- teclistamab [INN]
- Teclistamab [MI]
- TECLISTAMAB [USAN]
- Teclistamab [WHO-DD]
- teclistamab cqyv
- Teclistamab cqyv
- Teclistamab cqyv [WHO-DD]
- teclistamab cqyv who dd
- teclistamab inn
- teclistamab mi
- teclistamab usan
- teclistamab who dd
- Teclistamab-cqyv
And 1 more, listed on the interactive page.
- CAS registry numbers
- 2119595-80-9
- ChEMBL ID
- CHEMBL4594505
- FDA ingredient codes (UNII)
- 54534MX6Z9
- L01F
- L01FX24
Sources for recorded values
- 2619425
- 2619426
- Applicant
- JANSSEN BIOTECH
- Approval date
- 25 Oct 2022
- Application number
- BLA761291
- Status
- Authorised
- Status date
- 23 Aug 2022
- Authorisation date
- 23 Aug 2022
- Approved indications
- Tecvayli is indicated in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three 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/005865
- Priority medicines scheme
- Yes
- 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
- Multiple Myeloma
European medicines record
- Patents
- 0
- Designations
- 6
- Earliest recorded loss of exclusivity
- 25 Oct 2029
- 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
- Boxed warning
- Yes
- Pharmacology name
- teclistamab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- 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
- Mechanism
- Tumor necrosis factor receptor superfamily member 17 binding agent
- Action type
- BINDING_AGENT
- Target
- Tumor necrosis factor receptor superfamily member 17
- Protein identifier
- Q02223
- Mechanism
- T cell surface glycoprotein CD3 binding agent
- Action type
- BINDING AGENT
- Target
- T cell surface glycoprotein CD3
- Mechanism
- Tumor necrosis factor receptor superfamily member 17 binding agent
- Action type
- BINDING AGENT
- Target
- Tumor necrosis factor receptor superfamily member 17
- 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
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0004992
- Subject identifier
- D009369
- Condition
- Hematologic Diseases
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0005570
- Subject identifier
- D006402
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0001378
- Condition identifier
- MONDO_0000430
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004992
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0009693
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0015667
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0017816
- Condition identifier
- MONDO_0018689
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018881
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0018908
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0019065
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0019438
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0044881
- Highest recorded phase
- 2
- Warning
- Black Box Warning
- Effect
- nephrotoxicity
- Warning
- Black Box Warning
- Effect
- neurotoxicity
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Warning
- Black Box Warning
- Effect
- nephrotoxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- neurotoxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Country
- United States
- Event
- cytokine release syndrome
- Reports
- 5
- Reporting signal score
- 22.8796
- Event
- iga nephropathy
- Reports
- 3
- Reporting signal score
- 16.6929
- Event
- ivth nerve paralysis
- Reports
- 2
- Reporting signal score
- 14.3402
- Event
- plasma cell myeloma refractory
- Reports
- 2
- Reporting signal score
- 16.103
- NCT03145181
- NCT04108195
- NCT04586426
- NCT04722146
- NCT05083169
- NCT05243797
- NCT05338775
- NCT05469893
- NCT05552222
- NCT05572229
- NCT05572515
- NCT05695508
- NCT05849610
- NCT05972135
- NCT06100237
- NCT06171685
- NCT06208150
- NCT06353022
- NCT06425991
- NCT06465316
- NCT04696809
- Dose
- 0.06 mg/kg, 0.3 mg/kg, 1.5 mg/kg
- Route
- Subcutaneous
- How often
- Once weekly, every 2 weeks, every 4 weeks, as needed
- Hospitalized for 48 hours after step-up doses 1 and 2
- Pre-treatment medications required prior to each dose
- Remain within proximity of healthcare facility for 48 hours after first treatment dose
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain: (BCMA)
- Type
- Protein
- Sequence
- QLQLQESGPGLVKPSETLSLTCTVSGGSISSGSYFWGWIRQPPGKGLEWIGSIYYSGITYYNPSLKSRVTISVDTSKNQFSLKLSSVTAADTAVYYCARHDGAVAGLFDYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- Component
- Glycosylation sites (N)
- Sequence
- Asn-298 $ Asn-302''''
- Component
- Heavy chain: (CD3E)
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGFTFNTYAMNWVRQAPGKGLEWVARIRSKYNNYATYYAASVKGRFTISRDDSKNSLYLQMNSLKTEDTAVYYCARHGNFGNSYVSWFAYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFLLYSKLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- Component
- Glycosylation sites (N)
- Sequence
- Asn-298 $ Asn-302''
- Component
- Disulfide bridges
- Sequence
- 22'-87' $ 22'''-90''' $ 22-97 $ 22''-98''' $ 135-213' $ 136'-195' $ 137'''-196''' $ 139''-214''' $ 148'-204 $ 152''-208'' $ 227-231'' $ 230-234'' $ 262-322 $ 266''-326'' $ 368-426 $ 372''-430''
- Component
- Light chain: (BCMA)
- Type
- Protein
- Sequence
- SYVLTQPPSVSVAPGQTARITCGGNNIGSKSVHWYQQPPGQAPVVVVYDDSDRPSGIPERFSGSNSGNTATLTISRVEAGDEAVYYCQVWDSSSDHVVFGGGTKLTVLGQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKGDSSPVKAGVETTTPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS
- Component
- Light chain: X''' (Anti-CD3)
- Type
- Protein
- Sequence
- QTVVTQEPSLTVSPGGTVTLTCRSSTGAVTTSNYANWVQQKPGQAPRGLIGGTNKRAPGTPARFSGSLLGGKAALTLSGVQPEDEAEYYCALWYSNLWVFGGGTKLTVLGQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS
- 57894-449
- 57894-450
Related records
Trials (88)
- A Phase II Randomized Therapeutic Optimization Trial for Subjects With Refractory Metastatic Colorectal Cancer Using ctDNA: Rapid 1 Trial
- A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL).
- A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis
- A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma
- A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
- A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
- 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 Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
- 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 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 IBRF Disorders of Consciousness Advanced Care/MultiModal Care Protocol in Severe Disorders of Consciousness
- 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 Teclistamab and Mezigdomide in People 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 Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma
- A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma
- A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
- A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
- A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
Approved for (3)
- Cancer
- Neoplasm
- Plasma cell myeloma
In development for (3)
- AL amyloidosis Phase 2
- Hematologic disorder Phase 1
- Hematopoietic and lymphoid cell neoplasm Phase 2