Tebentafusp
Highest phase reached
Approved
Drug type
Protein
First approval year
2022
- First approval year
- 2022
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Tebentafusp
- kimmtrak
- Kimmtrak
- brenetafusp and tebentafusp
- imcgp 100
- IMCgp 100
- IMCGP-100
- imcgp100
- Imcgp100
- IMCgp100
- IMCGP100
- IMCgp100 injection
- immtac imcgp100
- IMMTAC IMCGP100
- immtac imcgpgp 100
- ImmTAC IMCgpgp 100
- kimmtrak
- Kimmtrak
- T CELL RECEPTOR .ALPHA. CHAIN (SYNTHETIC HUMAN) FUSION PROTEIN WITH T CELL RECEPTOR .BETA. CHAIN (SYNTHETIC HUMAN) FUSION PROTEIN WITH IMMUNOGLOBULIN, ANTI-(HUMAN CD3 ANTIGEN) (SYNTHETIC SCFV FRAGMENT)
- t cell receptor alpha chain synthetic human fusion protein with t cell receptor beta chain synthetic human fusion protein with immunoglobulin anti human cd3 antigen synthetic scfv fragment
- tebentafusp
- Tebentafusp
- Tebentafusp (IMCgp100)
- tebentafusp [INN]
- Tebentafusp [MI]
- TEBENTAFUSP [USAN]
- Tebentafusp [WHO-DD]
- tebentafusp inn
And 9 more, listed on the interactive page.
- ATC classification codes
- L01XX75
Sources for recorded values
- CAS registry numbers
- 1874157-95-5
- ChEMBL ID
- CHEMBL4297990
- FDA ingredient codes (UNII)
- N658GY6L3E
- 2590743
- 2590744
- Applicant
- IMMUNOCORE LTD
- Approval date
- 25 Jan 2022
- Application number
- BLA761228
- Status
- Authorised
- Status date
- 1 Apr 2022
- Authorisation date
- 1 Apr 2022
- Approved indications
- Kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
- Product number
- EMEA/H/C/004929
- Authorisation holder
- Immunocore Ireland Limited
- 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
- Uveal Neoplasms
European medicines record
- Patents
- 0
- Designations
- 5
- Earliest recorded loss of exclusivity
- 6 Apr 2032
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- Yes
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- tebentafusp
- Type
- Antibody
- Drug name stem
- -fusp
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
Mechanisms of action
- Mechanism
- Melanocyte protein PMEL binding agent
- Action type
- BINDING_AGENT
- Target
- Melanocyte protein PMEL
- Protein identifier
- P40967
Open Targets mechanisms
- Mechanism
- Melanocyte protein PMEL binding agent
- Action type
- BINDING AGENT
- Target
- Melanocyte protein PMEL
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Melanoma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- Uveal Melanoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:1000616
- Subject identifier
- D000098943
- Condition
- Uveal Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001230
- Subject identifier
- D014604
- Condition identifier
- EFO_0000389
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000756
- Condition identifier
- EFO_1000616
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001230
- Condition identifier
- MONDO_0001056
- Condition identifier
- MONDO_0001056
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0002659
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0002926
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005012
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005105
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0006486
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0021225
Warnings
- Warning
- Black Box Warning
Open Targets warnings
- Warning
- Black Box Warning
- Country
- United States
- Event
- cytokine release syndrome
- Reports
- 5
- Reporting signal score
- 31.0887
- Event
- hypotension
- Reports
- 4
- Reporting signal score
- 11.4031
- Event
- rash maculo-papular
- Reports
- 2
- Reporting signal score
- 7.81955
- NCT01209676
- NCT01211262
- NCT02535078
- NCT02889861
- NCT05315258
- NCT05549297
- NCT02570308
- NCT03070392
- NCT06070012
- NCT06246149
- NCT04262466
- Dose
- 20 mcg on Day 1, 30 mcg on Day 8, 68 mcg on Day 15, then 68 mcg once every week
- Route
- Intravenous
- How often
- Weekly after Day 15
Conditions of use
- Administer over 15-20 minutes
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Sequence A
- Type
- Protein
- Sequence
- AIQMTQSPSSLSASVGDRVTITCRASQDIRNYLNWYQQKPGKAPKLLIYYTSRLESGVPSRFSGSGSGTDYTLTISSLQPEDFATYYCQQGNTLPWTFGQGTKVEIKGGGGSGGGGSGGGGSGGGGSGGGSEVQLVESGGGLVQPGGSLRLSCAASGYSFTGYTMNWVRQAPGKGLEWVALINPYKGVSTYNQKFKDRFTISVDKSKNTAYLQMNSLRAEDTAVYYCARSGYYGDSDWYFDVWGQGTLVTVSSGGGGSDGGITQSPKYLFRKEGQNVTLSCEQNLNHDAMYWYRQDPGQGLRLIYYSWAQGDFQKGDIAEGYSVSREKKESFPLTVTSAQKNPTAFYLCASSWGAPYEQYFGPGTRLTVTEDLKNVFPPEVAVFEPSEAEISHTQKATLVCLATGFYPDHVELSWWVNGKEVHSGVCTDPQPLKEQPALNDSRYALSSRLRVSATFWQDPRNHFRCQVQFYGLSENDEWTQDRAKPVTQIVSAEAWGRAD
- Component
- Sequence B
- Type
- Protein
- Sequence
- AQQGEEDPQALSIQEGENATMNCSYKTSINNLQWYRQNSGRGLVHLILIRSNEREKHSGRLRVTLDTSKKSSSLLITASRAADTASYFCATDGSTPMQFGKGTRLSVIANIQKPDPAVYQLRDSKSSDKSVCLFTDFDSQTNVSQSKDSDVYITDKCVLDMRSMDFKSNSAVAWSNKSDFACANAFNNSIIPEDT
- 80446-401
Related records
Trials (19)
- A Cohort IND Expanded Access Program for Supporting Patient Access to Tebentafusp
- A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma
- A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma
- Adjuvant Tebentafusp in High Risk Ocular Melanoma
- DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors
- IMCgp100 in Advanced Unresectable Melanoma
- IMCgp100-401 Rollover Study
- Neoadjuvant Tebentafusp for Uveal Melanoma
- Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma
- Phase 1b/2 Study of the Combination of IMCgp100 With Durvalumab and/or Tremelimumab in Advanced Cutaneous Melanoma
- Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma
- Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
- Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
- Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
- Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma
- Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma
- Tebentafusp in Molecular Relapsed Disease (MRD) Melanoma
- Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
- Tebentafusp-tebn With LDT in Metastatic UM
Approved for (3)
- Melanoma
- Neoplasm
- Uveal cancer
In development for (2)
- Cutaneous melanoma Phase 2
- Uveal melanoma Phase 3
Other linked conditions (2)
- Gastric cancer
- Uvea neoplasm
Targets (1)
- PMEL Melanocyte protein PMEL binding agent