Tarlatamab
Highest phase reached
Approved
Drug type
Antibody
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Tarlatamab
- imdelltra
- Imdelltra
- amg 757
- AMG 757
- AMG-757
- amg757
- AMG757
- imdelltra
- Imdelltra
- immunoglobulin anti human notch ligand dll3 human monoclonal daeldhwzv 1 single chain variable fragment vh1 ggggs 3 vl1 fusion protein with peptide linker ggggs fusion protein with immunoglobulin anti human cd3 antigen ε chain human monoclonal daeld hwzv 1 single chain variable fragment vh2 ggggs 3 vl2 fusion protein with peptide linker gggg fusion protein with immunoglobulin g1 human γ1 chain c region c terminal fragment fusion protein with peptide linker ggggs 6 fusion protein with immunoglobulin g1 human γ1 chain c region c terminal fragment
- immunoglobulin scfv scfv scfc anti homo sapiens dll3 delta like ligand 3 and anti homo sapiens cd3e cd3 epsilon leu 4 monoclonal antibody single chain scfv 2 scfc bispecific ig single chain scfv scfv scfc antidll3 and anti cd3e 1 982 scfv vh v kappa anti dll3 1 241 vh homo sapiens ighv4 59 01 g49 c 44 96 9 ighd ighj4 01 100 cdrimgt 8 7 12 26 33 51 57 96 107 1 118 15 mer tris tetraglycyl seryl linker 119 133 v kappa homo sapiens igkv3 20 01 91 7 igkj2 01 q120 c 234 90 9 cdr imgt 7 3 9 160 166 184 186 223 231 134 241 6 mer seryl tetraglycyl seryl linker 242 247 scfv vh v lambda anticd3e 248 496 vh mus musculus ighv10 1 02 91 9 ighd ighj3 01 86 7 homo sapiens ighv3 73 01 87 0 ighd ighj5 01 100 cdr imgt 8 10 16 273 280 298 307 346 361 248 372 15 mertris tetraglycyl seryl linker 373 387 v lambda homo sapiens iglv7 43 01 85 1 iglj3 02 100 cdr imgt 9 3 9 413 421 439 441 478 486 388 496 4 mer tetraglycyl linker 497 500 scfc h ch2 ch3 hch2 ch3 501 982 homo sapiens ighg1 03 h ch2 ch3 ng1m1 hinge 6 15 501 510 ch2 r83 c 572 n84 4 g 577 v85 c 582 511 620 ch3 e12 636 m14 638 621 725 chs del 501 725 30 merhexakis tetraglycyl seryl linker 726 755 homo sapiens ighg1 03 h ch2 ch3 ng1m1 hinge 6 15 756 765 ch2 r83 c 827 n84 4 g 832 v85 c 837 766 875 ch3 e12 891 m14 893 876 980 chs 981 982 756 982 produced in chinese hamster ovary cho cells nonglycosylated
- Immunoglobulin scFv-scFv-scFc, anti-[Homo sapiens DLL3 (delta-like ligand 3)] and anti-[Homo sapiens CD3E (CD3 epsilon, Leu-4)], monoclonal antibody single chain (scFv)2-scFc, bispecific; IG single chain scFv-scFv-scFc, antiDLL3 and anti-CD3E (1-982) [scFv-VH-V-kappa anti-DLL3 (1-241) [VH (Homo sapiens IGHV4-59*01 G49>C (44) (96.9%) -(IGHD) -IGHJ4*01 (100%)) CDRIMGT [8.7.12] (26-33.51-57.96-107) (1-118) -15-mer-tris(tetraglycyl-seryl) linker (119-133) -V-KAPPA (Homo sapiens IGKV3-20*01 (91.7%) -IGKJ2*01 Q120>C (234) (90.9%)) CDR-IMGT [7.3.9] (160-166.184-186.223-231) (134-241)] -6-mer-seryl-tetraglycyl-seryl linker (242-247) -scFv-VH-V-lambda antiCD3E (248-496) [VH (Mus musculus IGHV10-1*02 (91.9%) -(IGHD) -IGHJ3*01 (86.7%)/Homo sapiens IGHV3-73*01 (87.0%) -(IGHD) -IGHJ5*01 (100%)) CDR-IMGT [8.10.16] (273-280.298-307.346-361) (248-372)-15-mertris(tetraglycyl-seryl) linker (373-387) -V-LAMBDA (Homo sapiens IGLV7-43*01 (85.1%) -IGLJ3*02 (100%)) CDR-IMGT [9.3.9] (413-421.439-441.478-486) (388-496)] -4-mer-tetraglycyl linker (497-500) - scFc (h-CH2-CH3)-(hCH2-CH3) (501-982) [Homo sapiens IGHG1*03 h-CH2-CH3, nG1m1 (hinge 6-15 (501-510), CH2 R83>C (572), N84.4>G (577), V85>C (582) (511-620), CH3 E12 (636), M14 (638) (621-725), CHS>del) (501-725) -30-merhexakis(tetraglycyl-seryl) linker (726-755) -Homo sapiens IGHG1*03 h-CH2-CH3, nG1m1 (hinge 6-15 (756-765), CH2 R83>C (827), N84.4>G (832), V85>C (837) (766-875), CH3 E12 (891), M14 (893) (876-980), CHS (981-982)) (756-982)]], produced in Chinese hamster ovary (CHO) cells, nonglycosylated
- Immunoglobulin, anti-(human notch ligand DLL3) (human monoclonal daeldhwzv-1 single-chain variable fragment VH1-(GGGGS)3-VL1) fusion protein with peptide linker (GGGGS) fusion protein with immunoglobulin anti-(human CD3 antigen ε-chain) (human monoclonal daeld-hwzv-1 single-chain variable fragment VH2-(GGGGS)3-VL2) fusion protein with peptide linker (GGGG) fusion protein with immunoglobulin G1 (human γ1-chain C-region C-terminal fragment) fusion protein with peptide linker (GGGGS)6 fusion protein with immunoglobulin G1 (human γ1-chain C-region C-terminal fragment)
- tarlatamab
- Tarlatamab
- tarlatamab [INN]
- Tarlatamab [MI]
- TARLATAMAB [USAN]
- Tarlatamab [WHO-DD]
- tarlatamab dlle
- Tarlatamab dlle [WHO-DD]
- tarlatamab dlle who dd
- tarlatamab inn
- tarlatamab mi
- tarlatamab usan
- tarlatamab who dd
- Tarlatamab-dlle
- ATC classification codes
- L01FX33
Sources for recorded values
- CAS registry numbers
- 2307488-83-9
- ChEMBL ID
- CHEMBL5095292
- FDA ingredient codes (UNII)
- 74X82ST8Q1
- 2682954
- 2682955
- Applicant
- AMGEN INC
- Approval date
- 16 May 2024
- Application number
- BLA761344
- Status
- Authorised
- Status date
- 29 May 2026
- Authorisation date
- 29 May 2026
- Approved indications
- Imdylltra is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.
- Product number
- EMEA/H/C/006451
- Authorisation holder
- Amgen Europe B.V.
- 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
- Small Cell Lung Carcinoma
European medicines record
- Patents
- 0
- Designations
- 5
- Earliest recorded loss of exclusivity
- 1 Jun 2036
- 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
- Pharmacology name
- tarlatamab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- Delta-like protein 3 binding agent
- Action type
- BINDING_AGENT
- Target
- Delta-like protein 3
- Protein identifier
- Q9NYJ7
- 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
- delta like canonical Notch ligand 3
- Gene symbol
- delta like canonical Notch ligand 3
- Median affinity
- 8.52
- Affinity units
- pKd
- Action
- Binding
- Action type
- Binding
- Target
- CD3e
- Gene symbol
- CD3E
- Protein identifier
- P07766
- Median affinity
- 8.36
- Affinity units
- pKd
- Mechanism
- Delta-like protein 3 binding agent
- Action type
- BINDING AGENT
- Target
- Delta-like protein 3
- 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
- Small Cell Lung Carcinoma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Prostatic Neoplasms, Castration-Resistant
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0008315
- Subject identifier
- D064129
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0008433
- Subject identifier
- D055752
- Condition identifier
- EFO_0000196
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000702
- Condition identifier
- EFO_1001471
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0000402
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002120
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002714
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0002974
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004970
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004986
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004992
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005105
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005447
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0006130
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0006329
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0006411
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0008315
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0008315
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008433
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0008903
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0015277
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0016695
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018177
- Highest recorded phase
- 1
And 3 more, listed on the interactive page.
- NCT03319940
- NCT04885998
- NCT05060016
- NCT05361395
- NCT05740566
- NCT06117774
- NCT04702737
- Dose
- Step-up dose 1 mg on Cycle 1 Day 1, then 10 mg on Days 8 and 15 of Cycle 1, and then 10 mg on Day 1 and 15 of subsequent cycles
- Route
- Intravenous
- How often
- Every 2 weeks until disease progression or unacceptable toxicity
- Administer as a 1-hour infusion
- Monitor from start of infusion for 22-24 hours on Cycle 1 Days 1 and 8
- Remain within 1 hour of healthcare setting for 48 hours after Cycle 1 Day 1 and 8 doses
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Sequence
- Type
- Protein
- Sequence
- QVQLQESGPGLVKPSETLSLTCTVSGGSISSYYWSWIRQPPGKCLEWIGYVYYSGTTNYNPSLKSRVTISVDTSKNQFSLKLSSVTAADTAVYYCASIAVTGFYFDYWGQGTLVTVSSGGGGSGGGGSGGGGSEIVLTQSPGTLSLSPGERVTLSCRASQRVNNNYLAWYQQRPGQAPRLLIYGASSRATGIPDRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYDRSPLTFGCGTKLEIKSGGGGSEVQLVESGGGLVQPGGSLKLSCAASGFTFNKYAMNWVRQAPGKGLEWVARIRSKYNNYATYYADSVKDRFTISRDDSKNTAYLQMNNLKTEDTAVYYCVRHGNFGNSYISYWAYWGQGTLVTVSSGGGGSGGGGSGGGGSQTVVTQEPSLTVSPGGTVTLTCGSSTGAVTSGNYPNWVQQKPGQAPRGLIGGTKFLAPGTPARFSGSLLGGKAALTLSGVQPEDEAEYYCVLWYSNRWVFGGGTKLTVLGGGGDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYGSTYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGGGGSGGGGSGGGGSGGGGSGGGGSGGGGSDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYGSTYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKS
- Component
- Disulfide bridges
- Sequence
- 22-95 $ 44-234 $ 156-222 $ 269-345 $ 409-477 $ 506-761 $ 509-764 $ 541-601 $ 572-582 $ 647-705 $ 796-856 $ 827-837 $ 902-960
Related records
Trials (38)
- A Multicenter Phase II Trial to Evaluate Rechallenge With Platinum-based Chemotherapy (Carboplatin, Etoposide) for Progression During Tarlatamab Therapy in Relapsed Extensive Disease Small-cell Lung Cancer (SCLC)
- A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)
- A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC
- A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
- A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer
- A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)
- A Study of Tarlatamab for People With Prostate Cancer
- A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
- A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2
- AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
- Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage Small Cell Lung Cancer and Extrapulmonary Neuroendocrine Cancer
- Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Small Cell Lung Cancer Patients From Adenocarcinoma After EGFR TKI Treatment
- Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors
- Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients
- First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
- Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)
- Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors
- Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab
- Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
- Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
Approved for (2)
- Neoplasm
- Small cell lung carcinoma
In development for (3)
- Metastatic prostate carcinoma Phase 2
- Neuroendocrine carcinoma Phase 3
- Prostate cancer Phase 1