Datopotamab deruxtecan
Highest phase reached
Phase 3
Drug type
Antibody drug conjugate
- Listing at source
- Listed
- Highest phase reached
- Phase 3
- Drug type
- Antibody drug conjugate
- Drug name
- Datopotamab deruxtecan
- adc ds 1062a
- ADC DS-1062A
- anti trop2 dxd antibody drug conjugate ds 1062a
- ANTI-TROP2/DXD ANTIBODY-DRUG CONJUGATE DS-1062A
- dato dxd
- Dato-DXd
- datopotamab deruxtecan
- Datopotamab deruxtecan
- Datopotamab Deruxtecan
- Datopotamab deruxtecan (Dato-DXd)
- Datopotamab Deruxtecan (Dato-DXd)
- datopotamab deruxtecan [INN]
- DATOPOTAMAB DERUXTECAN [USAN]
- Datopotamab deruxtecan [WHO-DD]
- datopotamab deruxtecan dlnk
- Datopotamab deruxtecan dlnk [WHO-DD]
- datopotamab deruxtecan dlnk who dd
- datopotamab deruxtecan inn
- datopotamab deruxtecan usan
- datopotamab deruxtecan who dd
- Datopotamab Deruxtecan-DLNK
- Datopotamab deruxtecan-dlnk (Dato-DXd)
- datroway
- DATROWAY
- ds 1062
And 11 more, listed on the interactive page.
- ATC classification codes
- L01FX35
Sources for recorded values
- CAS registry numbers
- 2238831-60-0
- ChEMBL ID
- CHEMBL4297939
- RxNorm IDs (RxCUI)
- 2703033
- FDA ingredient codes (UNII)
- GD2OWY1DTK
- Status
- Authorised
- Status date
- 4 Apr 2025
- Authorisation date
- 4 Apr 2025
- Approved indications
- Breast cancerDatroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.
- Product number
- EMEA/H/C/006547
- Authorisation holder
- Daiichi Sankyo Europe GmbH
- 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
- Breast Neoplasms
European medicines record
- Patents
- 0
- Designations
- 2
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Pharmacology name
- datopotamab deruxtecan
- Type
- Antibody
- Drug name stem
- -mab; -tecan
- Approval recorded by Guide to Pharmacology
- Yes
- Mechanism
- Tumor-associated calcium signal transducer 2 binding agent
- Action type
- BINDING_AGENT
- Target
- Tumor-associated calcium signal transducer 2
- Protein identifier
- P09758
- Action
- Binding
- Action type
- Binding
- Target
- tumor associated calcium signal transducer 2
- Gene symbol
- TACSTD2
- Protein identifier
- P09758
- Mechanism
- DNA topoisomerase I inhibitor
- Action type
- Inhibitor
- Target
- DNA topoisomerase 1
- Protein identifier
- P11387
- Mechanism
- Tumor-associated calcium signal transducer 2 binding agent
- Action type
- BINDING AGENT
- Target
- Tumor-associated calcium signal transducer 2
- Mechanism
- DNA topoisomerase I inhibitor
- Action type
- Inhibitor
- Target
- DNA topoisomerase 1
- Condition
- Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003869
- Subject identifier
- D001943
- Condition
- Hemangiosarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003968
- Subject identifier
- D006394
- Condition
- Triple Negative Breast Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005537
- Subject identifier
- D064726
- Condition
- Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0004992
- Subject identifier
- D009369
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0007254
- Subject identifier
- D001943
- Condition
- Lung Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0008903
- Subject identifier
- D008175
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003863
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003869
- Condition identifier
- MONDO_0001056
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002447
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002974
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0003060
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005140
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005233
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005494
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005575
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0006003
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0006047
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0007254
- Condition identifier
- MONDO_0007254
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0007576
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0008170
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008315
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008433
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0008903
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0009831
- Highest recorded phase
- 1
And 7 more, listed on the interactive page.
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- Prodrug
- No
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QVQLVQSGAEVKKPGASVKVSCKASGYTFTTAGMQWVRQAPGQGLEWMGWINTHSGVPKYAEDFKGRVTISADTSTSTAYLQLSSLKSEDTAVYYCARSGFGSSYWYFDVWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Disulfide bridges
- Sequence
- 22-96 22''-96'' $ 23'-88' $ 23'''-88''' $ 134'-194' $ 134'''-194''' $ 148-204 $ 148''-204'' $ 224-214' $ 224''-214''' $ 230-230'' $ 233-233'' $ 265-325 $ 265''-325'' $ 371-429 $ 371''-429''
- Component
- Light chain
- Type
- Protein
- Sequence
- DIQMTQSPSSLSASVGDRVTITCKASQDVSTAVAWYQQKPGKAPKLLIYSASYRYTGVPSRFSGSGSGTDFTLTISSLQPEDFAVYYCQQHYITPLTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Glycosylation sites (N)
- Sequence
- 451 $ 451''
- 65597-801
Related records
Trials (47)
- A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
- A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
- A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features
- A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
- A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)
- A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors
- A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors
- A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)
- A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
- A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)
- A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)
- A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer
- A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
- A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
- A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors
- A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer
- A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC
- An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer.
- DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
In development for (8)
- Angiosarcoma Phase 2
- Breast cancer Phase 3
- Breast neoplasm Phase 3
- Cancer Phase 3
- Lung cancer Phase 2
- Neoplasm Phase 3
- Non-small cell lung carcinoma Phase 3
- Triple-negative breast carcinoma Phase 2