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DATOPOTAMAB
DATOPOTAMAB is a Trop-2-directed antibody-drug conjugate drug. It is currently in Phase 1 development.
12.1 Mechanism of Action Datopotamab deruxtecan-dlnk, is a Trop-2-directed antibody-drug conjugate.
Datopotamab deruxtecan is an antibody drug conjugate that targets tumor-associated calcium signal transducer 2. It is being studied in clinical trials for various conditions, including non-small cell lung cancer, triple negative breast cancer, stomatitis, and advanced solid tumors.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | DATOPOTAMAB |
|---|---|
| Drug class | Trop-2-directed antibody-drug conjugate |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | Phase 1 |
Mechanism of action
12.1 Mechanism of Action Datopotamab deruxtecan-dlnk, is a Trop-2-directed antibody-drug conjugate. The antibody is a humanized anti-Trop2 IgG1. The small molecule, DXd, is a topoisomerase I inhibitor attached to the antibody by a cleavable linker. Following binding to Trop-2 on cells, including tumor cells, datopotamab deruxtecan-dlnk undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Upon release, the membrane-permeable DXd causes DNA damage and apoptotic cell de
Approved indications
Common side effects
Key clinical trials
- A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in Subjects With No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non- (Phase 3)
- A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab Deruxtecan (T-DXd) in Patients With Metastatic HER2-negative (HER2-low or HER2-0) Breast Cancer After Progression o (Phase 2)
- A Phase Ib/II, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relaps (Phase 1)
- A Phase 1 Dose-Escalation Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamic Activity of CLN-619 (Anti-MICA/MICB Antibody) Alone and in Combination With Pembrolizumab in (Phase 1)
- Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer (Phase 2)
- A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metas (Phase 3)
- A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-lin (Phase 3)
- A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With (Phase 2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DATOPOTAMAB CI brief — competitive landscape report
- DATOPOTAMAB updates RSS · CI watch RSS
- portfolio CI
Frequently asked questions about DATOPOTAMAB
What is DATOPOTAMAB?
How does DATOPOTAMAB work?
What drug class is DATOPOTAMAB in?
What development phase is DATOPOTAMAB in?
Related
- Drug class: All Trop-2-directed antibody-drug conjugate drugs
- Manufacturer: — full pipeline
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing