Trastuzumab Deruxtecan 100mg
| Product Overview | |
| Generic Name | Trastuzumab Deruxtecan 100mg |
| Brand Name(s) | Enhertu® |
| Form | Lyophilized Powder for concentrate for solution for infusion |
| Strength | 100mg (20mg/mL on 5mL vial) |
| Therapeutic Class | HER2-targeted monoclonal antibody–drug conjugate antineoplastic |
| ATC Code | L01FD04 |
| Manufacturing & Regulatory | |
| Manufacturer | Daiichi Sankyo, AstraZeneca |
| Country | Europe |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | 058M2023 SSA |
| Free Sale Certificate | Available from supplier on request |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 36 months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Upon Request, not publicly posted |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
Trastuzumab deruxtecan is a HER2-targeted antibody–drug conjugate comprising a humanized anti-HER2 IgG1 monoclonal antibody linked to a topoisomerase-I inhibitor payload (DXd). Indicated for: unresectable or metastatic HER2-positive breast cancer after prior HER2-directed therapy; HER2-low breast cancer (IHC 1+ or 2+/ISH–); HER2-mutant unresectable or metastatic NSCLC; HER2-positive gastric/gastro-oesophageal junction adenocarcinoma after trastuzumab-based therapy; and HER2-positive (IHC 3+) unresectable or metastatic solid tumours lacking satisfactory alternatives
