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INN: trastuzumab deruxtecan
Data updated: 2026-04-25
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About This Product
Manufacturer
User Reviews
Reviews reflect personal experiences and are not medical advice. Always consult your doctor.
Daiichi Sankyo Europe GmbH
ATC Code
L01FD04
Source
EMA · EMEA/H/C/005124
(
ARTG
)
Metastatic breast cancer,HER2-positive,ENHERTU as monotherapy, is indicated for the treatment of adult patients with unresectable or
metastatic HER2-positive breast cancer who previously received:, trastuzumab and a taxane for metastatic disease, or, one prior anti-HER2-based regimen and developed disease recurrence during or within six
months of completing neo-adjuvant or adjuvant therapy.,HER2-low,ENHERTU as monotherapy is indicated for the treatment of adult patients with unresectable or
metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received prior
chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months
of completing adjuvant chemotherapy. Patients with hormone receptor positive (HR+) breast cancer
should additionally have received and no longer be considered eligible for endocrine therapy.,HER2-low and HER2-ultralow,ENHERTU as monotherapy is indicated for the treatment of adult patients with unresectable or
metastatic HR+ and either HER2-low (IHC 1+ or IHC 2+/ISH-negative) or HER2-ultralow (IHC 0
with membrane staining) breast cancer who have received at least one endocrine therapy in the
metastatic setting and who are not considered suitable for endocrine therapy as the next line of
treatment.Locally advanced or metastatic gastric cancer,ENHERTU is indicated for the treatment of adult patients with locally advanced or metastatic
HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a
prior anti-HER2-based regimen. This indication was approved via the provisional approval
pathway based on objective response rate. Continued approval of this indication depends on
verification and description of benefit in a confirmatory trial.,Other unresectable or metastatic solid tumours,ENHERTU is indicated for the treatment of adult patients with unresectable or metastatic HER2-
positive (IHC3+) solid tumours who have received prior systemic treatment and who have no
satisfactory alternative treatment options. This indication was approved via the provisional
approval pathway based on objective response rate. Full registration of this indication depends on
submission of further clinical data to confirm the clinical benefit of the medicine.,Unresectable or metastatic non-small cell lung cancer (NSCLC),ENHERTU is indicated for the treatment of adult patients with unresectable or metastatic NSCLC
whose tumours have activating HER2 (ERBB2) mutations and who have received prior platinumbased
chemotherapy with or without immunotherapy. This indication was approved via the
provisional approval pathway based on objective response rate. Continued approval of this
indication depends on verification and description of benefit in a confirmatory trial.