Enhertu is a medicine used for treating adults with: - HER2-positive breast cancer that is metastatic (has spread to other parts of the body) or cannot be removed by surgery. HER2-positive means that the cancer cells produce a protein called HER2 in large quantities on their surface, which makes the tumour cells grow more quickly. Enhertu is used on its own in patients who have received one or more HER2-targeted treatments; - HER2-low and HER2-ultralow breast cancer that is metastatic or cannot be removed by surgery. HER2-low and HER2-ultralow means that the cancer cells produce some HER2 on their surface, but less than HER2-positive cancer cells. It is used on its own in patients when the cancer cells have receptors for certain hormones on their surface (HR-positive). It is used in patients who have previously received at least one endocrine therapy (treatment which blocks the effect of oestrogens, a female sex hormone) for metastatic breast cancer and who are not considered for endocrine therapy for their next treatment; - HER2-low breast cancer in patients whose disease is metastatic or cannot be removed by surgery, and who have previously received chemotherapy after the disease had spread or whose disease came back during or within 6 months of treatment following surgery. Enhertu is used on its own; - advanced non-small cell lung cancer (NSCLC) whose cancer cells have a mutation (change) in the gene for the HER2 protein, called an activating HER2 mutation. It is used on its own in patients who had previously been treated with platinum-based chemotherapy with or without immunotherapy (treatment that boosts the immune system’s ability to fight the cancer); - HER2-positive advanced gastric cancer (cancer of the stomach) or gastro-oesophageal junction cancer (cancer at the junction between the stomach and the oesophagus). It is used on its own in patients who have previously received trastuzumab, another HER2-targeted treatment. Enhertu contains the active substance trastuzumab deruxtecan.
Therapeutic Indication
### Therapeutic indication Breast cancer HER2-positive breast cancer Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. HER2-low and HER2-ultralow breast cancer Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic \- hormone receptor (HR)-positive, HER2-low or HER2-ultralow 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 (see sections 4.2 and 5.1). \- HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4.2). Non-small cell lung cancer (NSCLC) Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. Gastric cancer Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
Therapeutic Area (MeSH)
ATC Code
L01FD04
ATC Item
trastuzumab deruxtecan
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| trastuzumab deruxtecan | N/A | 德曲妥珠单抗 |
EMA Name
Enhertu
Medicine Name
Enhertu
Aliases
N/ANo risk management plan link.