Enhertu (trastuzumab deruxtecan)
- Region
- 🇪🇺 EU
- Active substance
- trastuzumab deruxtecan
- Company
- Daiichi Sankyo Europe GmbH
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms
- CHMP opinion
- Thu 10 Dec 2020
- EU approval
- Mon 18 Jan 2021
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/005124
- ATC
- L01FD04
- Official record
- www.ema.europa.eu
Indication
Breast cancerHER2-positive breast cancerEnhertu 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 cancerEnhertu 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. Other unresectable or metastatic solid tumours Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options (see sections 4.4 and 5.1; for biomarker-based patient selection, see section 4.2).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.