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Enhertu is a prescription HER2-directed antibody-drug conjugate containing fam-trastuzumab deruxtecan-nxki. Current U.S. indications include selected HER2-positive early and metastatic breast cancers, HER2-low or HER2-ultralow metastatic breast cancer, HER2-mutant non-small cell lung cancer, HER2-positive gastric cancer, and selected HER2-positive unresectable or metastatic solid tumors.
read more about enhertu ...Enhertu combines a humanized anti-HER2 antibody with DXd, a topoisomerase I inhibitor, through a cleavable linker. After binding HER2 on tumor cells, the medicine is internalized and the linker is cleaved inside the cell. Released DXd damages DNA and triggers apoptotic tumor-cell death.
Current labeling covers selected HER2-positive early breast cancer before or after surgery, HER2-positive metastatic breast cancer, HER2-low and HER2-ultralow metastatic breast cancer, HER2-mutant unresectable or metastatic non-small cell lung cancer, HER2-positive locally advanced or metastatic gastric cancer, and previously treated HER2-positive IHC 3+ unresectable or metastatic solid tumors.
Most breast cancer, HER2-mutant lung cancer, and IHC 3+ solid tumor regimens use 5.4 mg per kg by intravenous infusion every three weeks. HER2-positive gastric cancer uses 6.4 mg per kg every three weeks. Selected early breast cancer and first-line HER2-positive metastatic breast cancer regimens use indication-specific sequences or combination therapy.
Enhertu carries boxed warnings for interstitial lung disease or pneumonitis and embryo-fetal toxicity. Grade 2 or higher interstitial lung disease calls for permanent discontinuation. Other serious concerns include neutropenia, reduced left ventricular function, infusion reactions, nausea, and fetal harm. Heart function and blood-cell counts are assessed during therapy.
Enhertu is a HER2-directed antibody-drug conjugate linked to the topoisomerase I inhibitor DXd.
Most metastatic breast cancer regimens use an intravenous infusion once every three weeks.
Yes. The boxed warning covers interstitial lung disease or pneumonitis and embryo-fetal toxicity.
The recommended dose is 6.4 mg per kg by intravenous infusion every three weeks.
ENHERTU (Fam-Trastuzumab Deruxtecan-nxki) Prescribing Information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7e67e73e-ddf4-4e4d-8b50-09d7514910b6. Date Accessed September 29, 2026.
Fam-Trastuzumab Deruxtecan-nxki. https://www.cancer.gov/about-cancer/treatment/drugs/famtrastuzumabderuxtecan-nxki. Date Accessed September 29, 2026.
Fam-Trastuzumab Deruxtecan-nxki Injection: MedlinePlus Drug Information. https://medlineplus.gov/druginfo/meds/a620006.html. Date Accessed September 29, 2026.
FDA Approves Fam-Trastuzumab Deruxtecan-nxki With Pertuzumab for Unresectable or Metastatic HER2-Positive Breast Cancer. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive. Date Accessed September 29, 2026.
FDA Approves Two Separate Indications for Fam-Trastuzumab Deruxtecan-nxki in HER2-Positive Early-Stage Breast Cancer. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-two-separate-indications-fam-trastuzumab-deruxtecan-nxki-her2-positive-early-stage. Date Accessed September 29, 2026.