Fam-Trastuzumab Deruxtecan-nxki
Fam-trastuzumab deruxtecan-nxki is a type of targeted therapy drug called an antibody–drug conjugate. It is a monoclonal antibody that is chemically linked to a topoisomerase I-inhibiting drug called deruxtecan. The monoclonal antibody portion binds to HER2, a protein found in high levels on some cancer cells and causes them to grow. Deruxtecan enters these cells, causing DNA damage that kills them. Fam-trastuzumab deruxtecan-nxki also causes a type of immune reaction that kills surrounding cells.
FDA label information for this drug is available at DailyMed.
Use in Cancer
Fam-trastuzumab deruxtecan-nxki is approved to treat adults with:
- Breast cancer that cannot be removed by surgery or has spread to other parts of the body. It is used:
- in patients with HER2-positive cancer who have received anti-HER2 treatment for metastatic cancer or whose cancer came back during or within 6 months of completing anti-HER2 treatment that was given before or after surgery
- in patients with HER2-low cancer who have received chemotherapy for metastatic cancer or whose cancer came back during or within 6 months of completing chemotherapy that was given after surgery
- in patients with HER2-low or HER2-ultralow cancer that got worse during treatment with one or more hormone therapies for metastatic cancer
- Gastric (stomach) cancer or gastroesophageal junction cancer (a rare type of esophageal cancer) that is HER2 positive and has spread. It is used in patients who have received treatment that included trastuzumab.
- Non-small cell lung cancer that has an abnormal HER2 gene and cannot be removed by surgery or has spread to other parts of the body. It is used in patients who have received systemic therapy.¹
- Solid tumors that are HER2 positive and cannot be removed by surgery or have spread to other parts of the body. It is used in patients who have received systemic therapy and cannot be treated with other therapies.¹
¹This use is approved under FDA’s Accelerated Approval Program. As a condition of approval, confirmatory trial(s) must show that fam-trastuzumab deruxtecan provides a clinical benefit in these patients.
Fam-trastuzumab deruxtecan-nxki is also being studied in the treatment of other types of cancer.
More About Fam-Trastuzumab Deruxtecan-nxki
Definition from the NCI Drug Dictionary - Detailed scientific definition and other names for this drug.
MedlinePlus Information on Fam-trastuzumab Deruxtecan-nxki - A lay language summary of important information about this drug that may include the following:
- warnings about this drug,
- what this drug is used for and how it is used,
- what you should tell your doctor before using this drug,
- what you should know about this drug before using it,
- other drugs that may interact with this drug, and
- possible side effects.
Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This patient information sheet applies only to approved uses of the drug. However, much of the information may also apply to unapproved uses that are being studied.
Research Results and Related Resources
FDA Approves Trastuzumab Deruxtecan for Any HER2-Positive Solid Cancer
Enhertu Marks First Targeted Therapy for HER2-Mutant Lung Cancer
Enhertu Improves Survival for Metastatic “HER2-Low” Breast Cancer
Targeted Therapy to Treat Cancer
Clinical Trials Accepting Patients
Find Clinical Trials for Fam-trastuzumab Deruxtecan-nxki - Check for trials from NCI's list of cancer clinical trials now accepting patients.