Is Enhertu approved by the FDA?

Yes, Enhertu (fam-trastuzumab deruxtecan) is FDA approved. The U.S. Food and Drug Administration (FDA) first approved Enhertu on December 20, 2019, for the treatment of HER2-positive breast cancer. The approval was based on its effectiveness in treating adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received two or more anti-HER2-based regimens.

What is Enhertu?

Enhertu is a targeted therapy known as a HER2-directed antibody and topoisomerase inhibitor conjugate. It combines two cancer-fighting agents: a monoclonal antibody (fam-trastuzumab) and a chemotherapy drug (topoisomerase I inhibitor). Enhertu works by blocking HER2 receptors on cancer cells, preventing their multiplication and growth, and then delivering chemotherapy directly to the cancer cells to damage or kill them.

Uses of Enhertu

Enhertu is approved for multiple cancer indications:

1. Breast Cancer:
   • HER2-positive breast cancer that cannot be surgically removed (unresectable) or has spread (metastatic) and has already been treated with anti-HER2-based regimens.
   • HER2-low breast cancer that is unresectable or metastatic and has progressed following chemotherapy.
2. Gastric Cancer:
   • HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma that has spread locally or to other parts of the body after prior trastuzumab-based treatment.
3. Non-Small Cell Lung Cancer (NSCLC):
   • NSCLC with HER2 (ERBB2) mutations that are unresectable or metastatic and have progressed following systemic therapy.
4. Solid Tumors:
   • HER2-positive solid tumors that are unresectable or metastatic in patients who have received prior systemic treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval contingent on clinical trial results.

Dosage and Administration

Enhertu is administered as an intravenous infusion. The dosing schedule generally involves an infusion every three weeks:

• Unresectable or Metastatic Breast Cancer and Solid Tumors: 5.4 mg/kg IV every three weeks.
• HER2-Mutant NSCLC: 5.4 mg/kg IV every three weeks.
• Gastric Cancer: 6.4 mg/kg IV every three weeks.

The first infusion typically lasts 90 minutes, with subsequent infusions taking around 30 minutes if tolerated well.

Side Effects

Common side effects of Enhertu include:

• Nausea and vomiting
• Diarrhea or constipation
• Cough
• Fever
• Fatigue
• Low blood cell counts
• Hair loss

Serious side effects may include:

• Lung problems (e.g., shortness of breath, cough)
• Heart issues (e.g., pounding heartbeats, swelling)
• Low potassium levels (e.g., muscle weakness, irregular heartbeats)
• Infusion reactions

Patients should be monitored for side effects, and treatment may be paused or discontinued if severe reactions occur.

Warnings and Precautions

• Pregnancy and Breastfeeding: Enhertu can harm an unborn baby. Effective contraception is required during treatment and for seven months after the last dose for women, and for four months after the last dose for men. Breastfeeding is not recommended during treatment and for seven months post-treatment.
• Immune System: Enhertu can suppress the immune system, increasing infection and bleeding risks. Patients should report unusual bruising, bleeding, or signs of infection to their healthcare provider.
• Heart and Lung Health: Patients with heart problems or lung conditions should inform their healthcare provider before starting treatment.

Conclusion

Enhertu (fam-trastuzumab deruxtecan) is an FDA-approved targeted therapy for certain HER2-positive cancers, including breast cancer, gastric cancer, and non-small cell lung cancer. Its approval on December 20, 2019, marked a significant advancement in the treatment of these cancers.

How to obtain the latest development progress of all drugs?

In the Synapse database, you can stay updated on the latest research and development advances of all drugs. This service is accessible anytime and anywhere, with updates available daily or weekly. Use the "Set Alert" function to stay informed. Click on the image below to embark on a brand new journey of drug discovery!