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Enhertu

FAM-TRASTUZUMAB DERUXTECAN-NXKI

Manufacturer: Daiichi Sankyo Inc.

Score: 141.0

Quick Summary

Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate used for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, HER2-low breast cancer, HER2-mutant non-small cell lung cancer, HER2-positive gastric cancer, and other HER2-positive solid tumors. The drug has shown efficacy in clinical trials, but it also carries important safety risks, including interstitial lung disease and embryo-fetal toxicity. Dosing recommendations vary by condition, and special population considerations include use during pregnancy, nursing, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer
  • Treatment of adult patients with unresectable or metastatic HER2-low breast cancer
  • Treatment of adult patients with unresectable or metastatic HER2-mutant non-small cell lung cancer
  • Treatment of adult patients with locally advanced or metastatic HER2-positive gastric cancer
  • Treatment of adult patients with unresectable or metastatic HER2-positive solid tumors

Important Safety Information

Warning

Interstitial lung disease and embryo-fetal toxicity

Contraindications

Adverse Reactions

  • Nausea
  • Decreased white blood cell count
  • Decreased hemoglobin
  • Decreased neutrophil count
  • Fatigue
  • Decreased lymphocyte count
  • Decreased platelet count
  • Increased aspartate aminotransferase
  • Increased alanine aminotransferase
  • Vomiting
  • Alopecia
  • Constipation
  • Decreased appetite
  • Diarrhea
  • Musculoskeletal pain
  • Abdominal pain

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for adverse reactions, including interstitial lung disease, neutropenia, thrombocytopenia, and left ventricular dysfunction

HER2-positive or HER2-low breast cancer, HER2-mutant non-small cell lung cancer, and HER2-positive solid tumors

Adult Dose

5.4 mg/kg every 3 weeks

Pediatric Dose

Not established

HER2-positive gastric cancer

Adult Dose

6.4 mg/kg every 3 weeks

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Use during pregnancy can cause fetal harm
  • Advise patients of the potential risks to a fetus

Nursing Mothers

  • Not recommended for use in nursing mothers

Pediatric Use

  • Safety and effectiveness not established in pediatric patients

Geriatric Use

  • No overall differences in efficacy or safety observed in patients 65 years or older compared to younger patients