The U.S. FDA has granted regular approval to Enhertu® (fam-trastuzumab deruxtecan-nxki) as a treatment for unresectable or metastatic HER2-positive breast cancer in adults who have received a prior anti-HER2-based regimen (in the metastatic setting or in the neoadjuvant or adjuvant setting) and have developed disease recurrence during or within six months of completing therapy.

• Enhertu initially received accelerated approval for this indication in Continued approval was contingent upon the results of confirmatory trials. Enhertu won regular approval based on data from the DESTINY-Breast03 randomized trial.
• The drug is also approved to treat locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in adults.
• Recommended dosing for breast cancer is 5.4mg/kg administered via intravenous infusion once every three weeks (21-day cycle) until disease progression or unacceptable toxicity occur.