PFS Data Support Approval of Fam-Trastuzumab Deruxtecan-nxki for HER2+ Breast Cancer

Yeon Hee Park, MD, discusses the data supporting the FDA’s accelerated approval of fam-trastuzumab deruxtecan-nxki for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.

Yeon Hee Park, MD, professor, Breast Cancer Center, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, discusses the data supporting the FDA’s accelerated approval of fam-trastuzumab deruxtecan-nxki (Enhertu; DS-8201) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.

This decision was based on updated data from the phase II DESTINY-Breast01 trial, which were presented at the 2019 San Antonio Breast Cancer Symposium. The agent demonstrated a median progression-free survival (PFS) of 16.4 months in this study, says Park. According to a subgroup analysis of this study, which was recently presented at the 2020 European Society for Medical Oncology (ESMO) Breast Cancer Virtual Meeting, the agent also induced a median PFS of 18.1 months among patients with brain metastases.

Overall, these are very positive findings for a very heavily pretreated group of patients, according to Park. Patients in this study had a median of 6 prior lines of therapy. Because of this long stabilization of disease in a very heavily pretreated patient population, trastuzumab deruxtecan was approved by the FDA for the treatment of these patients.

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