Paolo Tarantino: DB-06 Approval Summary by FDA
Paolo Tarantino, 2025 Yvonne’s “Top Voice” Award Winner, Associate Editor for Breast Cancer at ESMO Open, shared a post on X about a recent article by Asma Dilawari et al. published in Journal of Clinical Oncology:
“DB-06 approval summary, by U.S. FDA published in Journal of Clinical Oncology.
Several interesting considerations, including the unexpected PFS HR 1.02 in the 11% of patients enrolled in North America.
The FDA acknowledges the need to understand the activity of T-DXd in HER2-null.”
Title: US Food and Drug Administration Approval Summary: Trastuzumab Deruxtecan for the Treatment of Adult Patients With Hormone Receptor–Positive, Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2–Low or Human Epidermal Growth Factor Receptor 2–Ultralow Breast Cancer
Authors: Asma Dilawari, Hui Zhang, Mirat Shah, Xin Gao, Mallorie Fiero, Vishal Bhatnagar, William Pierce, Bronwyn Mixter, Richard Pazdur, Laleh Amiri-Kordestani
Read the Full Article on Journal of Clinical Oncology
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