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Xiuning Le: Celebrating the FDA Approval of Zongertinib as the First TKI for HER2-Mutant NSCLC

Xiuning Le/X

Aug 13, 2025, 11:36

Xiuning Le: Celebrating the FDA Approval of Zongertinib as the First TKI for HER2-Mutant NSCLC

Xiuning Le, Deputy Section Chief of Thoracic Medical Oncology at MD Anderson Cancer Center, shared a post on LinkedIn about recent paper by John V. Heymach et al., published in NEJM.

“We celebrate FDA approval of zongertinib as the first TKI in HER2-mutant NSCLC.

In previously treated patients without prior anti-HER2 targeted therapies NEJM:

ORR 71%
Duration of Response 14.1 months
PFS 12.4 months
Well-tolerated at 120mg dose.”

Title: Zongertinib in Previously Treated HER2-Mutant Non–Small-Cell Lung Cancer

Authors: John V. Heymach, Gerrina Ruiter, Myung-Ju Ahn, Nicolas Girard, Egbert F. Smit, David Planchard, Yi-Long Wu, Byoung Chul Cho, Noboru Yamamoto, Joshua K. Sabari, Yanqiu Zhao, Hai-Yan Tu, Kiyotaka Yoh, Ernest Nadal, Behbood Sadrolhefazi, Maren Rohrbacher, Ute von Wangenheim, Sabina Eigenbrod-Giese, Jon Zugazagoitia

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Xiuning Le: Celebrating the FDA Approval of Zongertinib as the First TKI for HER2-Mutant NSCLC

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Behbood Sadrolhefazi Byoung Chul Cho David Planchard Egbert F. Smit Ernest Nadal Gerrina Ruiter Hai-Yan Tu John V. Heymach Jon Zugazagoitia Joshua K. Sabari Kiyotaka Yoh Maren Rohrbacher Myung-Ju Ahn Nicolas Girard Noboru Yamamoto Sabina Eigenbrod-Giese Ute von Wangenheim Xiuning Le Yanqiu Zhao Yi-Long Wu

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