The FDA Has Granted Accelerated Approval to Zongertinib – The Babak Lab
The Babak Lab shared a post on LinkedIn:
“Clinical Mondays: Targeting HER2 in NSCLC – Now in Pill Form
The FDA has granted accelerated approval to zongertinib (Hernexeos) – the first oral HER2-targeted TKI – for adults with unresectable or metastatic non-squamous NSCLC harboring HER2 TKD activating mutations, following prior systemic therapy (Aug 8, 2025).
Study Focus
Develop an oral, HER2-specific tyrosine kinase inhibitor to treat a rare and hard-to-target NSCLC subtype, providing an alternative to IV-based therapies.
Key Insights
• 75% response rate in patients without prior HER2-targeted therapy
• 44% response rate in those previously treated with HER2 ADCs
• 58% maintained response ≥6 months
• Approved companion diagnostic: Oncomine Dx Target Test
Conclusion
Zongertinib offers a new precision medicine tool for HER2-positive NSCLC, expanding treatment options for a population with limited alternatives.”
Maria Babak, Head of The Babak Lab and Assistant Professor at City University of Hong Kong, shared The Babak Lab’s post, adding:
“Zongertinib got FDA approval this week — first oral option for HER2+ NSCLC. Good to see more tools showing up for tough cases!”
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