The Babak Lab shared a post on LinkedIn:
“FDA approves Hernexeos (zongertinib) for HER2-mutated NSCLC
The FDA has granted accelerated approval to zongertinib (Hernexeos) for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain activating mutations, detected by an FDA-authorized test.
Key Focus
Zongertinib is a HER2-targeted tyrosine kinase inhibitor, offering a precision oncology option for patients with HER2-mutant NSCLC.
Key Insights
- Approval based on the Beamion LUNG-1 trial in advanced HER2-mutant NSCLC.
- ORR: 76% among 72 evaluable patients.
- Durable responses: 64% lasted ≥6 months and 44% ≥12 months.
- Once-daily oral targeted therapy continued until progression or unacceptable toxicity.
Conclusion
This accelerated approval expands targeted therapy options for HER2-mutant NSCLC, a molecular subgroup with historically limited treatment options.
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