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FDA Approves Zongertinib for HER2-Mutated Lung Cancer in February 2026
The FDA granted accelerated approval to zongertinib (Hernexeos) on February 26, 2026, for treating adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations. This targeted therapy represents a significant advancement for patients with this specific genetic subtype of lung cancer, which requires FDA-authorized testing for proper identification. The approval follows similar HER2-targeted treatments like sevabertinib, indicating growing therapeutic options for genetically-defined lung cancer populations.
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