The FDA granted accelerated approval to zongertinib (Hernexeos) on February 26, 2026, for adults with unresectable or metastatic non-squamous non-small cell lung cancer harboring HER2 tyrosine kinase domain activating mutations. This approval requires tumor testing via an FDA-authorized diagnostic. HER2 mutations occur in roughly 2–4% of NSCLC cases and have historically lacked dedicated targeted therapies. Zongertinib joins a small but growing class of HER2-directed agents, offering oncologists a precision option for this molecularly defined subgroup. The accelerated approval pathway signals promising early efficacy data, though confirmatory trials will be required to verify clinical benefit. This represents a meaningful advance for patients whose tumors carry this specific alteration.
