FDA Grants Accelerated Approval to Zongertinib for HER2-Mutant Lung Cancer
The FDA granted accelerated approval to zongertinib (Hernexeos) in February 2026 for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 tyrosine kinase domain activating mutations. This approval marks a significant step forward for a patient population that has historically lacked dedicated targeted therapies. HER2 mutations occur in roughly 2–4% of NSCLC cases and are associated with poor prognosis under conventional chemotherapy. Zongertinib is a selective, irreversible HER2 tyrosine kinase inhibitor designed to block the aberrant signaling that drives tumor growth in these patients. Accelerated approval was based on tumor response rate and duration of response data, with confirmatory trials ongoing to verify clinical benefit. This adds a precision oncology option to a rapidly evolving lung cancer treatment landscape.