Hyrnuo accelerated approval for HER2-mutated NSCLC

What this means

About 2-4% of non-small cell lung cancers (NSCLC) are driven by mutations in a specific region (the tyrosine kinase domain) of the HER2 gene. These mutations are different from the HER2 protein over-expression seen in breast and gastric cancer, and they define a distinct subset of patients with limited targeted-therapy options. HYRNUO (sevabertinib) is Bayer's oral pill that selectively blocks the mutant HER2 protein driving these tumors. It first received FDA accelerated approval for this population after prior systemic therapy; on September 9, 2026 the FDA granted a further accelerated approval that removes the prior-therapy requirement, letting doctors use HYRNUO as a first-line treatment in adults with locally advanced or metastatic non-squamous NSCLC when an FDA-authorized companion diagnostic confirms the HER2 mutation. The expansion is based on 69 previously-untreated patients in Cohort F of the SOHO-01 Phase I/II trial, where 75% saw their tumors shrink (6% complete responses, 70% partial), with 73% of responders keeping the benefit for at least six months and 38% for at least a year. Because this was an accelerated approval, continued approval will depend on Bayer confirming clinical benefit in ongoing confirmatory trials.