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News
The FDA has granted accelerated approval to sevabertinib (Hyrnuo) as a first-line treatment for adults with locally advanced or metastatic non-squamous NSCLC harboring HER2 tyrosine kinase domain activating mutations. Based on the SOHO-01 trial (n=69), the drug achieved an impressive 75% objective response rate. It becomes only the second HER2-targeted oral TKI approved in the US for this indication, following zongertinib.
The FDA has granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals) as a first-line treatment for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors carry HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations — detectable by an FDA-authorized test. This expands the drug's existing second-line indication and makes it only the second oral HER2 TKI approved in the US for this setting, after zongertinib (Hernexeos).
The approval was based on Cohort F of the single-arm, phase 1/2 SOHO-01 trial, which enrolled 69 previously untreated patients (median age 66; 61% female). Patients received sevabertinib 20 mg orally twice daily with food until disease progression or unacceptable toxicity.
By the Numbers:
Why it matters: For patients with HER2-mutated NSCLC — a historically hard-to-treat subset — having a well-tolerated oral first-line option with a 75% response rate is a meaningful step forward. Continued approval hinges on confirmatory trial results.
