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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 (ERBB2) tyrosine kinase domain activating mutations. The decision was based on the SOHO-01 trial, where 75% of previously untreated patients responded to the oral HER2 inhibitor. It's only the second drug approved in the US for this specific indication.
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 activating mutations — detectable by an FDA-authorized test. This expands on the drug's existing second-line approval and makes it only the second agent cleared in the US for this indication, following zongertinib (Hernexeos) last year.
The approval was supported by data from the single-arm, phase 1/2 SOHO-01 trial in 69 previously untreated patients. The drug is taken as a 20 mg oral dose twice daily with food until disease progression or unacceptable toxicity.
By the Numbers:
Why it matters: HER2-mutated NSCLC is a difficult-to-treat subset with limited targeted options. Sevabertinib's first-line approval gives oncologists an additional oral, targeted therapy earlier in the treatment journey — potentially improving outcomes for patients who previously had to wait for second-line options. Clinicians should note key warnings including diarrhea, hepatotoxicity, ILD/pneumonitis, left ventricular dysfunction, and ocular toxicity.
