News|Articles|September 11, 2026

Frontline Sevabertinib Approved in HER2-Mutant NSCLC: Nursing Priorities

Author(s)Alex Biese
Fact checked by: By ONN Staff

The FDA expands accelerated approval for sevabertinib to frontline HER2-mutant NSCLC, highlighting a need for vigilant nursing management of diarrhea.

The FDA has granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.) for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. This decision expands the indication for sevabertinib to frontline treatment-naive patients.