The US FDA has granted accelerated approval to Bayer's sevabertinib (Hyrnuo) for the frontline treatment of adult patients with locally advanced or metastatic HER2-mutant non-small cell lung cancer (NSCLC). Supported by the Phase 1/2 SOHO-01 trial showing a 75% objective response rate, this approval expands targeted options for a rare mutation affecting 2% to 3% of NSCLC patients. However, clinical integration requires strict nursing vigilance, as diarrhea occurs in up to 90% of patients, with 16% experiencing severe Grade 3 toxicity.
FDA accelerated approval expansion
- ▪The September 9, 2026 FDA approval expands the indication of sevabertinib to frontline use in treatment-naive patients, whereas it was previously approved only for pretreated patients
- ▪The US Food and Drug Administration granted accelerated approval to sevabertinib, marketed as Hyrnuo by Bayer Healthcare Pharmaceuticals Inc., for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer harboring HER2 tyrosine kinase domain activating mutations
HER2-mutant NSCLC biomarker
- ▪HER2 mutations represent a distinct, rare subset of non-small cell lung cancers, occurring in approximately 2% to 3% of patients
- ▪With the expanded approval of sevabertinib, there are currently three targeted therapies holding FDA approval for frontline administration in the HER2-mutant non-small cell lung cancer population, consisting of two oral agents and one intravenous antibody-drug conjugate
SOHO-01 trial efficacy data
- ▪Among responding patients in the SOHO-01 trial, 73% maintained a duration of response of 6 months or longer, and 38% maintained a duration of response of 12 months or longer
- ▪In the open-label, single-arm, multicenter, multi-cohort Phase 1/2 SOHO-01 trial of 69 treatment-naive patients, sevabertinib demonstrated a confirmed objective response rate of 75%
Diarrhea management protocols
- ▪Managing Grade 3 diarrhea associated with sevabertinib requires holding administration of the drug and executing a dose reduction upon clinical resolution
- ▪Diarrhea occurs in 85% to 90% of patients receiving twice-daily oral sevabertinib, with 16% of patients developing Grade 3 diarrhea, defined as an increase of 7 or more stools per day over baseline
Nursing toxicity monitoring
- ▪Beth Sandy, MSN, CRNP, FAPO, of Penn Medicine's Abramson Cancer Center, stated that integrating sevabertinib into frontline practice requires structured nursing vigilance to manage treatment-associated toxicities effectively
- ▪The prescribing information for sevabertinib contains warnings for hepatotoxicity, interstitial lung disease or pneumonitis, left ventricular dysfunction, ocular toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity
Patient counseling strategies
- ▪Oncology nurses must counsel patients taking sevabertinib to report changes in bowel habits immediately to prevent severe dehydration and maintain therapeutic continuity
- ▪Essential nursing interventions for patients taking sevabertinib include initiating antidiarrheal therapy at the first loose stool and maintaining adequate oral hydration
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