Loading Curie Briefs...
Getting the latest healthcare news for you
Getting the latest healthcare news for you
The FDA has granted accelerated approval to sevabertinib (Hyrnuo) as a frontline treatment for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 mutations. Based on the phase 1/2 SOHO-01 trial, the drug showed an impressive 75% objective response rate. This expands on its existing approval for patients who had already received systemic therapy.
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) — specifically in patients whose tumors carry HER2 tyrosine kinase domain activating mutations. This marks an expansion of the drug's existing indication, which previously covered patients who had already undergone systemic therapy.
The approval was based on results from the single-arm, phase 1/2 SOHO-01 trial involving 69 treatment-naïve patients. Sevabertinib is taken orally at 20 mg twice daily until disease progression or unacceptable toxicity.
By the Numbers:
Why it matters: HER2-mutant NSCLC is a historically difficult-to-treat subset of lung cancer with limited frontline targeted options. Sevabertinib's strong response rates in treatment-naïve patients could meaningfully shift the standard of care for this population, giving oncologists a new precision medicine tool right from the start of treatment.
