The U.S. Food and Drug Administration (FDA) granted accelerated approval for Bayer's cancer drug Hyrnuo (sevabertinib). This expanded indication allows Hyrnuo as a first-line treatment for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) featuring a specific HER2 mutation.
The approval transitions Hyrnuo from a therapy for previously treated patients to an initial treatment option. The FDA based its decision on results from the SOHO-01 clinical trial.
The trial demonstrated a 75% objective response rate in treatment-naive patients. This provides an earlier, targeted oral therapy for a patient group with a historically poor prognosis.