FDA expands indication for Bayer’s Hyrnuo

The US Food and Drug Administration (FDA) yesterday granted accelerated approval for German pharma major Bayer’s (BAYN: DE) Hyrnuo (sevabertinib), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.

The FDA noted thar this approval expands the existing indication for sevabertinib, which was previously granted accelerated approval for adult patients with locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations who had received prior systemic therapy.