FDA grants accelerated approval for Bayer HYRNUO sevabertinib in HER2-mutated NSCLC

Bayer said the U.S. Food and Drug Administration granted accelerated approval for HYRNUO (sevabertinib) for first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations. The approval followed Priority Review and Breakthrough Therapy Designation.