U.S. FDA Grants Accelerated Approval to Bayer’s HYRNUO® (sevabertinib) as a First-Line Targeted Therapy for Patients with HER2-Mutated Non-Small Cell Lung Cancer

The U.S. FDA granted accelerated approval to Bayer’s HYRNUO (sevabertinib) as a first-line targeted treatment for patients with HER2-mutated non-small cell lung cancer (NSCLC). The approval creates a new commercial opportunity for Bayer in precision oncology, though the accelerated pathway typically requires confirmatory clinical evidence.