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 therapy for patients with HER2-mutated non-small cell lung cancer (NSCLC). The approval expands Bayer's oncology portfolio into a genetically defined first-line treatment setting and represents a significant positive regulatory catalyst, although the article provides no sales forecasts or clinical efficacy data.