Bayer expanded access for Hyrnuo (sevabertinib) by securing an accelerated approval for first-line treatment in patients with locally advanced or metastatic HER2-mutated non-squamous non-small-cell lung cancer. The expanded indication builds on the label granted in November for previously treated patients. Clinicians are likely to weigh Hyrnuo earlier in the treatment pathway for this biomarker-defined population. Separately, broader regulatory and clinical trial dynamics remain choppy for oncology drugs, underscoring how quickly development programs can shift based on trial outcomes and subsequent label expansions.