Bayer expanded access for its HER2 lung cancer therapy Hyrnuo (sevabertinib), receiving accelerated approval for first-line treatment. The FDA authorization extends use to adults with locally advanced or metastatic nonsquamous disease carrying human epidermal growth factor receptor 2 tyrosine kinase domain activating mutations. In parallel, Amgen’s tarlatamab (Imdelltra) plus AstraZeneca’s durvalumab (Imfinzi) met the primary overall survival endpoint in a Phase III first-line maintenance study for extensive-stage small-cell lung cancer, marking a key clinical derisking milestone. Together, the developments tighten the sequencing competition across HER2-driven solid tumors and first-line SCLC strategies—areas where payer and guideline decisions can change quickly once OS data or label expansions appear.