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U.S. FDA Grants Priority Review to Supplemental New Drug Application for HYRNUO® (sevabertinib) Under Investigation as a First-Line Treatment of HER2-Mutated Non-Small Cell Lung Cancer

WHIPPANY, N.J., May 18, 2026--U.S. FDA Grants Priority Review to sNDA for HYRNUO® (sevabertinib) Under Investigation as a First-Line Treatment of HER2-Mutated NSCLC

articleMerck & Company, Inc.May 18, 202612/company/merck-and-company-inc/news/us-fda-grants-priority-review-to-supplemental-new-drug-application-for-hyrnuor-sevabertinib-under-investigation-as-a-first-line-treatment-of-her2-mutated-non-small-cell-lung-cancer
U.S. FDA Grants Priority Review to Supplemental New Drug Application for HYRNUO® (sevabertinib) Under Investigation as a First-Line Treatment of HER2-Mutated Non-Small Cell Lung Cancer

About this update from Merck & Company, Inc.

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lung cancerFood and Drug AdministrationHYRNUOnon-small cell lung cancerBayer