FDA Grants Priority Review to Supplemental NDA for HYRNUO® (sevabertinib) Under Investigation in 1L HER2-Mutated NSCLC
“The U.S. FDA’s decision to grant Priority Review for HYRNUO is an important milestone as we continue to study this investigational treatment option in HER2-mutated non-small cell lung cancer. We look forward to working closely with regulatory authorities as they review the data supporting this application for use in the first-line setting”, said Christian Rommel, Ph.D. , Head of Research and Development at Bayer’s Pharmaceuticals Division.
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