Reported Earlier, Bayer's HYRNUO Wins First-Line FDA Approval For HER2-Mutated Lung Cancer, Following Priority Review And Breakthrough Therapy Designation
First-line approval of HYRNUO® (sevabertinib) for patients with advanced HER2-mutated non-small cell lung cancer (NSCLC) follows U.S. Food and Drug Administration (FDA) Priority Review and Breakthrough Therapy Designation
Approval is based on results from the ongoing Phase I/II SOHO-01 trial evaluating the efficacy and safety of HYRNUO in patients with advanced HER2-mutated NSCLC
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