Posted by Michael Wonder on 18 May 2026
US 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
18 May 2026 - Regulatory submission for first-line use of Hyrnuo is based on results from the on-going Phase I/II SOHO-01 trial evaluating the efficacy and safety in patients with advanced HER2 mutated non-small cell lung cancer who have not received prior therapy.
Bayer announced today that the US FDA has granted Hyrnuo (sevabertinib) priority review status for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer whose tumours have HER2 (ERBB2) tyrosine kinase domain activating mutations in patients with no prior therapy.
