Shots:
- The US FDA has granted Priority Review to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic NSCLC harboring HER2 (ERBB2) TKD-activating mutations & no prior systemic therapy
- sNDA was supported by preliminary data from Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo in treatment-naïve pts with locally advanced or metastatic HER2-mutated NSCLC
- In Nov 2025, Hyrnuo received accelerated approval from the US FDA for previously treated pts with locally advanced or metastatic NSCLC harboring HER2 TKD-activating mutations, based on ORR & DoR data from the P-I/II (SOHO-01) trial
Ref: Businesswire | Image: Bayer | Press Release
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