Shots:
- The US FDA has granted accelerated approval to Hyrnuo (BAY 2927088; reversible TKI) under priority review for the treatment of previously treated pts with LA/M NSCLC harboring HER2 tyrosine kinase domain activating mutations; NDA under NMPA’s review
- Approval was based on the ORR & DoR data from the ongoing P-I/II (SOHO-01) trial assessing Hyrnuo (PO) in HER2-mutant NSCLC pts who had disease progression after ≥1 systemic therapy
- Trial showed ORR of 71% (n=70), with CR of 2.9% & PR of 69% as well as mDoR of 9.2mos. (n=50) in pts naïve to HER2 targeted therapy, plus); data was presented at ESMO’25 & published in The NEJM
Ref: Bayer | Image: Bayer | Press Release
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