Shots:
- The US FDA has granted accelerated approval to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic non-squamous NSCLC harboring HER2/ERBB2 TKD-activating mutations
- Approval was supported by ORR & DoR results from the 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 non-squamousHER2-mutated NSCLC
- In this cohort, Hyrnuo achieved a 75% ORR (N=69), incl. 6% CR (n=4) & 70% PR (n=48); 73% of responders maintained responses ≥6mos. & 38% maintained response ≥12mos. Continued approval depends on confirmatory P-III (SOHO-02) results
Ref: Businesswire | Image: Bayer | Press Release
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