Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Accelerated Approval for 1L Treatment of Non-Squamous HER2-Mutated NSCLC

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 PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Accelerated Approval for 1L Treatment of Non-Squamous HER2-Mutated NSCLC appeared first on PharmaShots.