U.S. FDA Grants Accelerated Approval to Bayer’s HYRNUO® (sevabertinib) as a First-Line Targeted Therapy for Patients with HER2-Mutated Non-Small Cell Lung Cancer

U.S. FDA Grants Accelerated Approval to Bayer’s HYRNUO® (sevabertinib) as a First-Line Targeted Therapy for Patients with HER2-Mutated Non-Small Cell Lung Cancer

First-line approval of HYRNUO® (sevabertinib) for patients with advanced HER2-mutated non-small cell lung cancer (NSCLC) follows U.S. Food and Drug Administration (FDA) Priority Review and Breakthrough Therapy Designation

Approval is based on results from the ongoing Phase I/II SOHO-01 trial evaluating the efficacy and safety of HYRNUO in patients with advanced HER2-mutated NSCLC

Bayer announced today that following Priority Review and Breakthrough Therapy Designation, the U.S. Food and Drug Administration (FDA) has granted accelerated approval for HYRNUO® (sevabertinib), for the first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.1 HYRNUO is an oral, reversible, small molecule, tyrosine kinase inhibitor (TKI).

The FDA approved this indication for HYRNUO under accelerated approval based on objective response rate (ORR) and duration of response (DOR) demonstrated in treatment-naïve patients (N=69, Cohort F) in the ongoing Phase I/II SOHO-01 trial (NCT05099172).1 The trial is evaluating the efficacy and safety in patients with locally advanced or metastatic non-squamous HER2-mutated NSCLC.1 In this cohort, the ORR was 75% (95% CI: 64, 85; N=69) including complete responses in 6% (n=4) of patients and partial responses in 70% (n=48) of patients, with 73% of responders maintaining response for at least six months and 38% maintaining response for at least 12 months.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing Phase III SOHO-02 confirmatory trial (NCT06452277), which is evaluating HYRNUO versus standard of care in treatment-naïve patients with advanced HER2-mutated NSCLC.