The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Bayer's HYRNUO™ (sevabertinib), an oral, reversible, small molecule tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors harbor human epidermal growth factor receptor 2 (HER2) tyrosine kinase domain activating mutations and have progressed after at least one prior systemic therapy.

This approval, which followed Priority Review and Breakthrough Therapy Designation, addresses a critical unmet need for patients with HER2-mutant NSCLC, a subset accounting for 2% to 4% of advanced NSCLC cases that typically faces a poor prognosis and limited treatment options.

The accelerated approval was based on robust and durable anti-tumor responses demonstrated in the Phase I/II SOHO-01 trial, which showed an objective response rate (ORR) of 71% (including 2.9% complete responses) among patients naïve to prior HER2 targeted therapy, with a median duration of response (DOR) of 9.2 months. Sevabertinib also demonstrated a manageable safety profile in the trial, with the most common adverse reactions being diarrhea, rash, paronychia, stomatitis, and nausea, and a low discontinuation rate of 3.7%. This milestone, which exemplifies Bayer’s strategy centered on precision drug development, provides a targeted treatment for an estimated 84,000 people globally diagnosed with HER2-mutant NSCLC each year, although continued approval is contingent upon verification of clinical benefit in a confirmatory trial.