Bayer HealthCare Pharmaceuticals has secured expanded FDA accelerated approval for sevabertinib, sold as Hyrnuo, targeting previously untreated HER2-mutated non-small cell lung cancer patients.
The U.S. Food and Drug Administration granted the expanded label on September 9, 2026, covering adults with locally advanced or metastatic non-squamous NSCLC harbouring HER2 tyrosine kinase domain activating mutations.
Sevabertinib is an oral, HER2-selective tyrosine kinase inhibitor that first received accelerated approval on November 19, 2025, for patients who had already undergone prior systemic therapy.
The first-line expansion marks a significant commercial milestone for Bayer, positioning Hyrnuo earlier in the treatment pathway for a defined group of lung cancer patients.
The FDA grounded its decision in data from the single-arm, phase 1/2 SOHO-01 trial, which enrolled 69 patients with HER2 tyrosine kinase domain activating mutations who had not previously received systemic therapy.
Results from the trial showed an objective response rate of 75%, with a 95% confidence interval ranging from 64% to 85%, representing a strong signal in this biomarker-defined population.
Durability of response was also notable, with 73% of patients maintaining a response for at least six months and 38% sustaining a response for at least one year.
Continued approval for the first-line indication may be contingent on verification and description of clinical benefit in a confirmatory trial, the FDA noted.
The recommended dose is 20 mg orally twice daily with food, taken as whole tablets and continued until disease progression or unacceptable toxicity occurs.
HER2 kinase domain activating mutations, most commonly exon 20 insertions, account for roughly 2% to 4% of all non-small cell lung cancer cases, making them a relatively rare but clinically important target.
Bayer faces competition in this space from Boehringer Ingelheim, which presented data at the European Society of Medical Oncology congress showing a 77% objective response rate for its own treatment in first-line patients, compared to Bayer’s reported 71% in the same population.
Boehringer Ingelheim has already secured an FDA breakthrough therapy designation for Hernexeos in the first-line setting, intensifying the race to establish the standard of care in HER2-mutated lung cancer.