FDA expands Bayer’s Hyrnuo into first-line HER2-mutant lung cancer

On Sept. 9, 2026, the FDA granted accelerated approval to Bayer’s Hyrnuo (sevabertinib) as a first-line treatment for adults with locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) harboring HER2/ERBB2 tyrosine-kinase-domain activating mutations, as determined by an FDA-authorized test.

Hyrnuo is an oral reversible HER2-targeted tyrosine-kinase inhibitor. It had previously received accelerated U.S. approval in November 2025 for patients whose disease had already received systemic treatment.

The frontline expansion was supported by interim SOHO-01 data:
reported objective response rate was 75%, including 6% complete responses. As an accelerated approval, continued authorization is contingent on confirmatory evidence.

The decision intensifies competition with Boehringer Ingelheim’s Hernexeos (zongertinib), another oral HER2 inhibitor. Hernexeos entered the first-line setting in February 2026, supported by Beamion LUNG-1 data reporting a 76% response rate in treatment-naïve patients.

The commercial and clinical contest will likely turn on tolerability, durability of response, CNS activity, confirmatory-trial outcomes, pricing and access. Reported cross-trial efficacy is broadly similar, while some coverage has suggested Hernexeos may have a tolerability advantage, particularly regarding severe diarrhea; these are not head-to-head comparisons.