Bayer's Hyrnuo Wins FDA First-Line Approval for HER2-Mutated Lung Cancer, Sharpening Rivalry With Hernexeos
- Hyrnuo (sevabertinib) is Bayer's oral, HER2-selective tyrosine kinase inhibitor (TKI).
- The FDA granted accelerated approval expanding Hyrnuo to first-line use in adults with HER2 (ERBB2)-mutated, locally advanced or metastatic non-squamous NSCLC.
- The nod is based on Phase I/II SOHO-01 data showing a 75% objective response rate in treatment-naive patients, with responses lasting over six months in 73% of cases.
- It builds on Hyrnuo's November 2025 accelerated approval for previously treated patients with the same HER2-mutated tumor type.
- Continued approval depends on the ongoing Phase III SOHO-02 trial versus standard of care in treatment-naive patients.
- The move deepens Hyrnuo's rivalry with Boehringer Ingelheim's Hernexeos, which won its own first-line nod in February 2026, as the two oral TKIs vie for the small HER2-mutated NSCLC market.
Bayer is catching up, not leading. Boehringer's Hernexeos already claimed first-line HER2-mutated NSCLC in February 2026 — Hyrnuo's approval today closes that gap rather than opening a new front. Worth noting: this is accelerated approval built on single-arm Phase I/II SOHO-01 data (75% ORR, treatment-naive), with confirmatory Phase III SOHO-02 still reading out. Continued approval — and Bayer's ability to actually compete for first-line share — hinges on that trial beating standard of care head-to-head, not just replicating early response rates. Commercially, first-line access matters more than second-line ever will in a niche indication like this, since most patients get one shot at frontline therapy. If SOHO-02 disappoints, Bayer loses the label it just won; if it reads out clean, expect a genuine two-TKI market with prescribers picking on tolerability and durability data rather than brand.
FDA clears Bayer’s Hyrnuo in first-line lung cancer, amping up Hernexeos rivalry ↗