The FDA has granted accelerated approval to Bayer’s HYRNUO, or sevabertinib, as a first-line treatment for adults with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors carry activating HER2/ERBB2 tyrosine kinase domain mutations.
Patients must have mutations identified through an FDA-authorized test. Sevabertinib is an oral, reversible small-molecule tyrosine kinase inhibitor.
The approval is based on results from Cohort F of the ongoing Phase I/II SOHO-01 study, which enrolled 69 previously untreated patients with advanced HER2-mutated non-small cell lung cancer.
The cohort recorded an objective response rate of 75%, with a 95% confidence interval of 64% to 85%. Four patients, or 6%, had complete responses, while 48 patients, or 70%, had partial responses.
Among patients who responded, 73% maintained their response for at least six months and 38% maintained a response for at least 12 months.
FDA accelerated approvals can be based on response measures that are reasonably likely to predict clinical benefit. Bayer’s continued approval for this first-line indication may depend on verification and description of clinical benefit in the Phase III SOHO-02 confirmatory trial.
SOHO-02 is comparing sevabertinib with standard care in previously untreated patients with advanced HER2-mutated non-squamous non-small cell lung cancer.
In SOHO-01, the most common adverse reactions reported in more than 20% of the 191 patients who received sevabertinib were diarrhea, rash, stomatitis, paronychia, nausea and decreased weight.
The FDA previously granted accelerated approval to HYRNUO in November 2025 for patients with locally advanced or metastatic non-small cell lung cancer with HER2 tyrosine kinase domain activating mutations who had received prior systemic therapy. That indication also remains subject to confirmatory evidence of clinical benefit.
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