The Food and Drug Administration has expanded accelerated approval of Bayer’s cancer drug sevabertinib, sold as Hyrnuo, to adults who have not previously received systemic treatment for a narrowly defined form of advanced non-small cell lung cancer. The September 9 action makes the oral medicine available earlier for patients with locally advanced or metastatic non-squamous NSCLC whose tumors carry specified activating HER2, also called ERBB2, mutations in the tyrosine kinase domain.
The change is significant because Hyrnuo’s prior U.S. accelerated approval was limited to patients who had already received systemic therapy. The expanded use still depends on finding the relevant mutation with an FDA-authorized test, and it does not apply to all people with lung cancer or all forms of non-small cell lung cancer. The FDA based the decision on tumor-response results in a 69-patient cohort, not on a randomized comparison showing that the drug improves survival over another treatment.
Trial results behind the expansion
According to the FDA announcement, the agency evaluated the new use in SOHO-01, a multicenter trial with several patient cohorts. The study was open-label and single-arm: participants received sevabertinib, with no separate randomly assigned control group receiving another treatment. The cohort supporting the expanded indication included 69 people who had not received prior systemic therapy.
Independent reviewers, who assessed scans under the standard RECIST 1.1 tumor-response criteria, found a confirmed objective response rate of 75%. The 95% confidence interval ranged from 64% to 85%, an indication of the statistical uncertainty that comes with the cohort’s size. Objective response means tumors shrank by a predefined amount or disappeared on imaging; it is not a measure of how long patients lived.
Among participants whose tumors responded, the FDA reported that 73% had a response lasting at least six months and 38% had a response lasting at least 12 months. Those duration figures provide some context beyond the response rate, but they apply only to patients who responded. The agency’s summary did not provide overall-survival or progression-free-survival results for this previously untreated cohort.
The findings show antitumor activity in this uncontrolled cohort. They cannot establish how sevabertinib compares with existing first-line treatment approaches, because the trial did not randomly compare it with another medicine or regimen. A 75% response rate also should not be read as a 75% cure rate, nor as evidence that every eligible patient will benefit.
What changed from the 2025 approval
FDA records show that Hyrnuo first received accelerated approval on November 19, 2025, for adults with the same broad disease setting and specified HER2 mutation profile after prior systemic therapy. The agency’s orphan-drug approval record documents that earlier indication, while the new announcement removes the previous-treatment requirement.
In practical terms, the new label moves a biomarker-selected treatment from a later-treatment setting to one available at the outset of systemic care. It remains restricted to adults with non-squamous NSCLC that is locally advanced or metastatic and has the specified HER2 tyrosine kinase domain activating mutations. Tumor testing is therefore part of determining whether a patient fits the indication.
The FDA’s current notice uses the term “FDA-authorized test” for identifying the mutation. Its older orphan-drug database entry described the earlier indication using “FDA-approved test.” The current announcement governs the newly expanded use and is the more relevant description of the testing requirement.
Hyrnuo, made by Bayer Healthcare Pharmaceuticals Inc., is taken at a recommended dose of 20 milligrams by mouth twice daily with food, continuing until disease progression or unacceptable toxicity, according to the FDA. The agency said it conducted its review through Project Orbis, an international oncology-review initiative, in collaboration with the United Kingdom’s Medicines and Healthcare products Regulatory Agency. Reviews were continuing at other regulatory agencies.
Safety concerns remain part of treatment decisions
The FDA label includes warnings and precautions for diarrhea, liver toxicity, interstitial lung disease or pneumonitis, reduced left-ventricular function, eye toxicity, elevated pancreatic enzymes and embryo-fetal toxicity. Interstitial lung disease and pneumonitis involve inflammation or scarring in the lungs; left-ventricular dysfunction concerns the heart’s main pumping chamber. These listed risks mean eligibility based on tumor testing is only one part of the clinical decision.
Accelerated approval allows a drug to reach patients on the basis of the response evidence reviewed by the agency, while leaving important comparative questions unresolved in the FDA’s public summary. For people considering the newly expanded indication, the available regulatory evidence describes how frequently tumors responded and how long many responses persisted, but not whether the treatment extends survival compared with alternatives.
Specialty coverage of the original approval, including reporting by Cancer Therapy Advisor, described Hyrnuo as a treatment for patients previously treated for this molecularly defined cancer. The FDA’s latest decision now changes that treatment-history boundary, while retaining the same precise disease, mutation and testing limits.