Drug Administration and Eligibility
The FDA has approved Bayer’s oral therapy sevabertinib, which will be marketed as Hyrnuo, for adults with non-squamous non-small cell lung cancer (NSCLC) whose tumors carry HER2 tyrosine kinase domain–activating mutations. The authorization places Bayer in direct competition with Boehringer Ingelheim and AstraZeneca, which also market HER2-targeting treatments for NSCLC.
Hyrnuo is administered as a 20-mg tablet taken twice daily with food. Eligibility is limited to patients who have already received at least one systemic therapy and whose tumor mutations are confirmed through an FDA-approved diagnostic test. The FDA also cleared a companion diagnostic from Life Technologies Corporation to identify individuals who may qualify for the therapy.
Clinical Trial Results
The approval was supported by findings from the Phase I/II SOHO study. Data presented at the 2025 European Society for Medical Oncology meeting showed that patients who had undergone previous systemic treatment—but had not received therapies specifically aimed at HER2—experienced a 64% overall response rate. In this subgroup, median progression-free survival reached 8.3 months.
Among treatment-naïve participants, the drug produced a 71% response rate, with median progression-free survival not yet determined. Patients who had previously been treated with HER2-directed antibody-drug conjugates showed a 38% response rate and a median progression-free survival of 5.5 months.
A separate dataset showed that 71% of 70 patients previously treated for cancer, but not with HER2-targeting therapies, had tumor shrinkage or disappearance when given Hyrnuo. In another cohort of 52 patients with prior systemic therapy, including HER2-directed treatments, 38% experienced reduced tumor size.
Safety and Regulatory Information
Hyrnuo’s prescribing information outlines several safety considerations, including risks of diarrhea, liver toxicity, ocular complications and increases in pancreatic enzyme levels. The drug also received multiple FDA designations, including breakthrough therapy and orphan drug status, and it underwent priority review.
In addition, Hyrnuo was evaluated under Project Orbis, an FDA Oncology Center of Excellence initiative that allows for the “concurrent submission and review of oncology drugs among international partners,” including agencies in Canada, Israel and the U.K.
Market Competition and Pricing
The monthly list price for Hyrnuo is $24,000. Its entry into the market intensifies competition with Boehringer Ingelheim’s Hernexeos, another kinase inhibitor approved in August for the same HER2-mutated NSCLC population. Both therapies were cleared through the FDA’s accelerated approval pathway.
Bayer commented on the authorization. Chandrasekhar Goda, an executive at the company, said the approval “provides a welcome addition to the treatment space.” Goda also noted the relevance of the therapy for patients with advanced disease.
NSCLC is described as the most common form of lung cancer, representing around 80% to 85% of diagnosed cases. The FDA stated that Hyrnuo is intended for patients with advanced or metastatic disease that has progressed after earlier treatments.
Additional Insights
The approval of Hyrnuo is expected to have a significant impact on treatment guidelines for HER2-mutated NSCLC. Experts note that the high response rates in previously untreated patients highlight the potential of targeted oral therapies, giving oncologists a new option to manage this aggressive form of lung cancer. Moreover, the FDA’s endorsement of both the therapy and the companion diagnostic reflects a broader trend in precision oncology, emphasizing the importance of biomarker-driven treatment strategies.
Patients and physicians are closely watching post-market safety and real-world effectiveness, as the therapy enters wider clinical use. Hyrnuo’s approval is also expected to stimulate additional research into combination approaches with immunotherapies and other kinase inhibitors, potentially expanding its role in NSCLC treatment beyond current indications.
Looking ahead, analysts expect Hyrnuo’s approval to intensify competition in the HER2-mutated NSCLC market and potentially drive further innovation in oral targeted therapies. The FDA’s backing not only validates the clinical benefits observed in trials but may also encourage ongoing studies exploring Hyrnuo in combination with immunotherapies or as a first-line option.
