FDA Approves Hyrnuo (sevabertinib) for Certain NSC Lung Cancer Patients

The drug is now indicated for adult patients with locally advanced or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) TKD activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.¹ 

The US FDA has approved Hyrnuo (sevabertinib), an oral, reversible, tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.¹ 

This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.¹

Regulatory approval for Hyrnuo is based on results from the ongoing Phase I/II SOHO-01 trial.¹

In 2024, the FDA granted Hyrnuo Breakthrough Therapy designation for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy. 

Full prescribing information and safety information is available at Bayer’s website.

^{References 
1.    Hyrnuo (sevabertinib) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; November 2025.}