Hyrnuo® (sevabertinib)
November 20, 2025
FOR IMMEDIATE RELEASE:
Onco360® Has Been Selected as The National Specialty Pharmacy Partner for HYRNUO® (sevabertinib)
Louisville, KY — November 20, 2025 — Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as the national pharmacy partner by Bayer Pharmaceuticals for HYRNUO® (sevabertinib). The Food and Drug Administration approved HYRNUO 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
“HYRNUO represents a meaningful therapeutic advancement for patients living with HER2-mutated non-small cell lung cancer,” said Benito Fernandez, Chief Commercial Officer. “We are proud of our long-standing partnership with Bayer Pharmaceuticals and honored by the trust placed in our organization as the national specialty pharmacy partner for HYRNUO.”
HYRNUO is a reversible kinase inhibitor of human epidermal growth factor receptor 2 (HER2). In vitro, HYRNUO inhibited the phosphorylation of HER2, downstream signaling in cancer cells with HER2 alterations, and the proliferation of cancer cells overexpressing wild-type HER2 or harboring HER2 tyrosine kinase domain-activating mutations.1
This indication received accelerated approval based on the Phase I/II SOHO-01 study (NCT05099172), which assessed the efficacy and safety of HYRNUO in patients with previously treated locally advanced or metastatic NSCLC with human epidermal growth factor receptor 2 (HER2).2 The trial demonstrated an objective response rate of 71% in a population of 70 patients who had prior systemic therapy but had not received HER2-targeted therapy. The median duration of response (DOR) in these patients was 9.2 months, and 54% of responders had a DOR of more than 6 months.2
HYRNUO demonstrated a manageable safety profile with a 3.7% permanent discontinuation rate due to an adverse reaction. In the pooled safety population, the most common (> 20%) adverse reactions were diarrhea, rash, paronychia, stomatitis, and nausea.1
Please read the full prescribing information for HYRNUO.
Media Contact: Benito Fernandez, Chief Commercial Officer
516-640-1332
References:
1HYRNUO® (sevabertinib) [Package Insert]. Whippany, NJ. Bayer HealthCare Pharmaceuticals. 2025.
2Broderick, Jason M. FDA Approves Sevabertinib in HER2-Mutated Nonsquamous NSCLC. Targeted Oncology, 19 Nov 2025.