LOUISVILLE, Ky., Nov. 24, 2025 (GLOBE NEWSWIRE) -- 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.
About Onco360 Oncology Pharmacy
Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com.
Media Contact: Benito Fernandez, Chief Commercial Officer
Benito.fernandez@onco360.com
516-640-1332
References:
HYRNUO® (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.
