Louisville, Kentucky — November 25, 2025 — Leads & Copy — Onco360®, a leading independent Specialty Pharmacy, has been selected by Bayer Pharmaceuticals as the national pharmacy partner for HYRNUO® (sevabertinib), recently approved by the FDA for treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations.
Benito Fernandez, Chief Commercial Officer, expressed pride in the partnership with Bayer Pharmaceuticals and highlighted HYRNUO as a significant advancement for patients with HER2-mutated NSCLC.
HYRNUO functions as a reversible kinase inhibitor of human epidermal growth factor receptor 2 (HER2), inhibiting phosphorylation of HER2, downstream signaling in cancer cells, and the proliferation of cancer cells with HER2 alterations or TKD-activating mutations.
The FDA’s accelerated approval was based on the Phase I/II SOHO-01 study (NCT05099172), which evaluated HYRNUO’s efficacy and safety in patients with previously treated locally advanced or metastatic NSCLC with HER2. The trial reported a 71% objective response rate in 70 patients who had prior systemic therapy but not HER2-targeted therapy. The median duration of response was 9.2 months, with 54% of responders experiencing a duration of response exceeding 6 months.
HYRNUO’s safety profile included a 3.7% permanent discontinuation rate due to adverse reactions. Common adverse reactions (greater than 20%) included diarrhea, rash, paronychia, stomatitis, and nausea.
Onco360, founded in 2003, is the largest independent Oncology Pharmacy, providing clinical support services and dispensing nationally through its accredited Oncology Pharmacies. Headquartered in Louisville, Kentucky, Onco360 is a specialty pharmacy brand of PharMerica Corporation.
For further details, contact Benito Fernandez, Chief Commercial Officer, at Benito.fernandez@onco360.com or 516-640-1332.
References:
HYRNUO® (sevabertinib) [Package Insert]. Whippany, NJ. Bayer HealthCare Pharmaceuticals. 2025.
Broderick, Jason M. FDA Approves Sevabertinib in HER2-Mutated Nonsquamous NSCLC. Targeted Oncology, 19 Nov 2025.
Contact: Benito Fernandez, Chief Commercial Officer Benito.fernandez@onco360.com 516-640-1332
Source: Onco360®
