Onco-Summaries: Daily Oncology Updates at a Glance

03/09/2025

Boehringer Ingelheim's zongertinib received the FDA Breakthrough Therapy Designation for first-line HER2-mutant advanced NSCLC (Ref)

The US FDA granted the Breakthrough Therapy Designation to Boehringer Ingelheim's zongertinib (HERNEXEOS; HER2-selective tyrosine kinase inhibitor) for the first-line treatment of adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 tyrosine kinase domain activating mutations.

• Vicky Brown, Senior Vice President and Head of Immunology, Oncology, and Eye Health, Boehringer Ingelheim: "Exploring accelerated review pathways is part of Boehringer's strategy to have an unprecedented and generational impact on people facing cancer. We are incredibly pleased that HERNEXEOS has received Breakthrough Therapy Designation for first-line use in patients living with HER2-mutant non-small cell lung cancer. This pathway was designed to expedite the development and review of promising medicines for serious diseases, and clearly highlights the potential of HERNEXEOS."