Thermo Fisher’s companion diagnostic enables precision treatment with zongertinib for rare NSCLC subset
The FDA approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic for zongertinib, the first targeted therapy specifically indicated for HER2-mutated non-squamous non-small cell lung cancer (NSCLC).
The approval builds on zongertinib’s recent breakthrough designation after demonstrating a 75% objective response rate in heavily pretreated patients in the Beamion LUNG-1 trial. The Oncomine multi-gene panel can now identify NSCLC patients harboring HER2 tyrosine kinase domain (TKD) mutations who are candidates for zongertinib treatment.
Precision Oncology Milestone: This represents a significant advance in lung cancer precision medicine, addressing patients with HER2 mutations who previously had limited targeted therapy options. HER2-mutated NSCLC represents approximately 2-3% of all lung cancers, creating a meaningful but specialized patient population.
The Oncomine Dx platform is now cleared in over 20 countries for numerous biomarkers, facilitating global rollout of precision cancer therapies. A Phase 3 trial (Beamion LUNG-2) is ongoing to potentially move zongertinib into first-line therapy settings.
