Boehringer Ingelheim’s Hernexeos Gains Accelerated FDA Nod for Lung Cancer

Boehringer Ingelheim secured accelerated FDA approval for Hernexeos (zongertinib), the first oral HER2-targeted therapy for adults with advanced non-small cell lung cancer harboring HER2 tyrosine kinase domain activating mutations. This approval introduces an alternative to AstraZeneca’s Enhertu ADC in this niche. Alongside, Thermo Fisher’s Oncomine Dx Target Test received FDA clearance as a companion diagnostic to identify eligible NSCLC patients, signaling a coordinated advancement in precision oncology for lung cancer treatment.