Boehringer Ingelheim Scores FDA Nod for Lung Cancer Drug Hernexeos

Boehringer Ingelheim’s oral HER2-targeted therapy, Hernexeos (zongertinib), gained accelerated approval from the FDA for non-small cell lung cancer patients with specific HER2 activating mutations. It joins a competitive market, offering an alternative to AstraZeneca and Daiichi Sankyo’s Enhertu ADC. Companion diagnostic approval for Thermo Fisher’s Oncomine Dx Target Test enables precise patient selection. The drug is indicated for advanced disease with limited prior systemic therapy options.