FDA Approves Zongertinib for HER2

The FDA has granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.) for certain adults with unresectable or metastatic nonsquamous non-small cell lung cancer (NSCLC).

Specifically, the TKI was approved for patients whose tumors harbor HER2 ( ERBB2 ) tyrosine kinase domain-activating mutations as detected by an FDA-approved test and who have received prior systemic therapy, according to the approval notice .

The novel agent is the first orally administered, targeted therapy for previously treated patients with HER2 ( ERBB2 )-mutant NSCLC, who have poor prognosis and limited treatment options, Boehringer Ingelheim noted in a February 2025 press release announcing the agent having been granted priority review. Zongertinib had previousl