BRIEF—Boehringer’s Hernexeos gains NCCN recommendation

German family-owned pharma major Boehringer Ingelheim announced that Hernexeos (zongertinib tablets) has been recommended as a preferred subsequent therapy option for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with ERBB2 (HER2) mutations who received prior systemic therapy in the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for non-small cell lung cancer (Version 8), updated on August 15, 2025

The US Food and Drug Administration (FDA) granted accelerated approval to Hernexeos earlier this month, as the first orally administered, targeted treatment for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. The drug is already available to US patients.

“Hernexeos is a meaningful advancement as the first orally administered treatment targeted for HER2-mutant non-small cell lung cancer. The update to the NCCN guidelines gives oncologists further confidence in prescribing it to these patients with unmet need,” said Vicky Brown, senior vice president and head of immunology, oncology, and eye health, Boehringer Ingelheim.