← All approvals · Cancer · 2025
Hernexeos (zongertinib)
The FDA approved Hernexeos (zongertinib) on August 8, 2025 to treat adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
- Brand name
- Hernexeos
- Generic name
- zongertinib
- FDA approval date
- August 8, 2025
- Approved use (FDA wording)
- To treat adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy
- Company
- Boehringer Ingelheim
- Application
- NDA219042
- Dosage form / route
- TABLET · ORAL
- Drug class (EPC)
- Kinase Inhibitor [EPC]
- Boxed warning on label
- Not listed
- Category on this site
- Cancer
Indications and usage, from the FDA label
HERNEXEOS is indicated for the treatment of adult patients 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-authorized test [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. HERNEXEOS is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non…