Boehringer Receives FDA Approval for Zongertinib in HER2-Mutant Advanced NSCLC Treatment
Thursday, February 20, 2025
Boehringer Ingelheim has announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to its new drug application for zongertinib (BI 1810631).
Lung cancer remains a leading cause of cancer-related deaths, with cases expected to exceed three million globally by 2040. NSCLC is the most prevalent form of lung cancer, often diagnosed at advanced stages due to a lack of early symptoms and frequent misdiagnoses. The disease significantly affects quality of life, including physical, psychological, and emotional well-being.
HER2 (ERBB2) mutations occur in approximately 2–4% of NSCLC cases and are associated with poor prognosis and a higher risk of brain metastases. These mutations result in increased HER2 (ERBB2) activity, which can contribute to uncontrolled cell growth and cancer progression. There remains a substantial need for new treatment options to address these challenges.
Zongertinib (BI 1810631) is an investigational, irreversible tyrosine kinase inhibitor (TKI) specifically targeting HER2 (ERBB2) while minimising EGFR-related toxicities.
The drug is intended for adults with unresectable or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations who have previously undergone systemic therapy.
The approval shortens the standard review period from ten months to six. A decision under the Prescription Drug User Fee Act (PDUFA) is expected in the third quarter of 2025.
Zongertinib demonstrated a manageable safety profile, with dose reductions required in 5% of cases and treatment discontinuations in 3%. The most common treatment-related adverse events (TRAEs) were diarrhoea (51%) and rash (27%), mainly mild in nature.
No new safety concerns were identified, and only one patient experienced a grade 3 or higher TRAE. There were no reported cases of treatment-related interstitial lung disease (ILD).
The FDA had previously granted Breakthrough Therapy Designation and Fast Track Designation to zongertinib.
In addition, Japan’s Pharmaceuticals and Medical Devices Agency has awarded the drug Orphan Drug Designation.
These designations aim to expedite drug development for serious conditions where initial clinical evidence suggests substantial improvement over existing treatments.
Source: boehringer-ingelheim.com
