Germany-based Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for zongertinib (BI 1810631). The drug is indicated for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations who have received prior systemic therapy. The FDA is expected to make a decision during the third quarter of this year.
Drug Profile
Zongertinib is an investigational, irreversible tyrosine kinase inhibitor (TKI) that selectively targets HER2 (ERBB2) while sparing EGFR, thereby reducing associated toxicities. The NDA is supported by positive results from the Phase Ib Beamion LUNG-1 study.
Clinical Trial Results
- Cohort 1 (N=75): Showed an objective response rate (ORR) of 71%.
- Six-Month Progression-Free Survival (PFS): 69%.
- Duration of Response (DoR): 73%.
- Safety Profile: Demonstrated a favorable safety profile with no treatment-related interstitial lung disease (ILD) reported.-Fineline Info & Tech
