FDA Grants Zongertinib Breakthrough Therapy Designation in HER2-Mutant NSCLC

• Zongertinib (BI 1810631), an investigational oral therapy, was granted breakthrough therapy designation (BTD) from the FDA.
• China’s Center for Drug Evaluation (CDE) also granted a BTD for this agent in adult patients with advanced, unresectable or metastatic non–small cell lung cancer (NSCLC) whose tumors have activating HER2 mutations and who have received prior systemic therapy.
• Data from the Beamion LUNG-1 study (NCT04886804) evaluating zongertinib will be presented at the IASLC 2024 World Conference on Lung Cancer (WCLC) on Monday, September 9, 2024.

The FDA granted zongertinib, a HER2-specific tyrosine kinase inhibitor (TKI), BTD for the treatment of adult patients with advanced, unresectable or metastatic NSCLC harboring HER2 mutations who have received a prior systemic therapy. Read more.