Boehringer Ingelheim, a leading German pharmaceutical company, has received a significant endorsement from China’s Center for Drug Evaluation (CDE) with the breakthrough therapy designation (BTD) for its investigational HER2-targeted tyrosine kinase inhibitor (TKI), zongertinib (BI 1810631). This designation underscores the potential of zongertinib in treating adult patients with HER2-mutated advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) who have previously undergone systemic treatment.
China’s involvement in the clinical development of zongertinib dates back to the Phase Ia study, a testament to Boehringer Ingelheim’s China Key strategy, which emphasizes the country’s integral role in global clinical research. Zongertinib is also a key component of the global, multi-center Phase III Beamion LUNG-2 study, which aims to evaluate the efficacy and safety of zongertinib compared to the standard of care for patients with HER2-mutant locally advanced or metastatic non-squamous NSCLC.- Flcube.com
