The Center for Drug Evaluation (CDE) in China has granted Breakthrough Therapy Designation (BTD) to German pharmaceutical giant Bayer (ETR: BAYN)’s drug candidate BAY 2927088 for the treatment of HER2 mutant non-small cell lung cancer (NSCLC), as indicated on the CDE’s official website. This marks a significant regulatory milestone for Bayer, following a similar designation awarded by the U.S. Food and Drug Administration (FDA) in February of this year for the tyrosine kinase inhibitor (TKI).
The BTD in China underscores the drug’s potential to address a significant unmet medical need in the treatment of HER2 mutant NSCLC, a difficult-to-treat subset of lung cancer. The tyrosine kinase inhibitor BAY 2927088 targets the HER2 pathway, which is implicated in the growth and survival of certain cancer cells.- Flcube.com
