The Center for Drug Evaluation (CDE) website indicates that China-based Huadong Medicine Co., Ltd (SHE: 000963) is on course to obtain breakthrough therapy designation (BTD) for its mefatinib. This second-generation irreversible EGFR/HER2 inhibitor is targeted for the treatment of first-line advanced non-small cell lung cancer (NSCLC) with rare mutations in epidermal growth factor receptor (EGFR) (S768I, L861Q, and G719X).
Mefatinib: A Second-Generation Inhibitor with High Activity and Solubility
Mefatinib, developed in-house by Huadong Medicine, demonstrates high activity and water solubility, offering significant therapeutic benefits against drug resistance often caused by first-generation EGFR inhibitors. The drug has shown promising results in progression-free survival (PFS) event follow-ups and has completed its last enrollment for a Phase III study in June 2021, with a market filing anticipated during the second quarter of this year.
Implications for NSCLC Treatment and the Healthcare Sector
The potential Breakthrough Therapy Designation for mefatinib signifies a significant step forward in the treatment of NSCLC with EGFR mutations. If granted, this designation will highlight the drug’s potential to offer a more effective treatment option for patients with this specific type of lung cancer, thereby impacting the healthcare sector positively.-Fineline Info & Tech
