Huadong Medicine Co., Ltd (SHE: 000963), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its filing for market approval of mefatinib. The drug is proposed as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with an L858R replacement mutation in exon 21 of the epidermal growth factor receptor (EGFR).
Mefatinib, a second-generation irreversible EGFR/HER2 inhibitor developed in-house, is known for its high activity and water solubility. In 2015, Huadong Medicine secured a licensing deal with Metabomics, Inc., acquiring the rights for mefatinib in China. The drug received approval for the treatment of advanced solid tumors in China in October 2014. Last May, it was granted a breakthrough therapy designation (BTD) for the treatment of first-line advanced NSCLC with rare EGFR mutations (S768I, L861Q, and G719X) in China. A Phase III study demonstrated the drug’s superiority in first-line advanced non-squamous NSCLC with EGFR sensitive mutations compared to gefitinib.- Flcube.com
