Betta Pharmaceuticals (SHE: 300558), a pharmaceutical company based in China, has announced that the market filing for its ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor co-developed with its affiliate Xcovery, has been accepted for review by the US Food and Drug Administration (FDA). The drug is intended for the first-line treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
Ensartinib initially received market approval in China in November 2020 as a second-line treatment for ALK-positive NSCLC and was subsequently included in the National Reimbursement Drug List (NRDL) in December 2021. Further expanding its indications, the drug gained market approval in China for the first-line treatment of ALK-positive locally advanced or metastatic NSCLC in March 2022.- Flcube.com
