Antengene submitted yesterday (1/3) a New Drug Application (NDA) with Orphan Drug Designation (ODD) to South Korea’s regulatory body, the Ministry of Food and Drug Safety (MFDS), for ATG-010 (selinexor). The NDA is specifically for the approval of ATG-010 (selinexor) to be taken with a low dose of dexamethasone to treat adult patients that have relapsed or refractory myeloma. In October 2020, ATG-010 (selinexor) was approved as a monotherapy for relapsed or refractory diffuse large B-cell lymphoma in adults.
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