ANTENGENE-B (06996): The application for the market approval of two new indications for Xevior has been approved by the Thai Food and Drug Administration.

date
23/09/2024
avatar
GMT Eight
ANTENGENE-B (06996) announced that the Food and Drug Administration of Thailand has approved the new drug application (NDA) for Xpovio (selinexor tablets) for two indications: (1) in combination with bortezomib and dexamethasone for the treatment of relapsed refractory multiple myeloma (MM) adult patients who have received at least one prior therapy; and (2) in combination with dexamethasone for the treatment of relapsed refractory MM adult patients who have received at least four prior therapies, including at least two proteasome inhibitors, two immunomodulatory agents, and one anti-CD38 monoclonal antibody, and whose disease has worsened during or after their last therapy. It is reported that Xpovio is the world's first approved nuclear export protein oral selective XPO1 inhibitor. It has a novel mechanism of action, synergistic effects in combination therapy, rapid onset of action, and long-lasting response.

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