Antengene Reports NDA Submission for ATG-010 (selinexor) to Treat RRMM and RR DLBCL in South Korea

Shots:

• The NDA is based on STORM and SADAL studies. The P-IIb STORM study involves assessing of ATG-010 + low-dose dexamethasone in patients with rrMM prior treated with at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 mAb
• The P-II SADAL study involves assessing ATG-010 in patients with rrDLBCL, including DLBCL arising from FL, who have received at least 2 prior therapies. The studies demonstrated efficacy with a manageable safety profile for ATG-010
• ATG-010 (Xpovio) is a first-in-class oral SINE and is the first FDA approved drug for use in both MM and DLBCL

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