KPTI - Karyopharm/Antengene files South Korean application for ATG-010 in blood cancer

Antengene submits a New Drug Application ((NDA)) in South Korea for ATG-010 (selinexor, XPOVIO) in combination with low dose dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (rrMM) and for ATG-010 as monotherapy for treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL).The NDA submission includes positive data from the pivotal STORM and SADAL studies, which both demonstrated significant and meaningful efficacy with a manageable safety profile for ATG-010. Antengene is conducting two registrational Phase 2 clinical trials of ATG-010 in China for rrMM ((MARCH)) and for rrDLBCL ((SEARCH)).ATG-010 was granted orphan drug tag in South Korea in October 2020 and U.S. partner Karyopharm Therapeutics (KPTI) received FDA approval for treatment of multiple myeloma on December 18, 2020.

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Karyopharm/Antengene files South Korean application for ATG-010 in blood cancer