KPTI - Antengene submits selinexor application in Taiwan in hematologic malignancies
Karyopharm Therapeutics' (KPTI) partner Antengene has submitted a New Drug Application ((NDA)) to the Taiwan Food and Drug Administration for selinexor, a XPO1 inhibitor, for three indications:In combination with bortezomib and dexamethasone (XVd), or in combination with dexamethasone (Xd) for the treatment of patients with relapsed and/or refractory multiple myeloma ((RRMM)); andAs monotherapy in adult patients with relapsed and/or refractory diffuse large B-cell lymphoma (rrDLBCL), including DLBCL arising from follicular lymphoma, who have received at least two lines of systemic therapy.Antengene has submitted NDAs for selinexor in multiple Asia Pacific markets, and was granted Priority Review status in China and Orphan Drug Designation in South Korea.Antengene and Karyopharm Therapeutics have inked collaboration and license agreement for the development and commercialization of selinexor and other two XPO1 inhibitors, and a PAK4/NAMPT inhibitor in 17 APAC markets including Mainland China.Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for
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Antengene submits selinexor application in Taiwan in hematologic malignancies