FDA approves selinexor for relapsed/refractory diffuse large B-cell lymphoma

FDA

22 June 2020 - Today the Food and Drug Administration granted accelerated approval to selinexor (Xpovio, Karyopharm Therapeutics) for adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.

Approval was based on SADAL (KCP-330-009), a multicenter, single-arm, open-label trial in patients with DLBCL after 2 to 5 systemic regimens. Patients received selinexor 60 mg orally on days 1 and 3 of each week. 

Read FDA press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US