Karyopharm submits NDA for Xpovio as DLBCL treatment

27 December 2019

Cancer-focused Karyopharm Therapeutics (Nasdaq: KPTI) has submitted a New Drug Application (NDA) to the US Food and Drug Administration seeking accelerated approval for Xpovio (selinexor), the company’s first-in-class, oral selective inhibitor of nuclear export (SINE) compound.

The drug is intended as a new treatment for patients with relapsed or refractory diffuse large B-Cell lymphoma (DLBCL) after at least two prior multi-agent therapies and who are ineligible for stem cell transplantation, including CAR-T (chimeric antigen receptor modified T cell) therapy.

Xpovio has received both Orphan Drug and Fast Track designations from the FDA for this indication. Karyopharm also expects to submit a marketing authorization application (MAA) to the European Medicines Agency in 2020 requesting conditional approval for Xpovio in this same indication.

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