Posted by Michael Wonder on 24 Dec 2019
Karyopharm submits new drug application to U.S. FDA for Xpovio (selinexor) as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma
23 December 2019 - Karyopharm Therapeutics today announced it has submitted a new drug application to the U.S. FDA seeking accelerated approval for Xpovio (selinexor), the Company’s first-in-class, oral Selective Inhibitor of nuclear export compound, as a new treatment for patients with relapsed or refractory diffuse large B-cell lymphoma 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 authorisation application to the European Medicines Agency in 2020 requesting conditional approval for Xpovio in this same indication.
