Posted by Michael Wonder on 19 Feb 2020
U.S. FDA accepts Karyopharm’s supplemental new drug application for Xpovio (selinexor) as a treatment for patients with relapsed or refractory diffuse large B cell lymphoma
19 February 2020 - Priority review granted; user fee goal date set for 23 June 2020.
Karyopharm Therapeutics today announced that the U.S. FDA has accepted for filing its supplemental new drug application seeking accelerated approval for oral Xpovio (selinexor) tablets, the Company’s first-in-class, Selective Inhibitor of Nuclear Export compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who have received at least two prior therapies.
The FDA also granted Karyopharm’s request for priority review and assigned a user fee goal date of 23 June 2020 under the Prescription Drug User-Fee Act.
