Karyopharm Therapeutics (NASDAQ:KPTI) has submitted a New Drug Application (NDA) to the FDA seeking accelerated approval for XPOVIO (selinexor), an oral Selective Inhibitor of Nuclear Export (SINE) compound, 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.
Karyopharm also expects to submit a marketing authorization application to the European Medicines Agency in 2020 requesting conditional approval for XPOVIO in this same indication.
Shares are up 2% premarket.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.