• XPOVIO is the First and Only Nuclear Export Inhibitor Approved by the FDA
• XPOVIO is the First and Only Prescription Medicine Approved by the FDA for the Treatment of Patients with Multiple Myeloma whose Disease is Refractory to Proteasome Inhibitors, Immunomodulatory Agents, and an Anti-CD38 Monoclonal Antibody
• Karyopharm to Hold an Investor Conference Call and Webcast at 1:30 PM ET Today

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an on­col­ogy-focused pharma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved oral XPOVIOTM (selinexor), a nuclear export inhibitor, in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of adult patients with re­lapsed or refractory multiple myeloma (RRMM) who have received at least four prior ther­a­pies and whose disease is refractory to at least two pro­te­a­some inhibitors, at least two immuno­modu­la­tory agents, and an anti-CD38 mono­clonal anti­body. This indi­ca­tion …

Silver Spring, MD (Press Release) – Today, the U.S. Food and Drug Admin­istra­tion granted accelerated approval to Xpovio (selinexor) tablets in com­bi­na­tion with the corticosteroid dexa­meth­a­sone for the treat­ment of adult patients with re­lapsed refractory multiple myeloma (RRMM) who have received at least four prior ther­a­pies and whose disease is resistant to several other forms of treat­ment, in­clud­ing at least two pro­te­a­some inhibitors, at least two immuno­modu­la­tory agents, and an anti-CD38 mono­clonal anti­body.

“While there is no cure for multiple myeloma, there are FDA-approved treat­ments to target the cancer and slow down …

• PDUFA Action Date Extended by Three Months to July 6, 2019
• FDA Has Requested Additional Existing Information for Review

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for selinexor. The NDA, which is cur­rently under Priority Review by the FDA, is seeking accelerated approval for selinexor in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of patients with re­lapsed refractory multiple myeloma who have received at least three prior ther­a­pies …

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage phar­ma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) Onco­logic Drugs Advisory Committee (ODAC) met to discuss the New Drug Application (NDA) for selinexor, a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) com­­pound. The NDA, which is cur­rently under Priority Review by the FDA, is seeking accelerated approval for selinexor in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of patients with re­lapsed refractory multiple myeloma who have received at least three prior ther­a­pies and whose disease is refractory to …

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Admin­istra­tion (FDA) is scheduled to review data sup­porting the Company’s New Drug Application (NDA) requesting accelerated approval for selinexor, a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) com­pound, at a meeting on February 26, 2019 at 12:30 p.m. ET. The proposed indi­ca­tion to be discussed at this upcoming ODAC meeting is for selinexor in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of patients with refractory …

Selinexor Marketing Authori­za­tion Appli­ca­tion to be Reviewed Under Accelerated Assessment

Newton, MA (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, to­day an­nounced that it has sub­mitted a Mar­ket­ing Authori­za­tion Appli­ca­tion (MAA) to the Euro­pean Medicines Agency (EMA) for selinexor, the Com­pany’s first-in-class, oral Sel­ective Inhibitor of Nuclear Export (SINE) com­pound, re­quest­ing con­di­tional ap­prov­al for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma (MM) who have re­ceived at least three prior lines of ther­apy and whose dis­ease is re­frac­tory to at least one pro­te­a­some in­hib­i­tor (PI), one immuno­modu­la­tory agent (IMiD), and one anti-CD38 mono­clonal anti­body (mAb), and to their …

• Application Seeks Accelerated Approval for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma
• PDUFA Date Set for April 6, 2019

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) seeking accelerated approval for selinexor, its first in class, oral SINE com­­pound, as a new treat­ment for patients with penta-refractory multiple myeloma. The FDA also granted Karyopharm’s request for Priority Review and assigned an action date of April 6, 2019 under the Prescription Drug User-Fee Act (PDUFA). …