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U.S. Food and Drug Administration Accepts Karyopharm’s Supplemental New Drug Application for XPOVIO® (Selinexor) as a Treatment for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Priority Review Granted; User Fee Goal Date Set for June 23, 2020 NEWTON, Mass., Feb. 19, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI),
About this update from Karyopharm Therapeutics Inc.
[{"type":"text","content":"Priority Review Granted; User Fee Goal Date Set for June 23, 2020\nNEWTON, Mass., Feb. 19, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an oncology-focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its supplemental New Drug Application (sNDA) seeking accelerated approval for oral XPOVIO® (selinexor) tablets, the Company’s first-in-class, Selective Inhibitor of Nuclear Export (SINE) compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (RR DLBCL), 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 June 23, 2020 under the Prescription Drug User-Fee Act (PDUFA).\n “We look forward to supporting the FDA through the review process for our second NDA for XPOVIO as there remains significant unmet medical need for patients whose DLBCL has relapsed or is refractory to multiple drug therapies,” said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. “This regulatory milestone for XPOVIO represents another important step towards bringing a novel, oral treatment option with a unique mechanism of action to patients and families in need.” Provided marketing approval is granted by the FDA, Karyopharm plans to commercialize XPOVIO in the U.S. in this second indication by mid-2020. The Company also expects to submit a Marketing Authorization Application to the European Medicines Agency in 2020 requesting conditional approval for XPOVIO in this same indication. Priority Review is granted by the FDA to drugs that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition when compared to standard applications. XPOVIO has received both Orphan Drug and Fast Track designations from the FDA for the treatment for patients with relapsed or refractory DLBCL. About XPOVIO® (selinexor) XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and an...