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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 Multiple Myeloma After At Least One Prior Line of Therapy
NEWTON, Mass., July 20, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today announced that
About this update from Karyopharm Therapeutics Inc.
[{"type":"text","content":"NEWTON, Mass., July 20, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its supplemental New Drug Application (sNDA) seeking approval for XPOVIO® (selinexor), its first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, as a new treatment for patients with multiple myeloma after at least one prior line of therapy. Karyopharm expects a decision from the FDA regarding this sNDA before the end of the first quarter of 2021.\n “This sNDA acceptance brings us one step closer to providing access to XPOVIO for a significantly larger patient population battling multiple myeloma,” said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. “If approved, we believe XPOVIO will become an important new, oral, once-weekly treatment option, used in combination with once-weekly Velcade®, for patients with multiple myeloma after at least one prior line of therapy. We look forward to working closely with the FDA during their review process and we sincerely thank the many patients, caregivers and physicians whose immense contributions have helped us achieve this latest milestone.” XPOVIO has been previously approved by the FDA for the treatment of patients with penta-refractory multiple myeloma and relapsed or refractory diffuse large B-cell lymphoma. Provided marketing approval is granted by the FDA for this third oncology indication, Karyopharm plans to continue to commercialize XPOVIO in the U.S. using its existing commercial infrastructure. The Company also plans to submit a Marketing Authorization Application to the European Medicines Agency later this year for this same indication. 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 anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked...