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Karyopharm Announces FDA Approval of XPOVIO® (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy
-- Oral XPOVIO Now Available as a Treatment Option for Patients with Multiple Myeloma As Early as First Relapse; Significantly Expands Addressable Patient
About this update from Karyopharm Therapeutics Inc.
[{"type":"text","content":"-- Oral XPOVIO Now Available as a Treatment Option for Patients with Multiple Myeloma As Early as First Relapse; Significantly Expands Addressable Patient Population --\n -- Oral XPOVIO is Now the Only Multiple Myeloma Drug Indicated as Part of an Approved, Once-Weekly Velcade® (bortezomib) Combination Regimen --\n -- First Multiple Myeloma Drug with a New Mechanism of Action Approved by the FDA in the Second-Line Setting Since 2016 -\n -- FDA Approval Comes Approximately Three Months Ahead of Target PDUFA Date --\n -- Karyopharm to Hold an Investor Conference Call and Webcast Today at 1:00 p.m. ET --\n\n\nNEWTON, Mass., Dec. 18, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved XPOVIO® (selinexor), the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. XPOVIO was previously approved under the FDA's Accelerated Approval Program for the treatment of adult patients with relapsed or refractory multiple myeloma 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.\n\"Today's U.S. approval broadens the existing label for XPOVIO and allows Karyopharm to offer a new, highly active, treatment option to a significantly expanded patient population,\" said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. \"We believe the expanded reach of XPOVIO will address a critical need for patients with multiple myeloma given its novel mechanism of action, convenient oral administration and established rapid and sustained efficacy profile. The XPOVIO label expansion approval was supported by the pivotal Phase 3 BOSTON study, which was recently published in The Lancet. This approval was made possible by the patients, caregivers and physicians who participated in the clinical development of XPOVIO, as well as our global, dedicated Karyopharm team that has worked tirelessly to advance this innovative therapy to the greater m...