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Xpovio Approval History

FDA Approved: Yes (First approved July 3, 2019)
Brand name: Xpovio
Generic name: selinexor
Dosage form: Tablets
Company: Karyopharm Therapeutics Inc.
Treatment for: Multiple Myeloma

Xpovio (selinexor) is a first in class Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist for the treatment of patients adult patients with relapsed or refractory multiple myeloma (RRMM).

  • Xpovio was granted accelerated approval for use in combination with dexamethasone for the treatment of adult patients with 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.
  • Common adverse reactions include thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection.

Development History and FDA Approval Process for Xpovio

DateArticle
Jul  3, 2019Approval FDA Approves Xpovio (selinexor) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Mar 14, 2019Karyopharm Announces FDA Extension of Review Period for Selinexor New Drug Application
Feb 27, 2019Karyopharm Announces Outcome of FDA Advisory Committee Meeting Reviewing Selinexor for the Treatment of Patients with Triple Class Refractory Multiple Myeloma
Dec  1, 2018Karyopharm Reports Positive Top-Line Phase 2b SADAL Data for Selinexor in Patients with Diffuse Large B-Cell Lymphoma at the American Society of Hematology 2018 Annual Meeting
Nov  7, 2018Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma
Oct  5, 2018U.S. FDA Accepts Karyopharm’s New Drug Application for Selinexor and Grants Priority Review
Sep 13, 2018Phase 2b STORM Data Evaluating Selinexor in Patients with Penta-Refractory Multiple Myeloma Presented at the Society of Hematologic Oncology 2018 Annual Meeting
Aug 28, 2018Karyopharm to Present Phase 2b STORM Data Evaluating Selinexor in Patients with Penta-Refractory Multiple Myeloma at the Society of Hematologic Oncology 2018 Annual Meeting
Jul 18, 2018Karyopharm Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma
Apr 30, 2018Karyopharm Announces Positive Top-Line Data from Phase 2b STORM Study Evaluating Selinexor in Patients with Penta-Refractory Multiple Myeloma
Apr 10, 2018Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Penta-Refractory Multiple Myeloma
Jan 14, 2016Karyopharm Initiates Clinical Trial of Oral Selinexor in Advanced Liposarcoma
Oct 19, 2015Karyopharm Initiates STOMP Clinical Trial of Oral Selinexor in Multiple Myeloma
May 30, 2015Karyopharm Presents Clinical Data for Selinexor (KPT-330) in Patients With Heavily Pretreated Gynecological Cancers
Dec 11, 2014Karyopharm Initiates Third Registration-Directed Clinical Trial of Oral Selinexor (KPT-330)

Further information

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