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Xpovio FDA 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; Diffuse Large B-cell Lymphoma

Xpovio (selinexor) is a first in class Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist for the treatment of patients adult patients with multiple myeloma (RRMM) and relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Indications

  • Multiple Myeloma
    • in combination with dexamethasone 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.
  • Diffuse Large B-Cell Lymphoma
    • for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.

These indications are approved under accelerated approval based on response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Development Timeline for Xpovio

DateArticle
Jun 22, 2020Approval Karyopharm Announces FDA Approval of Xpovio (selinexor) for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
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

Further information

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