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