Selinexor Approval Status
FDA Approved: No (Pending Approval)
Generic name: selinexor
Company: Karyopharm Therapeutics Inc.
Treatment for: Multiple Myeloma
Selinexor (KPT-330) is a first in class Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist in development for the treatment of patients with penta-refractory multiple myeloma.
Development Status and FDA Approval Process for selinexor
|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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