On March 30, 2017 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) Division of Hematology Products has lifted the partial clinical hold placed on the clinical trials for selinexor (KPT-330), enabling patient enrollment and dosing of new patients in the Company’s clinical trials of selinexor in hematological malignancies (Press release, Karyopharm, MAR 30, 2017, View Source [SID1234518346]). The partial clinical hold was not the result of any patient death or any change in the safety profile of selinexor. Enrollment may now resume in all selinexor studies in hematologic malignancies, including the STORM study in refractory multiple myeloma, the SADAL study in relapsed/refractory diffuse large B-cell lymphoma (DLBCL), and the STOMP study of selinexor and backbone therapies in multiple myeloma. In addition, Investigator Sponsored Trials in hematologic malignancies with selinexor may resume accruing patients. Schedule your 30 min Free 1stOncology Demo! Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm, stated, "The Karyopharm team worked diligently to update and submit the required documents to the FDA, which allowed the hematology divison to expeditiously remove the partial clinical hold. We anticipate that the solid tumor divisions will follow suit shortly. Patient enrollment is again underway in our hematologic oncology studies. Our previously disclosed enrollment rates and timelines for both ongoing and planned trials are not expected to be materially impacted."
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