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The Lymphoma & CLL Hub is an independent medical education platform, sponsored by Beigene and Roche, and supported through educational grants from Bristol Myers Squibb, Ipsen Biopharmaceuticals, Pfizer, and Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC. View funders.

2017-04-06T11:17:45.000Z

The FDA lifts hold on clinical trials of selinexor in Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia

Apr 6, 2017
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Last month, the Lymphoma Hub reported on a hold, put in place by the U.S. Food and Drug Administration (FDA), on clinical trials of the experimental drug selinexor (KPT-330) in CLL and DLBCL.

On 30th March 2017, the FDA’s Division of Hematology Products lifted the clinical hold. Enrollment and dosing of new patients is set to resume in all trials of selinexor in hematological malignancies.

Such studies include the SADAL trial in R/R DLBCL and a phase I trial combining selinexor plus ibrutinib for aggressive MCL, DLBCL, and R/R CLL/SLL.

  1. Seeking Alpha. FDA lifts partial clinical hold on clinical studies of Karyopharm's selinexor. 2017 Mar 30. https://seekingalpha.com/news/3254399-fda-lifts-partial-clinical-hold-clinical-studies-karyopharms-selinexor. [Accessed 2017 Apr 06].

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