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FDA division lifts partial hold on Karyopharm cancer drug trials

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FDA division lifts partial hold on Karyopharm cancer drug trials

The U.S. FDA's Division of Hematology Products lifted a partial clinical hold on the trials of Karyopharm Therapeutics Inc.'s blood cancer drug Selinexor.

The clinical hold was not the result of a patient death or a change in the safety profile but due to incomplete information being submitted to the FDA, the company said earlier this month.

Enrollment can now resume in all Selinexor studies in hematologic malignancies. This includes a refractory multiple myeloma study, a lymphoma study, and a study of Selinexor and backbone therapies in multiple myeloma.

A phase 2 Selinexor study previously failed to meet its primary endpoint.

Michael Kauffman, CEO of Karyopharm, said he expects the FDA's solid-tumor divisions to similarly remove their partial clinical holds and that previously disclosed enrollment rates and timelines for ongoing and planned trials should not be materially affected.