The US Food and Drug Administration (FDA) has placed a partial hold on all clinical trials involving selinexor according to Karyopharm Therapeutics, the company developing the drug. Selinexor is the first in a new class of drugs known as Selective Inhibitor of Nuclear Export (SINEā„¢) compounds which by inhibiting XPO-1 mediated nuclear-cytoplasmic protein transport, causes the retention of tumour suppressor proteins in the nucleus and induction of cell apoptosis. The partial hold is due to incomplete information in the investigator’s brochure regarding serious adverse events associated with the drug and has meant that several myeloma trials, including the Phase IIb STORM trial for relapsed and/or refractory myeloma patients, have halted additional recruitment, although patients already taking selinexor may remain on treatment. Karyopharm has submitted amendments and a decision by the FDA is expected in due course.

 

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