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FDA places partial clinical hold on trials evaluating selinexor
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The FDA placed a partial clinical hold on all clinical trials designed to evaluate selinexor, according to the drug’s manufacturer.
Selinexor (KPT-330, Karyopharm Therapeutics) is a first-in-class, oral selective inhibitor of nuclear export compound. The drug binds with and inhibits the nuclear export protein XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus. The goal of treatment is selective induction of apoptosis in cancer cells, while sparing healthy cells.
The FDA indicated the hold was due to incomplete information in the existing version of the investigator's brochure, including an incomplete list of serious adverse events associated with the drug, according to a company-issued press release.
Karyopharm noted the partial clinical hold was not a result of any patient death or new information regarding the safety profile of selinexor.
As of March 10, Karyopharm has amended the investigator's brochure, updated the informed consent documents accordingly and has submitted such documents to the FDA as requested.
The FDA has 30 days from receipt of Karyopharm's submission to notify the company whether the partial clinical hold is lifted. During that time no new patients may be enrolled, but all current patients with stable disease or better may remain on selinexor therapy.
Over 1,900 patients have been treated with the combination use of selinexor plus low-dose dexamethasone (STORM trial) and backbone therapies (STOMP trial) for the treatment of multiple myeloma, diffuse large B-cell lymphoma (SADAL trial) and liposarcoma (SEAL trial).
In addition, the pivotal, randomized phase 3 BOSTON trial of selinexor in combination with bortezomib (Velcade, Takeda Oncology) and low-dose dexamethasone in patients with multiple myeloma is intended to start this year.