FDA granted a Fast Track Designation for a new drug in Multiple Myeloma
Selinexor (KPT-330) was recently granted a Fast Track
designation by the FDA for the treatment of patients with multiple myeloma who
have received at least 3 prior lines of therapy, according to Karyopharm
Therapeutics, the manufacturer of the oral SINE (selective inhibitor of nuclear
export) compound.
Selinexor links to and inhibits XPO1, a nuclear export protein, which leads to the accumulation of tumor suppressor proteins in the nucleus of the cell. This reinitiates and amplifies their tumor suppressor function, which investigators believe leads to the selective induction of apoptosis in cancer cells, while sparing normal cells.
The designation is based on data from the phase IIb STORM study, a single-arm, open-label, multicenter study of selinexor plus dexamethasone in patients with penta-refractory multiple myeloma.
Selinexor links to and inhibits XPO1, a nuclear export protein, which leads to the accumulation of tumor suppressor proteins in the nucleus of the cell. This reinitiates and amplifies their tumor suppressor function, which investigators believe leads to the selective induction of apoptosis in cancer cells, while sparing normal cells.
The designation is based on data from the phase IIb STORM study, a single-arm, open-label, multicenter study of selinexor plus dexamethasone in patients with penta-refractory multiple myeloma.
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