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FDA grants fast track designation to selinexor for relapsed or refractory diffuse large B-cell lymphoma
The FDA granted fast track designation to selinexor for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.
The designation applies to use of the agent for patients who received at least two prior therapies and are not eligible for high-dose chemotherapy with stem cell rescue or chimeric antigen receptor T-cell therapy.
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 ongoing phase 2b SADAL study is designed to evaluate selinexor for patients with relapsed or refractory DLBCL who received two to five prior therapies and are not eligible for hematopoietic stem cell transplantation.
The multicenter, open-label trial is designed to enroll 125 patients who will receive 60 mg oral selinexor twice weekly in 4-week cycles. Objective response rate is the primary endpoint, and duration of response is a key secondary endpoint.
“The receipt of fast track designation from the FDA for selinexor in relapsed DLBCL underscores the great unmet medical need for this aggressive form of lymphoma,” Sharon Shacham, PhD, MBA, founder, president and chief scientific officer of Karyopharm, said in a company-issued press release.
The FDA previously granted priority review and fast track designation to selinexor for the treatment of patients with penta-refractory multiple myeloma. A decision on that indication is expected by April 6.