The Food and Drug Administration granted accelerated approval of selinexor, a nuclear transport inhibitor (marketed as XPOVIO by Karyopharm Therapeutics), for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
Indications: Selinexor is intended for adult patients with relapsed/refractory DLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.
Dosage/Administration: The recommended dosage is 60 mg taken orally on Days 1 and 3 of each week for DLBCL.
Adverse reactions: The most common adverse reactions in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3-4 laboratory abnormalities are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia.
“Selinexor is an oral drug with a novel mechanism of inhibiting the transport of key molecules including tumor suppressor proteins and oncogenic mRNAs from the nucleus of a cell. Based on the results of the SADAL study in which 134 patients with diffuse large B-cell lymphoma (DLBCL) had an overall response rate of 29%, selinexor was FDA approved for patients with DLBCL who are relapsed or refractory to at least 2 prior therapies. This patient population has limited treatment options and may have relapsed after or not be candidates for cellular therapies including autologous stem cell transplant or chimeric antigen receptor T-cells. Side effects of selinexor including GI toxicities and cytopenias can be managed with supportive care and close monitoring.”
Sarah Rutherford, MD
Assistant Professor of Medicine, Weill Cornell Medicine
Disclosure: Dr. Rutherford receives research funding from and serves as a consultant to Karyopharm.
U.S. Food and Drug Administration. 2020. Approval announcement.