FDA Accepts Supplemental New Drug Application for Selinexor in Myeloma
Posted: Tuesday, July 21, 2020
On July 20, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application for selinexor in the treatment of multiple myeloma in patients who received at least one line of prior therapy. Previous FDA approval for selinexor was for the treatment of patients with pentarefractory multiple myeloma and relapsed or refractory diffuse large B-cell lymphoma. Selinexor is a first-in-class, oral selective inhibitor of nuclear export compound.
Selinexor is the focus of several clinical trials across multiple tumor types, including in combination with approved therapies for myeloma, in liposarcoma, and in endometrial cancer. A decision regarding the application is expected from the FDA early in 2021.
The most common adverse reactions observed in 20% or more of patients with multiple myeloma included thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection. Fatal adverse reactions occurred in 9% of patients, and serious adverse reactions were reported in 58% of patients.
