FDA Accepts New Drug Application, Grants Priority Review to Selinexor for Pentarefractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has accepted a new drug application seeking accelerated approval for selinexor, a first-in-class, oral selective inhibitor of nuclear export (SINE) compound, as a new treatment for patients with pentarefractory multiple myeloma. The FDA also granted Priority Review to the application and assigned an action date of April 6, 2019, under the Prescription Drug User Fee Act.
Selinexor has received both Orphan Drug and Fast Track designations from the FDA for the treatment for patients with pentarefractory multiple myeloma.
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In April and September 2018, positive top-line data were reported from the phase IIb STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with pentarefractory multiple myeloma. A Marketing Authorization Application to the European Medicines Agency is planned for submission in early 2019 with a request for conditional approval.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
