FDA accepts Karyopharm's NDA for selinexor with priority review

The US Food and Drug Administration (FDA) has accepted for filing with priority review the New Drug Application (NDA) seeking accelerated approval for Karyopharm Therapeutics’ (Nasdaq: KPTI) selinexor, its first in class, oral SINE compound, as a new treatment for patients with penta-refractory multiple myeloma.

The FDA also granted Karyopharm’s request for priority review and assigned an action date of April 6, 2019 under the Prescription Drug User-Fee Act (PDUFA). In its acceptance letter, the FDA has stated that it is currently planning to hold an advisory committee meeting to discuss this application.

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