Karyopharm Therapeutics gets FDA extension of selinexor NDA review period
Karyopharm Therapeutics (NASDAQ:KPTI) announced that the FDA has extended its review of the company’s NDA for selinexor by three months.
Selinexor’s NDA is currently under priority review for its use in combination with dexamethasone for the treatment of patients with relapsed refractory multiple myeloma. Selinexor is a first-in-class, oral selective inhibitor of nuclear export compound that causes the accumulation of tumor suppressor proteins in the cell nucleus, inducing apoptosis in cancer cells.
Following its February 2019 meeting with the FDA, Karyopharm submitted additional, existing clinical information as an amendment to the NDA, which enabled extension of the PDUFA action date to July 6, 2019