Pharmaceutical

Karyopharm Therapeutics (NASDAQ:KPTI) has announced that it has initiated a rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for approval of selinexor, its novel, oral SINE compound to treat patients with penta-refractory multiple myeloma. As quoted in the press release: Patients with penta-refractory myeloma have previously received …

Karyopharm Therapeutics (NASDAQ:KPTI) has announced that it has initiated a rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for approval of selinexor, its novel, oral SINE compound to treat patients with penta-refractory multiple myeloma.

As quoted in the press release:

Patients with penta-refractory myeloma have previously received the two proteasome inhibitors (PIs), Velcade® (bortezomib) and Kyprolis® (carfilzomib), the two immunomodulatory drugs (IMiDs), Revlimid® (lenalidomide) and Pomalyst® (pomalidomide), and the anti-CD38 monoclonal antibody Darzalex® (daratumumab), and their disease is refractory to at least one PI, at least one IMiD, Darzalex and their most recent therapy. The Company expects to complete the NDA submission during the second half of 2018. Selinexor has received both Orphan Drug and Fast Track designations from the FDA for this indication.

“We believe that selinexor has the potential to address the critical unmet need for patients with highly resistant, penta-refractory myeloma, where the disease is no longer responsive to standard approved therapies,” said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. “The commencement of this rolling submission for the oral selinexor NDA marks the first-ever application for regulatory approval of an Exportin 1 (XPO1) inhibitor and represents a major milestone for the Company. We are proud of the positive Phase 2b STORM study results underlying this application and we will work expeditiously to complete the submission this year.”

Pending marketing approval by the FDA, Karyopharm plans to commercialize selinexor in the U.S. The Company also plans to submit a Marketing Authorization Application to the European Medicines Agency in early 2019 with a request for conditional approval.

Click here to read the full press release.

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