FDA Grants Priority Review to Selinexor for Penta-Refractory Multiple Myeloma

Monday, October 08, 2018
The Food and Drug Administration (FDA) has granted a priority review to the XPO1 inhibitor selinexor for the treatment of patients with penta-refractory multiple myeloma.

In its announcement, Karyopharm Therapeutics, manufacturer of the therapy, cited results from the phase IIb STORM trial as the basis for its new drug application (NDA). The trial examined the combination of selinexor and dexamethasone in patients with penta-refractory multiple myeloma. Updated data from the study presented at the 2018 Society of Hematologic Oncology (SOHO) Annual Meeting showed that the doublet regimen was associated with an overall response rate (ORR) of 26.2% and a median overall survival (OS) of 8.6 months in patients with penta-refractory disease.1

Sundar Jagannath, MD, director of the Multiple Myeloma Program and professor of medicine at The Tisch Cancer Institute, Mount Sinai Health System, delivered the STORM findings at SOHO. He explained that patients who had a response to treatment, even a minor response, did significantly better, with a median OS of 15.6 months. Historically, the median OS in this patient population is an estimated 3.6 months.

According to Karyopharm, the study defined

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