FDA Grants Priority Review to Selinexor for Pentarefractory Multiple Myeloma
Posted: Thursday, October 18, 2018
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to Karyopharm Therapeutics’ new drug application for selinexor, a first-in-class, oral selective inhibitor of the nuclear export protein XPO1, as a new treatment for patients with pentarefractory multiple myeloma.
The FDA based this designation on results from the multicenter, single-arm, phase IIb STORM study (ClinicalTrials.gov identifier NCT02336815), which is evaluating selinexor in combination with low-dose dexamethasone in 122 patients with pentarefractory multiple myeloma. Selinexor is also being evaluated in several other mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a randomized phase III study in combination with bortezomib and low-dose dexamethasone, as a potential backbone therapy in combination with approved therapies in diffuse large B-cell lymphoma, and an investigator-sponsored study in endometrial cancer.
