On July 3, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
As a condition of accelerated approval, further clinical trials may be required to verify and describe selinexor’s benefit. FDA granted this application fast track designation and orphan drug designation.
Read FDA announcement.
Posted 7/3/2019
Understanding both the benefits to be had from offering BsAb therapy to its community and the scope of this undertaking, Vanderbilt-Ingram Cancer Center took a novel approach with its APP-led BsAb step-up dosing clinic, which won the program a 2026 ACCC Innovator Award.
