FDA Tells Karyopharm to Conduct Another Trial on Endometrial Cancer Drug Xpovio
The FDA has told Karyopharm Therapeutics that before the agency will grant market approval for Xpovio (selinexor) for front-line maintenance of advanced or recurrent endometrial cancer, the company would need to run a new trial looking at patients with the p53 wild-type form of the cancer.
That was the population for which Xpovio produced the best data in a recent study. For that trial, Karyopharm announced mildly positive overall results but great outcomes for the subgroup with 13.7 months progression-free survival compared with 3.7 months in the control group.
Karyopharm said it has had a productive meeting with the FDA and is ready to work with the agency to design a new trial scrutinizing Xpovio’s effect on the p53 wild-type population.
Xpovio was granted accelerated approval in 2019 in combination with the corticosteroid dexamethasone for the treatment of adults with relapsed refractory multiple myeloma.
About Selixinor
Selinexor sold under the brand name Xpovio among others, is a selective inhibitor of nuclear export used as an anti-cancer medication. It works by blocking the action of exportin 1 and thus blocking the transport of several proteins involved in cancer-cell growth from the cell nucleus to the cytoplasm, which ultimately arrests the cell cycle and leads to apoptosis. It is the first drug with this mechanism of action.
About Karyophsrm
Karyopharm is an innovation-driven pharmaceutical company whose core technology leverages the inhibition of nuclear export as a mechanism to treat patients with cancer and other medical conditions. Since its founding in 2008, Karyopharm has been an industry leader in oral Selective Inhibitor of Nuclear Export (SINE) technology, developed to address a fundamental mechanism of oncogenesis: Nuclear Export Dysregulation.
March 3, 2022
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