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.