FDA unlikely to support supplemental New Drug Application approval for selinexor for advanced or recurrent endometrial cancer
Following submission of phase III data from SIENDO study on this first-in-class, oral selective inhibitor of nuclear export, showing 50% improvement in median progression-free survival vs. placebo, the FDA had was not convinced of overall clinical benefit.
Source:
Biospace Inc.
SPS commentary:
The company said the drug would undergo further studies in patients with advanced or recurrent endometrial cancer who also had the p53 wild-type genome, as they had experienced more benefit in the trial (progression-free survival rate of 13.7 months vs. average of 5.7 months for other patients treated with selinexor and 3.8 months for patients on placebo).
In June 2021, the MHRA granted conditional marketing authorization in UK for selinexor (Nexpovio) in combination with dexamethasone for treatment of adult patients with relapsed and or refractory multiple myeloma