Pharmamarketeer

FDA approves multiple myeloma therapy Xpovio despite safety concerns

The FDA has made the controversial decision to approve the nuclear export inhibitor Xpovio (selinexor) from Karyopharm Therapeutics, in combination with dexamethasone, in the treatment of a sub-population of relapsed or refractory multiple myeloma (RRMM) patients, despite an advisory panel recommending against approval earlier this year.

The US agency chose to approve the drug under its accelerated pathway for adult RRMM patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory

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