FDA has accepted Karyopharm Therapeutics Inc.’s supplemental New Drug Application seeking approval for Xpovio—its first-in-class, oral selective inhibitor of nuclear export compound, as a new treatment for patients with multiple myeloma after at least one prior line of therapy.
In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.
