FDA has granted Fast Track designation to selinexor, Karyopharm Therapeutics Inc.’s first in class, oral SINE compound, for the treatment of patients with diffuse large B-cell lymphoma who have received at least two prior therapies and are not eligible for high dose chemotherapy with stem cell rescue or CAR-T therapy.
The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, with a two-day, back-to-back marathon meeting, signaling a return to business at FDA after significant upheaval at the agency.
