The FDA's Fast Track program is an expedited drug development and review program for new drugs or biologics which show promise in treating serious or life-threatening conditions and address an unmet medical need. Galinpepimut-S, SELLAS' WT1 cancer vaccine, is a late clinical-stage immunotherapy being developed to target hematologic cancers and solid tumors, including MPM, AML, multiple myeloma, ovarian and other cancers.