Immunex Corp. has filed with the FDA a new supplemental productlicense application (PLA) for Leukine (sargramostim), a white bloodcell stimulant. Leukine has already been approved for use to stimulatewhite blood cell activity following an autologous bone marrowtransplant, and as a treatment for cancer patients whose bone marrowtransplants have failed.If approved, the new application would allow use of leukine toaccelerate white cell recovery following chemotherapy for patientswith acute non-lymphoblastic leukemia. In addition, Immunex(NASDAQ:IMNX) of Seattle last year filed a PLA for the use ofLeukine to accelerate white cell recovery following chemotherapy for abroad range of malignancies. That application is still pending.Immunex has requested a priority review for its latest PLA under theFDA's new guidelines to speed approval of products to treat life-threatening conditions. If granted, the FDA should make adetermination within six months, instead of the usual 12. - PhilippaMaister
(c) 1997 American Health Consultants. All rights reserved.