The FDA designates Gilead Sciences’ (NASDAQ:GILD) magrolimab a Breakthrough Therapy for the treatment of newly diagnosed myelodysplastic syndromes, a group of cancers in which immature blood cells in the bone marrow do not mature. It also has Fast Track status for the indication.
Magrolimab, acquired in its $4.9B takeover of Forty Seven in April, is a humanized IgG4 monoclonal antibody that binds to a certain CD47 receptor on immune cells called macrophages. Blocking the receptor eliminates the way cancer cells avoid being killed by these cells.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
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