Gilead's Magrolimab Gets FDA Breakthrough Therapy Designation in Myelodysplastic Syndrome
September 15 2020 - 08:54AM
Dow Jones News
By Colin Kellaher
Gilead Sciences Inc. on Tuesday said the U.S. Food and Drug
Administration granted breakthrough-therapy designation to
magrolimab for the treatment of newly diagnosed myelodysplastic
syndrome.
The Foster City, Calif., biopharmaceutical company said the
designation is based on positive results of an ongoing Phase 1b
study, in which 91% percent of evaluable patients treated with
magrolimab plus azacitidine achieved an objective response, with
42% achieving a complete remission.
The FDA's breakthrough-therapy designation aims to expedite the
development and review of a drug for serious conditions when
preliminary clinical evidence shows the drug may show substantial
improvement over available therapies.
Gilead said about 15,000 people in the U.S. each year are
diagnosed with myelodysplastic syndrome, a type of cancer caused by
poorly formed or dysfunctional blood cells in the bone marrow,
adding that no new treatments have been approved in 14 years.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 15, 2020 08:39 ET (12:39 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Feb 2024 to Mar 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Mar 2023 to Mar 2024