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.
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