Total mitigation rate of 92%! FDA grants Gilead CD47 single anti-magrolimab breakthrough drug: Treatment of bone marrow growth syndrome!

September 16, 2020 // -- Gilead Sciences recently announced that the U.S. Food and Drug Administration (FDA) has granted magolimab Breakthrough Drug Qualification (BTD), the first anti-CD47 monoclonal antibody to treat newly diagnosed myeloid growth syndrome (MDS).
MDS is a cancer caused by blood cells that form in the bone marrow that are dysfunctional or dysfunctional.
, about 15,000 people are diagnosed with MDS each year, and no new treatments have been approved in 14 years.
low-risk MDS patients had an average survival of 6 years, and high-risk MDS patients had an average survival of about 18 months.
magolimab is a monoclonal antibody that blocked the CD47 signal after Gilead bought Forty Seven for about $4.9 billion in April.
magrolimab is designed to interfere with the recognition of CD47 by SIRP alpha subjects on macrophages, thereby blocking cancer cells from using the "don't eat me" signal to avoid being swallowed by macrophages.
magrolimab has been developed in a number of hematological and solid tumor malignancies, including MDS.
, magrolimab was awarded fast-track eligibility (FTD) by the FDA for MDS, acute myeloid leukemia (AML), diffuse large B-cell lymphoma (DLBCL) and fable lymphoma (FL).
magolimab was also granted ODD status by the FDA for the treatment of MDS and AML orphan drugs, and by the European Medicines Agency (EMA) for the treatment of AML orphan drugs.
BTD is a new drug review channel created by the FDA in 2012 to accelerate the development and review of new drugs used to treat serious or life-threatening diseases, and there is preliminary clinical evidence that the drug has significantly improved one or more clinically significant endpoints compared to existing drugs.
access to BTD drugs, and closer guidance, including from senior FDA officials, in the development process to ensure that new treatment options are available to patients in the shortest possible time.
fda has granted magolimab a breakthrough drug for MDS based on positive results from ongoing Phase 1b studies.
the study evaluated the combined treatment of previously untreated medium, high, and very high-risk MDS patients with magolimab and aza cytosine.
, presented at the 2020 Meeting of the European Society of Hematology (EHS), showed that the objective remission rate (ORR) was as high as 91% and the total remission rate (CR) was as high as 42% among the assessable patients who received a combined treatment of magolimab and azab.
good tolerance to magrolimab combined with azatsin therapy.
did not reach the maximum toned dose, and no MDS patients stopped treatment for adverse events.
, magrolimab is currently undergoing a double-blind, placebo-controlled, randomized Phase 3 ENHANCE trial for previously untreated high-risk MDS patients.
the test will evaluate the safety and effectiveness of magolimab combined azasides through CR and CR duration.
() Original origin: Gilead's Magrolimab, an InvestigationAl Anti-CD47 Monoclonal Antibody, Receives FDA File Therapy Designation for Treatment of Myelodysplastic Syndrome.