The FDA awarded Gilead CD47 a single anti-breakthrough drug

. 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 bone marrow growth abnormality syndrome (MDS).MDS is a cancer caused by blood cells that form in the bone marrow that are dysfunctional or dysfunctional. In the United States, about 15,000 people are diagnosed with MSS each year, and no new treatments have been approved in 14 years. Low-risk MDS patients have an average survival of 6 years and high-risk MDS patients have an average survival period 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 being swallowed by macrophages using the "Don't Eat Me" signal.
magrolimab has been developed in a number of hematological and solid tumor malignancies, including MDS. Previously, 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). Magrolimab has also been granted MDS and AML orphan drug eligibility (ODD) by the FDA 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 can be developed with closer guidance, including from senior FDA officials, to ensure that new treatment options are available to patients in the shortest possible time.Based on the positive results of the ongoing Phase 1b study, the FDA has granted magrolimab a breakthrough drug for MDS. The study evaluated the combined treatment of patients with previously untreated medium, high, and extremely high-risk MDS with magrolimab and aza cytosine. Data presented at the 2020 Meeting of the European Society of Hematology (EHS) show 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 joint treatment of magolimab and azatsin . Magrolimab is well-to-do with aza cytosine therapy. The maximum to-to-do dose was not reached, and no MDS patients stopped treatment due to adverse events associated with treatment.Currently, magrolimab is conducting a double-blind, placebo-controlled, randomized Phase 3 ENHANCE trial for previously untreated, high-risk MDS patients. The test will evaluate the safety and ability of magrolimab combined azatsine through CR and CR duration. (Bio Valley Bioon.com)original origin: Gilead's Magrolimab, an Investigational Anti-CD47 Monoclonal Antibody, Receives FDA File Therapy Designation for Myelodysplastic