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Biopharmaceutical company ImmunoGen recently announced that its antibody-drug compound (ADCs) IMGN632 has been awarded a "breakthrough therapy title" by the U.S. Food and Drug Administration (FDA) for the treatment of recurring or recurring recurring reoccurring reoccurring cystic plasma cell-like dendrites (BPDCN).
cystic plasma cell-like dendrites (BPDCN) is an invasive blood system cancer caused by the overexposed lebinocyte-mediate-3 sub-unit α (CD123) of converted plasma cell-like dendrites. Mark Enyedy, President and CEO of immunoGen,
ImmunoGen, said, "We are pleased that the FDA has awarded the ADC-IMGN632 breakthrough therapy title for CD123, highlighting the urgent medical needs of patients with this rare and invasive cancer."
according to FDA guidelines, the Breakthrough Therapy Title is designed to accelerate drug development and review for the treatment of serious diseases and has produced preliminary clinical evidence that the drug may be substantially better than existing therapies.
based on imGN632's first human study, IMGN632 was awarded the "Breakthrough Therapy Title," the initial data from the study were presented in oral reports from the 2019 annual meeting of the American Society of Hematology (ASH).
latest data from the IMGN632 single-drug treatment BPDCN dose extension queue will be published in the December issue of ASH.
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