Food and Drug Administration (FDA) accepted our first Investigational New Drug (IND) application to initiate a multi-center Phase 1/2 clinical trial of MB-102 (CD123 CAR T) in acute myeloid leukemia (AML),
blastic plasmacytoid dendritic cell neoplasm (BPDCN) and high-risk myelodysplastic syndrome (MDS).'
Stemline Therapeutics announced that the Centers for Medicare & Medicaid Services granted approval for a new technology add-on payment for ELZONRIS for the treatment of adult and pediatric patients, two years and older, with
blastic plasmacytoid dendritic cell neoplasm.
Bone marrow aspiration revealed an 80-90%
blastic infiltration with suppressed erythropoiesis and megakaryopoiesis.
Elzonris (tagraxofusp-erzs), which has a MW of 57,695, is a cytotoxin indicated for the treatment of
blastic plasmacytoid dendritic cell neoplasm.
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare myeloid malignancy accounting for less than 1% of all acute leukemias.
Proliferative index (Ki-67) was about 20-30% without overt
blastic change seen [Figure 3].
One previous study (17) demonstrated that CD47 is upregulated in AML and
blastic phase CML, but not in other myeloproliferative disorders, including PV, post-PV MF, ET, and PMF (n=5).
Mustang Bio was granted orphan drug designation for MB-102 (CD123 CAR T) for the treatment of
blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and incurable blood cancer with a median survival of less than 18 months and no standard of care.
M2 PHARMA-December 28, 2018-FDA Approves Elzonris (tagraxofusp), the First Treatment for
Blastic Plasmacytoid Dendritic Cell Neoplasm and First CD123-Targeted Therapy
It was reported on Friday that the United States Food and Drug Administration (USFDA) has granted approval for US-based Stemline Therapeutics, Incorporated's (NASDAQ: STML) ELZONRIS product aimed at treating
blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Blastic plasmacytoid dendritic cell neoplasm is a rare myeloid neoplasm of immature plasmacytoid dendritic cells.