Elzonris (tagraxofusp-erzs) for blastic plasmacytoid dendritic cell neoplasm (BPDCN)

FDA approves Elzonris for blastic plasmacytoid dendritic cell neoplasm
https://www.mdedge.com/hematologynews/article/191723/rare-diseases/fda-approves-elzonris-blastic-plasmacytoid-dendritic
Laura Nikolaides, Hematology News

Dec 21st, 2018 - The Food and Drug Administration has approved tagraxofusp-erzs (Elzonris) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients, 2 years of age and older. Approval was based on efficacy in two cohorts of patients in a single-arm clinical trial.

Drug under priority review for BPDCN
https://www.mdedge.com/content/drug-under-priority-review-bpdcn
HT Staff

Aug 15th, 2018 - Photo by Bill Branson Vials of drug The US Food and Drug Administration(FDA) has accepted for priority review the biologics license application seeking approval for tagraxofusp (Elzonris, SL-401) to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN). The FDA expects to make a decision on this application by February 21, 2019.

FDA OKs New Options for Two Rare Blood Diseases
https://www.medpagetoday.com/hematologyoncology/hematology/77084

Dec 21st, 2018 - WASHINGTON -- The FDA announced new approvals for two rare and life-threatening blood diseases on Friday, as blastic plasmacytoid dendritic cell neoplasm (BPDCN) gets its first approved agent and paroxysmal nocturnal hemoglobinuria (PNH) gets a new drug that drastically cuts the frequency of treatments. BPDCN Gets First Approved Drug The FDA approved the infusion therapy tagraxofusp (Elzonri...