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Elzonris Approved for BPDCN and Sprycel Approval Expanded

Elzonris approved for BPDCN

The FDA has approved ElzonrisTM (tagraxofusp-erzs), a targeted therapy, for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and children over age 2. This is the first treatment approved for BPDCN and is a CD123-directed cytotoxin. BPDCN is a rare hematologic cancer that often progresses into acute leukemia.1,2

Prior to this approval, most individuals with BPDCN received the standard of care regimen of chemotherapy followed by a stem cell transplant. BPCDN predominantly impacts older patients who may not be able to tolerate such an intensive treatment regimen.2 Elzonris represents a new option for people with BPDCN.

Sprycel pediatric indication expanded

The FDA recently expanded its approval for the targeted therapy Sprycel® (dasatinib) in combination with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in children over 1 year.3 ALL is a common childhood cancer and is more common in children than adults, with the greatest risk in children aged 5 and younger.4

Sprycel had previously been approved for several indications, including newly diagnosed and chronic, accelerated, myeloid or lymphoid Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adults, refractive Ph+ ALL in adults, and refractive Ph+ CML in pediatric patients.3

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    FDA approves tagraxofusp-erzs for blastic plasmacytoid dendritic cell neoplasm. US Food & Drug Administration. Available at Accessed 1/4/19.
  1. FDA Approves Elzonris to Treat Rare Blood Cancer. Cure Today. Available at Accessed 1/4/19.
  2. FDA expands Sprycel approval to include certain children with acute lymphoblastic leukemia. Healio. Available at Accessed 1/4/19.
  3. American Cancer Society. Acute Lymphoblastic Leukemia. Available at Accessed 9/12/17.