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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View References
    FDA approves tagraxofusp-erzs for blastic plasmacytoid dendritic cell neoplasm. US Food & Drug Administration. Available at https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm629090.htm?utm_campaign=12-21-2018%20FDA%20approves%20tagraxofusp-erzs%20for%20BPDCN&utm_medium=email&utm_source=E. Accessed 1/4/19.
  1. FDA Approves Elzonris to Treat Rare Blood Cancer. Cure Today. Available at https://www.curetoday.com/articles/fda-approves-elzonris-to-treat-rare-blood-cancer. Accessed 1/4/19.
  2. FDA expands Sprycel approval to include certain children with acute lymphoblastic leukemia. Healio. Available at https://www.healio.com/hematology-oncology/leukemia/news/online/%7Bd076ee13-cf60-4cb3-9968-78d2cbf0a76f%7D/fda-expands-sprycel-approval-to-include-certain-children-with-acute-lymphoblastic-leukemia. Accessed 1/4/19.
  3. American Cancer Society. Acute Lymphoblastic Leukemia. Available at https://www.cancer.org/. Accessed 9/12/17.