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FDA Approves Tagraxofusp for Rare Hematologic Cancer

Gina Columbus @ginacolumbusonc
Published: Friday, Dec 21, 2018

Richard Pazdur, MD

Richard Pazdur, MD
The FDA has approved tagraxofusp-erzs (SL-401; Elzonris) infusion for the treatment of adult and pediatric patients, aged ≥2 years, with blastic plasmacytoid dendritic cell neoplasm (BPDCN).1

"Today's approval of tagraxofusp is a major step forward for people with BPDCN, their families and the medical community," said Naveen Pemmaraju, MD, associate professor at The University of Texas MD Anderson Cancer Center, and a principal investigator on the tagraxofusp clinical trial. "CD123 is expressed in BPDCN and a number of other hematologic malignancies. The approval of tagraxofusp, a CD123-targeted therapy, represents a new standard of care for patients with BPDCN."

References

  1. FDA approves first treatment for rare blood disease. FDA. Published December 21, 2018. https://bit.ly/2V2VD92?rel=0" . Accessed December 21, 2018.
  2. Pemmaraju N, Lane AA, Sweet KL, et al. Results of pivotal phase 2 clinical trial of tagraxofusp (SL-401) in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In: Proceedings from the 2018 ASH Annual Meeting; December 1-4, 2018; San Diego, California. Abstract 765.

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