Stemline says Elzonris approval ‘major step forward’ for people with BPDCN

Stemline Therapeutics, Inc. announced that the U.S. Food and Drug Administration has granted approval of ELZONRIS for the treatment of blastic plasmacytoid dendritic cell neoplasm in adult and pediatric patients two years and older, in both treatment-naive and previously-treated populations. ELZONRIS is the first treatment approved for BPDCN and the first approved CD123-targeted therapy. “Today’s approval of tagraxofusp is a major step forward for people with BPDCN, their families and the medical community,” said Naveen Pemmaraju, M.D., 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.” ELZONRIS was granted Breakthrough Therapy Designation and Orphan Drug Designation, and the ELZONRIS Biologics License Application was evaluated under Priority Review by the FDA. “We are incredibly thankful to the patients, their families and physicians who participated in our clinical trials, and proud of our exceptional team here at Stemline, all of whom played critical roles in bringing this breakthrough treatment to fruition,” said Ivan Bergstein, M.D., chief executive officer of Stemline Therapeutics. “Stemline is proud to provide the first approved treatment for BPDCN, and we are committed to making ELZONRIS available to patients.” Stemline intends to bring ELZONRIS to patients with BPDCN globally. In November 2018, the European Medicines Agency granted accelerated assessment to the upcoming ELZONRIS Marketing Authorization Application submission, which is expected in the first quarter of 2019. ELZONRIS is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm in adults and in pediatric patients 2 years and older. The ELZONRIS label contains a boxed warning for CLS, which may be life-threatening or fatal and can occur in patients receiving ELZONRIS. Physicians are advised to monitor for signs and symptoms of CLS and take actions as recommended in the full prescribing information.

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