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FDA Approves Elzonris

FDA Approves Elzonris2018.12.24

NEW YORK, December 21, 2018 (GLOBE NEWSWIRE) – Stemline Therapeutics, Inc. (NASDAQ:STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted approval of Elzonris (tagraxofusp-erzs; SL-401) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients two years and older, in both treatment-naïve and previously-treated populations. Elzonris is the first treatment approved for BPDCN and the first approved CD123-targeted therapy.

BPDCN is an aggressive, orphan hematologic malignancy with historically poor outcomes and is an area of unmet medical need. BPDCN may present with features similar to, and can be mistaken for, certain diseases including acute myeloid leukemia, non-Hodgkin’s lymphoma, acute lymphocytic leukemia, myelodysplastic syndromes, and chronic myelomonocytic leukemia, as well as other malignancies with skin manifestations. BPDCN typically presents in the bone marrow and/or skin, and may also involve lymph nodes and viscera. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56.

“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.”

CD123 is a key marker in identifying BPDCN and is a rapidly emerging target for therapeutic research in a variety of cancers. Elzonris is designed to specifically target CD123, and, within a triad of signature markers, enables proper diagnosis.

“Tagraxofusp represents an unprecedented leap forward in the treatment of BPDCN, an aggressive malignancy with no approved therapeutic options until now,” said Andrew Lane, M.D., Ph.D., Assistant Professor at Harvard Medical School and Dana-Farber Cancer Institute and a principal investigator on the tagraxofusp clinical trial. “I have witnessed firsthand the significant responses a number of my patients experienced with tagraxofusp and a proportion of responders were able to receive a stem-cell transplant following remission.”

Elzonris was granted Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD), and the Elzonris Biologics License Application (BLA) 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 (EMA) granted accelerated assessment to the upcoming Elzonris Marketing Authorization Application (MAA) submission, which is expected in the first quarter of 2019.


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