Tagraxofusp is under clinical development by Stemline Therapeutics and currently in Phase III for Chronic Myelomonocytic Leukemia (CMML). According to GlobalData, Phase III drugs for Chronic Myelomonocytic Leukemia (CMML) have a 57% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Tagraxofusp’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Tagraxofusp overview

Tagraxofusp (Elzonris) acts as an immunosuppresant. It is formulated as injectable solution and concentrate for solution for intravenous route of administration. Elzonris is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older with both treatment-naïve and previously-treated blastic plasmacytoid dendritic cell neoplasm.

Tagraxofusp (SL-401) is under development for the treatment of  blastic plasmacytoid dendritic cell neoplasm, hematologic malignancies including blastic plasmacytoid dendritic cell neoplasm (BPDCN), relapsed/refractory myelofobrosis (MF), acute myeloid leukemia (AML), relapsed/refractory chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome (MDS), multiple myeloma and other disorders include systemic mastocytosis (SM), advanced symptomatic primary eosinophilic disorder (PED), systemic sclerosis, and hypereosinophilic syndrome. The drug candidate is administered through intravenous route as infusion. It is a diphtheria toxin (DT)-IL3 fusion protein. It acts by targeting the IL-3R and is developed based on StemScreen technology. The drug candidate was under development for the treatment of T-cell acute lymphoblastic leukemia (T-ALL), mantle cell lymphoma, Hodgkin’s lymphoma.

Stemline Therapeutics overview

Stemline Therapeutics (Stemline) is a clinical stage biopharmaceutical company that develops therapeutics to treat cancer stem cells and tumor bulk. The company has developed discovery platform StemScreen to identify novel compounds that target and kill cancer stem cells. Its products pipeline comprises of SL-401, SL-701, SL-801, SL-501 and SL-101. Stemline’s SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on CSCs and tumor bulk of hematologic cancers. The company’s SL-701 is an immunotherapy designed to activate the immune system to attack tumors. Its SL-801 is a novel oral small molecule reversible inhibitor of Exportin-1. Stemline is headquartered in New York, the US.

For a complete picture of Tagraxofusp’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.