Tagraxofusp is under clinical development by Stemline Therapeutics and currently in Phase II for Myelofibrosis. According to GlobalData, Phase II drugs for Myelofibrosis have a 40% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. 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, relapsed multiple myeloma and refractory multiple myeloma.

Stemline Therapeutics overview

Stemline Therapeutics (Stemline), a subsidiary of A. Menarini Industrie Farmaceutiche Riunite Srl, is a clinical stage biopharmaceutical company that develops therapeutics to treat cancer stem cells. The company pipeline products include TAGRAXOFUSP, ELACESTRANT, SL-701, MEN1611, MEN1611, MEN1309, FELEZONEXOR and SL-901. Stemline products treat blastic plasmacytoid dendritic cell neoplasm (BPDCN), chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), breast cancer, acute myeloid leukemia (AML), colorectal cancer (CRC) and solid tumors. It also carries out the development and commercialization of novel oncology therapeutics. The company has operations across Europe. 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.

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.