{"version":1,"type":"rich","provider_name":"Libsyn","provider_url":"https:\/\/www.libsyn.com","height":90,"width":600,"title":"AMJ Podcast | Episode 10 | Navigating BPDCN: Bridging Clinical Heterogeneity and Treatment Evidence with Tagraxofusp","description":" This episode was funded by Stemline Therapeutics, Inc., a Menarini Company Group, and is intended for United States healthcare professionals only. The opinions expressed here are solely those of the named speaker and do not\u202frepresent\u202fthose of his affiliated institution. His participation in this discussion\u202fdoes not constitute, and should not be construed as, endorsement, recommendation, or promotion of any product, service, or organization. In this podcast, we shine a light on\u202fblastic\u202fplasmacytoid dendritic cell neoplasm (BPDCN), a rare and\u202fhighly aggressive\u202fhematologic malignancy. Before 2018, there were no approved treatments for BPDCN, and oncologists typically used chemotherapy regimens commonly used for acute\u202fleukemias\u202fand lymphomas that were associated with limited durability and high rates of induction mortality. The landscape changed when the FDA approved tagraxofusp,\u202fa CD123-directed fusion protein, as the first therapy approved for adult and pediatric patients 2 years and older with BPDCN. Listen to Thomas LeBlanc explore the safety and efficacy of\u202ftagraxofusp\u202ffrom STML-401-0114 and real-world evidence, as well as how he approaches\u202foptimizing\u202fclinical management and\u202finterdisciplinary\u202fcare. Topics covered: How BPDCN presents and what steps are needed to make a correct diagnosis The safety and efficacy outcomes from STML-401-0114, including patient subgroups\u202fbased on patients\u2019 age, fitness, or baseline skin burden How real-world evidence complements\u202fthe findings from the pivotal STML-401-0114 study How the\u202f\u2018Prepare, Look, Apply, and Next\u202fSteps\u2019 (PLAN)\u202fmanagement framework can help your team monitor and manage adverse events Speaker: Thomas LeBlanc Division of Hematologic Malignancies and Cellular Therapy, Duke University School of Medicine,\u202fDurham, North Carolina,\u202fUSA   INDICATION Tagraoxfusp\u202fis a CD123-directed cytotoxin indicated for the treatment of\u202fblastic\u202fplasmacytoid dendritic cell neoplasm (BPDCN) in adults and in\u202fpediatric\u202fpatients 2 years and older   IMPORTANT SAFETY INFORMATION Boxed WARNING: CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS), which may be life-threatening or fatal, can occur in patients receiving\u202ftagraxofusp. Monitor for signs and symptoms of CLS and take actions as recommended.   WARNINGS AND PRECAUTIONS  Capillary Leak Syndrome Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported among patients treated with\u202ftagraxofusp. In patients receiving\u202ftagraxofusp\u202fin clinical trials, the overall incidence of CLS was 53% (65\/122), including Grade 1 or 2 in 43% (52\/122) of patients, Grade 3 in 7% (8\/122) of patients, Grade 4 in 1% (1\/122) of patients, and four fatalities (3%). The median time to onset was 4 days (range-1 to 46 days), and all but 5 patients experienced an event in Cycle 1. Before\u202finitiating\u202ftherapy with\u202ftagraxofusp, ensure that the patient has adequate cardiac function and serum albumin is greater than or equal to 3.2 g\/dL. During treatment with\u202ftagraxofusp,\u202fmonitor\u202fserum albumin levels prior to the initiation of each dose of\u202ftagraxofusp\u202fand as\u202findicated\u202fclinically thereafter, and assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening\u202fedema, including pulmonary\u202fedema,\u202fhypotension\u202for hemodynamic instability. Hypersensitivity Reactions Tagraxofusp\u202fcan cause severe hypersensitivity reactions. In patients receiving\u202ftagraxofusp\u202fin clinical trials, hypersensitivity reactions were reported in 43% (53\/122) of patients treated with\u202ftagraxofusp\u202fand were Grade \u2265 3 in 7% (9\/122). Manifestations of hypersensitivity reported in\u202f\u2265 5%\u202fof patients include rash, pruritus, and stomatitis. Monitor patients for hypersensitivity reactions during treatment with\u202ftagraxofusp. Interrupt\u202ftagraxofusp\u202finfusion and provide supportive care as needed if a hypersensitivity reaction should occur. Hepatotoxicity Treatment with\u202ftagraxofusp\u202fwas associated with elevations in liver enzymes. In patients receiving\u202ftagraxofusp in\u202fclinical trials, elevations in ALT occurred in 79%\u202f(96\/122) and elevations in AST occurred in 76% (93\/122). Grade 3 ALT elevations were reported in 26% (32\/122) of patients. Grade 3 AST elevations were reported in 30% (36\/122)\u202fand Grade 4 AST elevations were reported in 3% (4\/122) of patients. Elevated liver enzymes occurred in\u202fthe majority of\u202fpatients in Cycle 1 and were reversible following dose interruption. Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with\u202ftagraxofusp. Withhold\u202ftagraxofusp\u202ftemporarily if the transaminases rise to greater than 5 times the upper limit of normal and resume treatment upon normalization or when resolved. ADVERSE REACTIONS: Most common adverse reactions (incidence\u202f\u2265 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral\u202fedema, and weight increase. Most common laboratory abnormalities (incidence \u2265 50%) are decreases in albumin, platelets,\u202fhemoglobin, calcium, and sodium, and increases in glucose, ALT and AST. Please see Full Prescribing Information, including Boxed WARNING. To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at\u202f1-877-332-7961\u202for contact the FDA at\u202f1-800-FDA-1088\u202for\u202fwww.fda.gov\/medwatch. MED-05440 \/ \u00a9 2026 Stemline Therapeutics, Inc. All rights reserved. 07\/2026 ","author_name":"EMJ Podcast: Insights For Healthcare Professionals","author_url":"http:\/\/emghealthpodcast.libsyn.com\/website","html":"