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Elzonris™ FDA approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN)
By: News Feed | Last updated: 27th December 2018 | In: Haematology, Oncology, Paediatric, US FDA Onc\Haem Approvals
Article Keywords
blastic plasmacytoid dendritic cell neoplasm, BPDCN, CD123, cytotoxin, Elzonris, FDA, Stemline Therapeutics, tagraxofusp
On 21 December 2018, the FDA approved the CD123-directed cytotoxin tagraxofusp-erzs (Elzonris™, Stemline Therapeutics), for the treatment of adult and paediatric patients of 2 years and older with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
STML-401-0114
The multicentre, multicohort, open-label, single-arm STML-401-0114 study (NCT02113982) enrolled a total of 28 untreated or relapsed/refractory (R/R) BPDCN patients in two cohorts. In the cohort (N=13) with untreated BPDCN patients and at a median follow-up of 11.5 months, 53.8% (7/13) of subjects achieved a (clinical) complete response (CR; 95% CI, 25.1-80.8). The median duration of response was not yet reached. In the cohort including R/R BPDCN patients (N=15), one patient achieved a CR with a duration of 111 days and one patient had a clinical CR lin with a duration of 424 days.
Safety
Common adverse reactions in ≥30% of patients included capillary leak syndrome, nausea, fatigue, peripheral oedema, pyrexia, and weight increase. Common laboratory abnormalities in ≥50% of patients were decreases in albumin, platelets, haemoglobin, calcium, and sodium, as well as increases in glucose, alanine transaminase (ALT) and aspartate transaminase (AST).
Disclaimer
This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
© Copyright 2018 MediPaper Medical Communications Ltd.
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