BPDCN International Registry shared a post on LinkedIn:
“Yesterday, the FDA approved pivekimab sunirine‑pvzy (Decnupaz) for adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra‑rare and aggressive hematologic malignancy with very limited treatment options.
This CD123‑directed antibody-alkylating agent conjugate was approved based on the single‑arm, multicenter phase 1/2 CADENZA trial, which enrolled both treatment‑naïve and relapsed/refractory BPDCN without active CNS disease. In treatment‑naive adults, 69.7% achieved complete remission or clinical complete remission (CR/CRc), with a median CR/CRc duration of about 9–10 months at more than 21 months’ follow‑up. Responses were more modest in relapsed/refractory disease (CR/CRc 15.7%), but still clinically meaningful in a setting where options are extremely scarce.
For the BPDCN community-patients, clinicians, and researchers-this is a major milestone that formally adds a CD123‑targeted antibody–drug conjugate to our therapeutic toolkit. I am particularly interested in how pivekimab sunirine‑pvzy will be used in real‑world practice (frontline vs bridge to allo‑HSCT, post‑tagraxofusp, etc.) and how outcomes will compare to those from clinical trials.”
Other articles about BPDCN International Registry on OncoDaily.