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The FDA has approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a first-in-class CD123-directed antibody and alkylating agent conjugate, for the treatment of adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
The approval, which followed breakthrough designation, orphan drug designation, and priority review, was based on efficacy demonstrated in the open-label, single-arm CADENZA trial of patients with BPDCN — an ultra-rare and aggressive hematologic malignancy.
Complete remission or clinical CR (CR/CRc) occurred in 23 of 33 treatment-naive patients (69.7%) and eight of 51 patients with relapsed or refractory BPDCN (15.7%), according to the FDA notice. The median duration of follow-up was 21.5 months and 24.1 months, and the median duration of CR/CRc was 9.7 months and 9.2 months in the groups, respectively.
Prescribing information, which will be posted on Drugs@FDA, includes a Boxed Warning for hepatotoxicity, including hepatic veno-occlusive disease, and warnings and precautions for infusion-related reactions, edema, sulfite allergic reactions, and embryo-fetal toxicity.
The recommended dose of pivekimab sunirine-pvzy is 0.045 mg/kg — calculated based on each patient’s actual body weight — given intravenously over 15-30 minutes once every 3 weeks until disease progression or unacceptable toxicity.
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on X: @SW_MedReporter.
