FDA Approves Decnupaz for Blastic Plasmacytoid Dendritic Cell NeoplasmFDA approves new drug Decnupaz for rare blood cancer BPDCN

Decnupaz is a CD123-directed antibody and alkylating agent conjugate. The antibody binds to CD123-expressing cells, and after internalization, the alkylating agent is released to cause DNA damage and cell death.

Decnupaz is indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

The recommended dose is 0.045 mg/kg intravenously over approximately 15-30 minutes once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Premedicate with a corticosteroid (e.g., dexamethasone 8 mg twice daily) on the day prior to infusion, and with a corticosteroid (dexamethasone 8 mg IV), antihistamine (diphenhydramine 25-50 mg IV), and antipyretic (acetaminophen 325-650 mg oral) at least 30-60 minutes prior to infusion. Dose modifications are required for adverse reactions including veno-occlusive disease (permanently discontinue), increased AST/ALT or bilirubin (delay dosing), infusion-related reactions (interrupt, stop, or discontinue based on grade), edema (delay and consider dose reduction), and other Grade 3-4 non-hematologic adverse reactions (delay or discontinue).

Trial data not available in label.

Warnings include veno-occlusive disease (VOD), hepatotoxicity (increased AST/ALT or bilirubin), infusion-related reactions, and edema. For VOD of any grade, permanently discontinue Decnupaz. For AST or ALT >2.5 x ULN, delay dosing until ≤2.5 x ULN. For total bilirubin >1.5 x ULN, delay dosing until ≤1.5 x ULN. For infusion-related reactions, manage according to grade (interrupt, stop, or permanently discontinue). For edema, manage with diuretics and delay dosing; consider dose reduction if delayed >2 weeks. No contraindications are listed in the label.

Decnupaz is a targeted therapy for adult patients with BPDCN, a rare disease with limited treatment options. It is administered intravenously every 3 weeks with required premedication. Monitoring for VOD, hepatotoxicity, infusion reactions, and edema is essential.