Treats blastic plasmacytoid dendritic cell neoplasm (BPDCN). BLA 761460, held by Abbvie Inc. Pivekimab Sunirine-Pvzy.
As of Nov 13, 2026, BLA 761460 (Decnupaz), held by Abbvie Inc, was first approved by FDA on May 27, 2026, with 0 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE DECNUPAZ is indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). DECNUPAZ is a CD123-directed antibody and alkylating agent conjugate
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 27, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Decnupaz2MG · vial;single-dose | Pivekimab Sunirine-Pvzy | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
