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# AbbVie BLA for Treating Rare Blood Cancer
- URL: https://www.fdaweb.com/abbvie-bla-for-treating-rare-blood-cancer/
- Published: 2025-10-01T12:00:00.000Z
- Updated: 2026-09-14T15:23:06.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159971

AbbVie 9/30 submitted a BLA seeking approval for its investigational antibody-drug conjugate pivekimab sunirine (PVEK) to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive blood cancer.

The submission is based on data from AbbVie’s global Phase 1/2 CADENZA trial, which evaluated the safety and efficacy of PVEK in patients with BPDCN. Patients with BPDCN often present with skin lesions, and the disease can spread to bone marrow, lymph nodes, and the central nervous system, the company says. Standard treatments typically involve intensive chemotherapy followed by stem cell transplant, leaving significant unmet needs, especially for patients with relapsed or refractory disease.

AbbVie says PVEK is designed to target CD123, a protein overexpressed on BPDCN cells, to deliver potent anti-cancer agents directly to tumor cells. The therapy is also being investigated for acute myeloid leukemia, both as a monotherapy and in combination with AbbVie’s Vidaza (azacitidine) and Venclexta (venetoclax).

In 2020, the agency granted PVEK a breakthrough therapy designation for relapsed or refractory BPDCN.