---
title: "AbbVie seeks FDA approval for blood cancer treatment"
description: "AbbVie has submitted a new biologics license application to the US FDA for its investigational drug Pivekimab sunirine (PVEK) aimed at treating blast plasmacytoid dendritic cell neoplasm (BPDCN). This"
type: "news"
locale: "en"
url: "https://longbridge.com/en/news/259562252.md"
published_at: "2025-09-30T14:10:42.000Z"
---

# AbbVie seeks FDA approval for blood cancer treatment

> AbbVie has submitted a new biologics license application to the US FDA for its investigational drug Pivekimab sunirine (PVEK) aimed at treating blast plasmacytoid dendritic cell neoplasm (BPDCN). This application is based on data from the Phase 1/2 CADENZA trial, which assessed PVEK's safety and efficacy in treating this rare and aggressive blood cancer. The drug targets CD123, a protein overexpressed in BPDCN, and is also being developed for other hematologic malignancies.

AbbVie announces the submission of a new biologics license application to the US FDA for its investigational drug Pivekimab sunirine (PVEK) for the treatment of blast plasmacytoid dendritic cell neoplasm (BPDCN).

This application for approval is based on data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of PVEK in BPDCN, a rare and aggressive blood cancer that has characteristics of both leukemia and lymphoma.

First-line treatments are typically intensive chemotherapy, often followed by stem cell transplantation. There is a high need for additional and innovative treatments, the pharmaceutical group points out.

AbbVie's PEVK, an antibody-drug conjugate targeting CD123 (a protein overexpressed in BPDCN), is in clinical development for hematologic malignancies, including BPDCN and acute myeloid leukemia.

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> **Disclaimer**: This article is for reference only and does not constitute any investment advice.