---
title: "艾伯維尋求美國食品藥品監督管理局批准其血癌治療方案"
description: "艾伯維已向美國 FDA 提交了其研究藥物 Pivekimab sunirine（PVEK）的新生物製品許可申請，旨在治療爆發性漿細胞樣樹突狀細胞腫瘤（BPDCN）。該申請基於 1/2 期 CADENZA 試驗的數據，該試驗評估了 PVEK 在治療這種罕見且侵襲性血癌中的安全性和有效性。該藥物靶向 CD123，這是一種在 BPDCN 中過度表達的蛋白質，同時也正在開發用於其他血液惡性腫瘤"
type: "news"
locale: "zh-HK"
url: "https://longbridge.com/zh-HK/news/259562252.md"
published_at: "2025-09-30T14:10:42.000Z"
---

# 艾伯維尋求美國食品藥品監督管理局批准其血癌治療方案

> 艾伯維已向美國 FDA 提交了其研究藥物 Pivekimab sunirine（PVEK）的新生物製品許可申請，旨在治療爆發性漿細胞樣樹突狀細胞腫瘤（BPDCN）。該申請基於 1/2 期 CADENZA 試驗的數據，該試驗評估了 PVEK 在治療這種罕見且侵襲性血癌中的安全性和有效性。該藥物靶向 CD123，這是一種在 BPDCN 中過度表達的蛋白質，同時也正在開發用於其他血液惡性腫瘤

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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