<div id="readability-page-1"><div><div><p>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).</p><p>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.</p><p>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.</p><p>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.</p></div></div></div>

艾伯維

<p>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</p>

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