<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>

艾伯维

<p>艾伯维已向美国 FDA 提交了其研究药物 Pivekimab sunirine（PVEK）的新生物制品许可申请，旨在治疗爆发性浆细胞样树突状细胞肿瘤（BPDCN）。该申请基于 1/2 期 CADENZA 试验的数据，该试验评估了 PVEK 在治疗这种罕见且侵袭性血癌中的安全性和有效性。该药物靶向 CD123，这是一种在 BPDCN 中过度表达的蛋白质，同时也正在开发用于其他血液恶性肿瘤</p>

艾伯维寻求美国食品药品监督管理局批准其血癌治疗方案