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Arvinas和辉瑞Vepdegestrant(ARV-471)获得FDA快速通道指定,用于治疗ER+/HER2-转移性乳腺癌患者

Arvinas and Pfizer’s Vepdegestrant (ARV-471) Receives FDA Fast Track Designation for the Treatment of Patients with ER+/HER2- Metastatic Breast Cancer

GlobeNewswire 等信源发布 2024-02-06 19:45

可切换为仅中文


-- Vepdegestrant is an investigational PROteolysis Targeting Chimera (PROTAC®) protein degrader designed to target and degrade the estrogen receptor (ER) protein -- NEW HAVEN, Conn. and NEW YORK, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced that the U.S.

--Vepdegestrant是一种针对嵌合体(PROTAC®)蛋白降解剂的研究性蛋白水解剂,旨在靶向和降解雌激素受体(ER)蛋白——康涅狄格州纽黑文和纽约,2024年2月6日(环球通讯社)——Arvinas,Inc.(纳斯达克股票代码:ARVN)和辉瑞公司(纽约证券交易所代码:PFE)今天宣布,美国。

Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of vepdegestrant (ARV-471) for monotherapy in the treatment of adults with estrogen receptor (ER) positive/human growth epidermal growth factor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer previously treated with endocrine-based therapy.

美国食品和药物管理局(FDA)已经批准了vepdegestrant(ARV-471)单药治疗雌激素受体(ER)阳性/人生长表皮生长因子2(HER2)阴性(ER+/HER2-)成人的快速通道指定,用于研究先前接受内分泌治疗的局部晚期或转移性乳腺癌。

Vepdegestrant is a novel oral PROteolysis Targeting Chimera (PROTAC®) ER degrader that is being jointly developed by Arvinas and Pfizer. As described by the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Vepdegestrant是一种新型口服蛋白水解靶向嵌合体(PROTAC®)ER降解剂,由Arvinas和辉瑞公司联合开发。正如FDA所描述的那样,快速通道是一个旨在促进开发和加速药物审查的过程,以治疗严重疾病并满足未满足的医疗需求。

The purpose is to get important new drugs to patients earlier. Vepdegestrant as a monotherapy is being studied in the ongoing Phase 3 VERITAC-2 clinical trial, which is evaluating vepdegestrant or fulvestrant in patients with locally advanced or metastatic ER+/HER2- breast cancer who have been previously treated with an endocrine-based therapy.

目的是尽早向患者提供重要的新药。Vepdegestrant作为一种单一疗法正在正在进行的3期VERITAC-2临床试验中进行研究,该试验正在评估Vepdegestrant或氟维司群治疗局部晚期或转移性ER+/HER2乳腺癌患者,这些患者以前曾接受过内分泌治疗。

'We are focused on the persisting unmet needs of people with ER+/HER2- breast cancer and doing all that we can to expedite the development of vepdegestrant as a novel, oral ER-targeted potential therapy for this patient community,” said John Houston, Ph.D., Arvinas Chairperson, Chief Executive Officer, and President.

“我们专注于ER+/HER2乳腺癌患者持续未满足的需求,并尽一切努力加快vepdegestrant的发展,作为针对该患者社区的新型口服ER靶向潜在疗法,”约翰·休斯顿博士,Arvinas主席,首席执行官兼总裁说。

“We are pleased the FDA has granted Fast Track designation for vepdegestrant, and we continue to believe this investigational drug has th.

“我们很高兴FDA批准了vepdegestrant的快速通道,我们仍然相信这种研究药物具有th。