皮埃尔·法布尔制药公司宣布，美国食品药品监督管理局（FDA）已接受并优先审查用于治疗EB病毒阳性移植后淋巴增殖性疾病（EBV+ PTLD）的Tabelecleucel生物制品许可申请（BLA）-动脉网

Pierre Fabre Pharmaceuticals Inc. Announces FDA Acceptance and Priority Review of the Biologics License Application (BLA) for Tabelecleucel for the Treatment of Epsteinarr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)

CISION 等信源发布 2025-07-24 20:57

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First allogeneic T-Cell therapy BLA offers hope to EBV+ PTLD patients who have limited treatment options and lifespan measured in only a few weeks to months following failure of initial treatment

首次异基因T细胞疗法生物制品许可申请（BLA）为EBV+ PTLD患者带来了希望，这些患者在初始治疗失败后，治疗选择有限，生存期仅剩几周到几个月。

EBV+ PTLD is an ultra-rare, acute, and potentially deadly blood malignancy that occurs after hematopoietic cell transplant (HCT) or solid organ transplant (SOT) when T-cell activity is impaired by immunosuppression

EBV+ PTLD 是一种超罕见、急性且可能致命的血液恶性肿瘤，发生在造血细胞移植 (HCT) 或实体器官移植 (SOT) 后，当免疫抑制导致 T 细胞活性受损时出现。

Tabelecleucel has a Prescription Drug User Fee Act (PDUFA) target action date of

Tabelecleucel 的《处方药使用者费用法案》（PDUFA）目标行动日期为

January 10, 2026

2026年1月10日

and would be the first approved therapy in the U.S. for EBV+ PTLD

并且将成为美国首个获批的EBV+ PTLD疗法

SECAUCUS, N.J.

新泽西州塞考克斯

，

July 24, 2025

2025年7月24日

/PRNewswire/ -- Pierre Fabre Pharmaceuticals Inc. (PFP) announces the acceptance by U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) and Priority Review of tabelecleucel, indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy..

/PRENewswire/ -- 皮埃尔·法布雷制药公司（PFP）宣布，美国食品药品监督管理局（FDA）已接受tabelecleucel的生物制品许可申请（BLA），并给予优先审查。该药物适用于治疗两岁及以上、曾接受过至少一种先前疗法的爱泼斯坦-巴尔病毒阳性移植后淋巴增殖性疾病（EBV+ PTLD）的成人和儿童患者，作为单药治疗。

Atara Biotherapeutics Inc. (Nasdaq:

阿塔拉生物治疗公司 (纳斯达克:

ATRA

全反式维甲酸

) resubmitted the tabelecleucel BLA on

重新提交了塔贝莱塞鲁塞尔生物制品许可申请（BLA）

July 11

7月11日

, having in collaboration with PFP, swiftly addressed the third-party manufacturing facility observations outlined in the

，与PFP合作，迅速处理了第三方制造设施中提到的观察结果。

January 2025

2025年1月

Complete Response Letter.

完全回应信。

'Patients diagnosed with relapsed or refractory EBV+ PTLD have no approved FDA treatment options, and following failure of initial therapy their survival is unfortunately measured in only weeks to months. Today's BLA acceptance gives hope to these patients and is a significant step towards making this innovative cell therapy available in .

“被诊断为复发或难治性EBV+ PTLD的患者目前尚无FDA批准的治疗方案，初始治疗失败后，他们的生存期不幸仅以数周到数月来计算。今天BLA的受理为这些患者带来了希望，这也是推动这种创新细胞疗法上市的重要一步。

the United States

美国

,' said

`，' 说

Adriana Herrera

阿德里安娜·埃雷拉

, Chief Executive Officer of PFP, the Pierre Fabre Laboratories Pharmaceutical subsidiary in the U.S. 'We are now completely focused on preparing for potential FDA approval of this innovative new treatment option.'

美国PFP（皮尔法伯实验室制药子公司）首席执行官表示：“我们现在正全力以赴，为这种创新的新治疗方案潜在获得FDA批准做准备。”

Tabelecleucel is an allogeneic, off the shelf, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells. The BLA includes data covering more than 430 patients treated with tabelecleucel including the ongoing pivotal ALLELE study investigating the therapy in adults and children two years of age and older with relapsed or refractory EBV+ PTLD following SOT or HCT..

Tabelecleucel是一种同种异体、现成的、针对EBV的T细胞免疫疗法，可靶向并消除EBV感染的细胞。生物制品许可申请（BLA）包含涵盖430多名接受过tabelecleucel治疗的患者的数据，其中包括正在进行的关键性ALLELE研究，该研究针对接受过实体器官移植（SOT）或造血细胞移植（HCT）后复发或难治性EBV+ PTLD的成人和两岁及以上儿童展开。

Tabelecleucel was granted marketing authorization under the brand name EBVALLO™ in

Tabelecleucel 已获得品牌名称 EBVALLO™ 的上市许可。

December 2022

2022年12月

by the European Commission (EC). Marketing authorization was also granted by the Medicines and Healthcare Products Regulatory Agency in the

由欧洲委员会 (EC) 授予。药品和健康产品监管局也授予了上市许可，在

United Kingdom

英国

在

May 2023

2023年5月

and by Swissmedic in

并由瑞士医药管理局在

Switzerland

瑞士

在

May 2024

2024年5月

。

Since

自从

March 31, 2025

2025年3月31日

, PFP has assumed global responsibility for tabelecleucel manufacturing of commercial product for European markets and for global clinical trial supply. On

，PFP已承担起为欧洲市场制造塔贝莱塞细胞商业化产品的全球责任，并负责全球临床试验供应。

July 15, 2025

2025年7月15日

, Atara Biotherapeutics transferred the tabelecleucel Investigational New Drug Application to Pierre Fabre Medicament, a subsidiary of Pierre Fabre Laboratories. As per the terms of the restated exclusive worldwide licensing agreement between Atara and Pierre Fabre Laboratories announced in

，Atara Biotherapeutics 将 tabelecleucel 的新药临床试验申请转让给了 Pierre Fabre 实验室的子公司 Pierre Fabre Medicament。根据 Atara 和 Pierre Fabre 实验室之间宣布的经修订的全球独家许可协议条款规定。

November 2023

2023年11月

, Atara is responsible for regulatory procedures up until BLA transfer to Pierre Fabre Pharmaceuticals.

，Atara 负责监管程序，直到 BLA 转移至皮埃尔·法布雷制药公司。

About Pierre Fabre Pharmaceuticals and Pierre Fabre Laboratories

关于皮埃尔·法布尔制药公司和皮埃尔·法布尔实验室

The mission of PFP is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet needs and limited treatment options. Our belief is that every time we care for a single person, we make the whole world better.

PFP 的使命是为在肿瘤学和罕见疾病领域中存在高度未满足需求和治疗选择有限的患者群体提供突破性疗法。我们相信，每次关怀一个人，都会让整个世界变得更美好。

PFP is the US pharmaceutical subsidiary of Pierre Fabre Laboratories, a foundation-owned company with seven decades of impact. Pierre Fabre Laboratories is a global healthcare company, established in 43 countries, with over 10,000 employees, and with products distributed in 120 territories across the globe..

PFP是皮埃尔·法布雷实验室的美国制药子公司，这家公司由基金会所有，拥有七十年的影响力。皮埃尔·法布雷实验室是一家全球性医疗保健公司，在43个国家开展业务，拥有超过10,000名员工，产品遍布全球120个地区。

The Pierre Fabre Laboratories foundation ownership enhances the ability of the company to create long-term value for patients. Partnerships and acquisitions drive its innovative precision treatment pipeline and are enabled by the unique corporate structure.

皮埃尔·法布雷实验室的基金会所有权增强了公司为患者创造长期价值的能力。合作伙伴关系和收购推动了其创新的精准治疗管道，并受到独特企业结构的支持。

Building on the legacy of Pierre Fabre Laboratories, innovation is the life blood of PFP, and patient experience drives everything the company does. PFP aspires to design and develop therapeutic solutions inspired by patients and healthcare professionals; draw on science and nature as perpetual sources of inspiration; develop long-term partnerships with researchers and innovators worldwide; and place pharmaceutical ethics and climate transition at the heart of our action..

基于皮埃尔·法布尔实验室的传承，创新是PFP的生命线，患者体验驱动着公司的所有行动。PFP致力于设计和开发受患者和医疗专业人员启发的治疗方案；以科学和自然为永恒的灵感源泉；与全球研究人员和创新者建立长期合作关系；并将医药伦理与气候转型置于我们行动的核心。

Pierre Fabre Pharmaceuticals has therapies in development for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), NRAS-mutant melanoma, non-small cell lung cancer with mutation or amplification of MET, and X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED). Pierre Fabre Pharmaceuticals is headquartered in .

皮埃尔·法布尔制药公司正在开发针对Epstein-Barr病毒阳性移植后淋巴增殖性疾病（EBV+ PTLD）、NRAS突变黑色素瘤、MET突变或扩增的非小细胞肺癌以及X连锁低汗性外胚层发育不良（XLHED）的疗法。皮埃尔·法布尔制药公司的总部位于。

Secaucus, NJ

新泽西州锡考克斯

。

For more information, visit

欲了解更多信息，请访问

www.pierrefabrepharmaceuticals.com

，

www.pierre-fabre.com

，

@Pierre Fabre Oncology.

@皮埃尔·法布尔肿瘤学。