THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that the U.S.

加利福尼亚州千橡树市（商业新闻短讯）--T细胞免疫疗法的领导者Atara Biotherapeutics，Inc.（纳斯达克：ATRA），利用其新型同种异体爱泼斯坦-巴尔病毒（EBV）T细胞平台为癌症和自身免疫性疾病患者开发转化疗法，今天宣布美国。

Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for tabelecleucel (tab-cel®) 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.

美国食品和药物管理局（FDA）已接受tabelecleucel（tab cel®）生物制剂许可证申请（BLA）的备案，该申请被指示为单一疗法，用于治疗2岁及以上爱泼斯坦-巴尔病毒阳性移植后淋巴增生性疾病（EBV+PTLD）的成人和儿科患者，他们至少接受过一次治疗。

For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. There are no FDA approved therapies in this treatment setting..

对于实体器官移植患者，除非化疗不合适，否则先前的治疗包括化疗。在这种治疗环境中，没有FDA批准的疗法。。

The BLA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2025.

《处方药使用费法案》（PDUFA）的目标行动日期为2025年1月15日，已授予BLA优先审查权。

“The acceptance of the tab-cel BLA is a significant milestone towards making this first-of-its-kind treatment available to patients in the U.S.,” said Pascal Touchon, President and Chief Executive Officer of Atara. “The FDA’s granting of priority review highlights the high unmet need in EBV+ PTLD, which is a devastating disease with limited treatment options and a poor overall survival rate.

Atara总裁兼首席执行官帕斯卡·特肯（PascalTouchon）表示：“tab-cel-BLA的接受是向美国患者提供此类治疗的一个重要里程碑。”。“FDA批准的优先审查突显了EBV+PTLD的高度未满足需求，这是一种毁灭性疾病，治疗选择有限，总体生存率很低。

We continue to work closely with the Pierre Fabre Laboratories team to help prepare for the potential launch in the U.S. in early 2025, along with the potential label expansion multicohort Phase 2 EBVision trial.”.

我们继续与Pierre Fabre实验室团队密切合作，以帮助为2025年初在美国的潜在推出做好准备，以及潜在的标签扩展Multichort 2期EBVision试验。”。

Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA is supported by pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases including the latest pivotal ALLELE study data that demonstrated a statistically significant 48.8% Objective Response Rate (ORR) (p<0.0001) and favorable safety profile consistent with previous analyses..

。BLA得到了关键和支持性数据的支持，这些数据涵盖了430多名接受tab-cel治疗的多种危及生命的疾病患者，包括最新的关键等位基因研究数据，这些数据显示客观缓解率（ORR）为48.8%，具有统计学意义（p<0.0001），安全性良好，与之前的分析一致。。

Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation.

Tab-cel已被美国FDA授予用于治疗利妥昔单抗难治性EBV相关淋巴增生性疾病的突破性治疗指定，并具有孤儿药指定。

In December 2023, Atara announced the closing of the expanded global partnership with Pierre Fabre Laboratories for the U.S. and remaining global commercial markets for tab-cel, building on an initial partnership covering Europe, Middle East, Africa, and other select emerging markets. With the acceptance of the tab-cel BLA, Atara will receive a $20 million milestone payment from Pierre Fabre, with the potential to receive a $60 million milestone payment from Pierre Fabre contingent upon FDA approval of the tab-cel BLA.

2023年12月，Atara宣布与Pierre Fabre Laboratories在美国和tab cel剩余的全球商业市场建立扩大的全球合作伙伴关系，建立在涵盖欧洲、中东、非洲和其他选定新兴市场的初始合作伙伴关系的基础上。随着tab cel BLA的接受，Atara将从Pierre Fabre获得2000万美元的里程碑付款，并有可能从Pierre Fabre获得6000万美元的里程碑付款，这取决于FDA批准tab cel BLA。

In addition, Pierre Fabre is reimbursing Atara for expected tab-cel global development costs through the BLA transfer and purchasing tab-cel inventory through the manufacturing transfer date. Atara is also eligible to receive sales milestones and double-digit tiered royalties on net sales of tab-cel in the U.S.

此外，皮埃尔·法布尔（Pierre Fabre）正在通过BLA转移和采购tab cel库存，在制造转移日期偿还Atara的预期tab cel全球开发成本。Atara也有资格获得tab cel在美国净销售额的销售里程碑和两位数的分层版税。

and remaining global commercial markets referenced above..

以及上述剩余的全球商业市场。。

Tab-cel was granted marketing authorization under the brand name Ebvallo™ in December 2022 by the European Commission. Marketing authorization was also granted by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in May 2023 and by Swissmedic in Switzerland in May 2024. In all three territories, Ebvallo is indicated as monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory EBV+ PTLD who have received at least one prior therapy.

。2023年5月，英国药品和保健品管理局（Medicines and Healthcare Products Regulatory Agency）和瑞士瑞士医学会（Swissmedic）分别授予了上市许可。在所有三个地区，Ebvallo被指定为单一疗法，用于治疗至少接受过一次治疗的复发或难治性EBV+PTLD的2岁及以上成人和儿科患者。

For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. Ebvallo was awarded the 2024 Prix Galien International Award for “Best Product for Orphan/Rare Diseases.”.

对于实体器官移植患者，除非化疗不合适，否则先前的治疗包括化疗。埃巴洛因“孤儿/罕见疾病最佳产品”获得2024年加利恩国际大奖。

About Atara Biotherapeutics, Inc.

关于Atara Biotherapeutics，Inc。

Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy.

Atara正在利用免疫系统的天然力量开发现成的细胞疗法，用于治疗难以治疗的癌症和自身免疫性疾病，这些疾病可以从库存中快速传递给患者。凭借尖端科学和差异化方法，Atara是世界上第一家获得同种异体T细胞免疫疗法监管批准的公司。

Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases, in addition to next-generation AlloCAR-Ts designed for best-in-class opportunities across a broad range of hematological malignancies and B-cell driven autoimmune diseases.

我们先进且多功能的T细胞平台不需要T细胞受体或HLA基因编辑，并且形成了针对EBV（某些疾病的根本原因）的多种研究疗法组合的基础，此外还设计了下一代AlloCAR Ts，用于在广泛的血液恶性肿瘤和B细胞驱动的自身免疫性疾病中获得最佳机会。

Atara is headquartered in Southern California. For more information, visit atarabio.com and follow @Atarabio on X and LinkedIn..

阿塔拉总部位于南加州。有关更多信息，请访问atarabio.com并在X和LinkedIn上关注@atarabio。。