PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.

普林斯顿，新泽西州（商业新闻短讯）--百时美施贵宝（纽约证券交易所：BMY）今天宣布，美国食品和药物管理局（FDA）已批准加速批准Breyanzi®（lisocabtagene-Maraluecel；liso-cel），一种CD19定向嵌合抗原受体（CAR）T细胞疗法，用于治疗接受过两种或更多种全身治疗的复发或难治性滤泡性淋巴瘤（FL）成年患者。

This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Breyanzi is also now included in the National Comprehensive Cancer Network (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-cell Lymphomas as a Category 2A recommendation for third-line and subsequent therapy for relapsed or refractory FL.*.

根据响应率和响应持续时间，该适应症在加速批准下获得批准。继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。Breyanzi现在也被纳入国家综合癌症网络（NCCN®）肿瘤学临床实践指南（NCCN Guidelines®），作为B细胞淋巴瘤的2A类推荐，用于复发或难治性FL的三线治疗和后续治疗。*。

In relapsed or refractory FL, Breyanzi is delivered as a one-time infusion** with a single dose containing 90 to 110 x 106 CAR-positive viable T cells. Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities, and Secondary Hematological Malignancies..

在复发或难治性FL中，Breyanzi作为一次性输注**递送，单剂量含有90至110×106个CAR阳性活T细胞。请参阅下面的重要安全信息部分，包括Breyanzi关于细胞因子释放综合征（CRS），神经毒性和继发性血液系统恶性肿瘤的盒装警告。。

“Breyanzi is a cornerstone of our cell therapy portfolio, providing a differentiated profile across a wide array of B-cell malignancies,” said Bryan Campbell, senior vice president, Head of Commercial, Cell Therapy, Bristol Myers Squibb. “Today’s approval of Breyanzi for relapsed or refractory FL provides an option with potential for lasting remission in a one-time infusion and a safety profile that allows for administration and monitoring in both the inpatient and outpatient setting in an increasing number of certified treatment centers in the U.S.”.

百时美施贵宝（Bristol-Myers Squibb）高级副总裁、商业、细胞治疗负责人布莱恩·坎贝尔（BryanCampbell）表示：“布雷扬兹（Breyanzi）是我们细胞治疗组合的基石，在各种B细胞恶性肿瘤中提供了不同的概况。”。“今天Breyanzi对复发或难治性FL的批准提供了一种选择，可以一次性输注持续缓解，并且具有安全性，可以在美国越来越多的认证治疗中心的住院和门诊环境中进行管理和监测。”。

Historically, FL has been considered an incurable disease, and patients frequently relapse following front-line therapy, with prognosis worsening after each subsequent relapse. Despite advances in treatment, there remains an unmet need for additional options that offer treatment-free intervals with durable, complete responses..

从历史上看，FL被认为是一种无法治愈的疾病，患者在一线治疗后经常复发，每次复发后预后恶化。尽管治疗取得了进展，但仍然需要额外的选择，以提供持久，完整的反应的无治疗间隔。。

The Phase 2 TRANSCEND FL study included the largest primary analysis set of patients with relapsed or refractory FL of a clinical trial evaluating a CAR T cell therapy in this patient population. Based on the U.S. Prescribing Information (USPI), in patients treated with Breyanzi in the third-line plus setting and included in the primary efficacy analysis set (n=94), the overall response rate (ORR) was 95.7% (95% CI: 89.5-98.8).

2期TRANSCEND FL研究包括临床试验中复发或难治性FL患者的最大主要分析集，该临床试验评估了该患者群体中的CAR T细胞疗法。根据美国处方信息（USPI），在第三线加治疗并纳入主要疗效分析集（n=94）的Breyanzi患者中，总有效率（ORR）为95.7%（95%CI:89.5-98.8）。

ORR was defined as the percentage of patients achieving a partial or complete response per Lugano criteria as assessed by an Independent Review Committee (IRC). The complete response (CR) rate was 73.4% (95% CI: 63.3-82.0) and required a negative bone marrow biopsy for confirmation. Responses were rapid and durable with a median time to response of one month (range: 0.6-3.3) and median duration of response (DOR) not reached (95% CI: 18.04-NR), with 80.9% of responders remaining in response at 12 months, and 77.1% of responders remaining in response at 18 months.

ORR定义为根据独立审查委员会（IRC）评估的卢加诺标准达到部分或完全缓解的患者百分比。完全缓解率（CR）为73.4%（95%CI:63.3-82.0），需要骨髓活检阴性才能确诊。反应迅速且持久，中位反应时间为一个月（范围：0.6-3.3），中位反应持续时间（DOR）未达到（95%CI:18.04-NR），其中80.9%的反应者在12个月时仍有反应，77.1%的反应者在18个月时仍有反应。

Results from the primary analysis of TRANSCEND FL presented at the 2023 International Conference on Malignant Lymphoma showed an ORR of 97% (95% CI: 91.6-99.4; one-sided p<0.0001) in efficacy evaluable patients (n=101), with 94% of patients achieving a CR (95% CI: 87.5-97.8; one-sided p<0.0001)..

2023年国际恶性淋巴瘤会议上发表的TRANSCEND FL初步分析结果显示，可评估疗效的患者（n=101）的ORR为97%（95%CI:91.6-99.4；单侧p＜0.0001），94%的患者达到CR（95%CI:87.5-97.8；单侧p＜0.0001）。。

“In the treatment of relapsed or refractory follicular lymphoma, patients often cycle through treatments with typically shorter responses with each new line of therapy. Those who have experienced early disease progression have notably poor prognosis,” said M. Lia Palomba, M.D., TRANSCEND investigator and lymphoma and cell therapy specialist, Memorial Sloan Kettering Cancer Center.

“在复发或难治性滤泡性淋巴瘤的治疗中，患者通常通过每种新的治疗方案进行周期性治疗，通常反应较短。那些经历过早期疾病进展的患者预后明显较差，”纪念斯隆·凯特琳癌症中心TRANSCEND研究者兼淋巴瘤和细胞治疗专家M.Lia Palomba医学博士说。

“The FDA approval of liso-cel for patients with relapsed or refractory FL is an important advancement in addressing an ongoing unmet need in the FL treatment paradigm, providing patients a new option that has shown remarkably high response rates and an established safety profile.”.

“FDA批准liso cel治疗复发或难治性FL患者是解决FL治疗范式中持续未满足需求的重要进展，为患者提供了一种新的选择，显示出非常高的反应率和既定的安全性。”。

Breyanzi has exhibited a consistent safety profile and across clinical trials, any grade cytokine release syndrome (CRS) occurred in 53% of patients, including Grade >3 CRS in 4% of patients. The median time to onset was 5 days (range: 1 to 63 days). Any grade neurologic events (NEs) occurred in 31% of patients, with Grade >3 NEs occurring in 10% of patients.

Breyanzi表现出一致的安全性，在整个临床试验中，53%的患者发生任何级别的细胞因子释放综合征（CRS），其中4%的患者发生>3级CRS。中位发病时间为5天（范围：1至63天）。31%的患者发生任何级别的神经系统事件（NEs），10%的患者发生>3级NEs。

The median time to onset of NEs was 8 days (range: 1 to 63 days). The safety profile of Breyanzi allows for the option of outpatient treatment and management of patients. Patients in the TRANSCEND FL study were treated in the inpatient and outpatient setting..

NEs发病的中位时间为8天（范围：1至63天）。Breyanzi的安全性允许选择门诊治疗和患者管理。TRANSCEND FL研究中的患者在住院和门诊治疗。。

“The lymphoma community has felt an urgent need for advancements in the treatment of relapsed or refractory follicular lymphoma,” said Meghan Gutierrez, chief executive officer, Lymphoma Research Foundation. “The approval of Breyanzi offers patients a new and meaningful treatment option that provides hope for lasting remission, and we are grateful to those who have contributed to this exciting milestone for patients.”.

淋巴瘤研究基金会首席执行官梅根·古铁雷斯（MeghanGutierrez）说：“淋巴瘤界迫切需要在复发或难治性滤泡性淋巴瘤的治疗方面取得进展。”。“Breyanzi的批准为患者提供了一种新的有意义的治疗选择，为持续缓解提供了希望，我们感谢那些为患者这一激动人心的里程碑做出贡献的人。”。

Bristol Myers Squibb offers various programs and resources to address the needs of patients and caregivers, and provides support that allows for access to therapies, including Breyanzi. Bristol Myers Squibb also supports the patient and physician treatment experience by providing Cell Therapy 360, a digital service platform, which optimizes access to relevant information, manufacturing updates, and patient and caregiver support..

百时美施贵宝（Bristol-Myers Squibb）提供各种计划和资源，以满足患者和护理人员的需求，并提供支持，使他们能够获得包括Breyanzi在内的治疗。百时美施贵宝还通过提供数字服务平台Cell Therapy 360来支持患者和医生的治疗体验，该平台优化了对相关信息、制造更新以及患者和护理人员支持的访问。。

*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

*NCCN对其内容、使用或应用不作任何形式的保证，也不以任何方式对其应用或使用承担任何责任。

**Treatment process includes leukapheresis, manufacturing, administration, and adverse event monitoring.

**治疗过程包括白细胞分离术，制造，给药和不良事件监测。

About TRANSCEND FL

关于超越FL

TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma. The primary outcome measure is overall response rate, including best overall response of complete response or partial response as determined by an Independent Review Committee.

TRANSCEND FL（NCT04245839）是一项开放标签的全球多中心2期单臂研究，旨在确定Breyanzi在复发或难治性惰性B细胞非霍奇金淋巴瘤（包括滤泡性淋巴瘤）患者中的疗效和安全性。主要结果指标是总体回应率，包括由独立审查委员会确定的完全回应或部分回应的最佳总体回应。

Secondary outcome measures include complete response rate, duration of response, progression-free survival, and safety..

次要结局指标包括完全缓解率，缓解持续时间，无进展生存期和安全性。。

About FL

关于FL

Follicular lymphoma (FL) is the second most common form of non-Hodgkin lymphoma (NHL) and the most common subtype of indolent NHL, accounting for 20 to 30 percent of all NHL cases. The average age of diagnosis for FL is 65 years of age. FL develops when white blood cells cluster together to form lumps in a person’s lymph nodes or organs.

滤泡性淋巴瘤（FL）是非霍奇金淋巴瘤（NHL）的第二种最常见形式，也是惰性NHL的最常见亚型，占所有NHL病例的20%至30%。FL的平均诊断年龄为65岁。当白细胞聚集在一起在人的淋巴结或器官中形成肿块时，FL就会发展。

It is characterized by periods of remission and relapse, and the disease becomes more difficult to treat after relapse or disease progression..

它的特征是缓解期和复发期，复发或疾病进展后疾病变得更加难以治疗。。

About Breyanzi

关于Breyanzi

Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment..

Breyanzi是一种CD19定向的CAR T细胞疗法，具有4-1BB共刺激结构域，可增强CAR T细胞的扩增和持久性。Breyanzi由患者自己的T细胞制成，这些T细胞被收集并进行基因重组，成为CAR T细胞，然后通过输注作为一次性治疗。。

Breyanzi is approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy and received accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines of therapy.

Breyanzi在美国被批准用于治疗至少一种先前的治疗方案后复发或难治性大B细胞淋巴瘤（LBCL），并在至少两种先前的治疗方案后获得加速批准用于治疗复发或难治性慢性淋巴细胞白血病或小淋巴细胞淋巴瘤。

Breyanzi is also approved in Japan, the European Union (EU), and Switzerland for the second-line treatment or relapsed or refractory LBCL, and in Japan, the European Union, Switzerland, the UK and Canada for relapsed and refractory LBCL after two or more lines of systemic therapy..

Breyanzi在日本，欧盟（EU）和瑞士也被批准用于二线治疗或复发或难治性LBCL，在日本，欧盟，瑞士，英国和加拿大也被批准用于两种或两种以上全身治疗后的复发和难治性LBCL。。

Bristol Myers Squibb’s clinical development program for Breyanzi includes clinical studies in other types of lymphoma. For more information, visit clinicaltrials.gov.

百时美施贵宝针对Breyanzi的临床开发计划包括其他类型淋巴瘤的临床研究。有关更多信息，请访问clinicaltrials.gov。

Indication

指示

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

BREYANZI是一种CD19定向的基因修饰自体T细胞免疫疗法，用于治疗：

adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:

成人大B细胞淋巴瘤（LBCL）患者，包括未另行说明的弥漫性大B细胞淋巴瘤（DLBCL）（包括由惰性淋巴瘤引起的DLBCL），高度B细胞淋巴瘤，原发性纵隔大B细胞淋巴瘤和滤泡性淋巴瘤3B级，他们有：

refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or

一线化学免疫治疗难治性疾病或一线化学免疫治疗后12个月内复发；或

refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or

一线化学免疫治疗难治性疾病或一线化学免疫治疗后复发，由于合并症或年龄，不符合造血干细胞移植（HSCT）的条件；或

relapsed or refractory disease after two or more lines of systemic therapy.

两种或多种全身治疗后复发或难治性疾病。

Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.

使用局限性：BREYANZI不适用于原发性中枢神经系统淋巴瘤患者的治疗。

Adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response.

患有复发或难治性慢性淋巴细胞白血病（CLL）或小淋巴细胞淋巴瘤（SLL）的成年患者，他们至少接受过2种治疗方案，包括布鲁顿酪氨酸激酶（BTK）抑制剂和B细胞淋巴瘤2（BCL-2）抑制剂。根据响应率和响应持续时间，该适应症在加速批准下获得批准。

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s)..

是否继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。。

Adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s)..

成人复发或难治性滤泡性淋巴瘤（FL）患者接受过2次或更多次全身治疗。根据响应率和响应持续时间，该适应症在加速批准下获得批准。是否继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。

Bristol Myers Squibb: Creating a Better Future for People with Cancer

百时美施贵宝：为癌症患者创造更美好的未来

Bristol Myers Squibb is inspired by a single vision—transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus.

百时美施贵宝的灵感来自于通过科学改变患者生活的单一愿景。该公司癌症研究的目标是提供药物，为每位患者提供更好、更健康的生活，并使治愈成为可能。百时美施贵宝（Bristol-Myers Squibb）的研究人员正在探索个性化医学的新前沿，并通过创新的数字平台，将数据转化为洞察，从而提高他们的关注度。

Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle..

对因果人类生物学的深刻理解、尖端能力和差异化研究平台使该公司能够从各个角度处理癌症。。

Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future..

癌症可以无情地影响患者生活的许多方面，百时美施贵宝致力于采取行动解决护理的各个方面，从诊断到生存。作为癌症治疗领域的领导者，百时美施贵宝正在努力让所有癌症患者拥有更好的未来。。

Learn more about the science behind cell therapy and ongoing research at Bristol Myers Squibb here.

了解更多有关细胞疗法背后的科学知识以及百时美施贵宝正在进行的研究。

About Bristol Myers Squibb

关于百时美施贵宝

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram..

百时美施贵宝是一家全球生物制药公司，其使命是发现、开发和提供创新药物，帮助患者战胜严重疾病。有关百时美施贵宝的更多信息，请访问BMS.com或在LinkedIn、Twitter、YouTube、Facebook和Instagram上关注我们。。