单次输注CARVYKTI®（西达基奥仑赛）在复发性或难治性多发性骨髓瘤患者中实现了至少五年的持久无治疗缓解-动脉网

Single infusion of CARVYKTI® (ciltacabtagene autoleucel) delivered lasting treatment-free remissions for at least five years in patients with relapsed or refractory multiple myeloma

强生等信源发布 2025-06-03 04:08

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可切换为仅中文

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New long-term CARTITUDE-1 data show one-third of patients treated with CARVYKTI

新的长期CARTITUDE-1数据显示，三分之一的患者接受了CARVYKTI治疗。

remain progression-free

保持无进展

CARTITUDE-4 analysis shows compelling overall survival and progression-free benefits in standard and high-risk subgroups across prior lines of treatment

CARTITUDE-4分析显示，在先前治疗的各亚组中，无论是标准风险还是高风险亚组，总体生存率和无进展生存期均有显著益处。

CHICAGO

芝加哥

，

June 3, 2025

2025年6月3日

/PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today new long-term follow-up data from the Phase 1b/2 CARTITUDE-1 study demonstrating 33 percent (n=32) of patients in the study (n=97) with relapsed or refractory multiple myeloma (RRMM) treated with CARVYKTI

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布了来自1b/2期CARTITUDE-1研究的新的长期随访数据，数据显示，在接受CARVYKTI治疗的复发或难治性多发性骨髓瘤（RRMM）患者中，有33%（n=32）的患者在研究中（n=97）。

(ciltacabtagene autoleucel; cilta-cel) achieved progression-free survival (PFS) of five years or more with a single infusion and no maintenance or subsequent anti-myeloma therapy.

（cilta-cel）单次输注后达到五年或更长时间的无进展生存期 (PFS)，且无需维持治疗或后续抗骨髓瘤治疗。

These data underscore Johnson & Johnson's dedication to advancing transformative therapies that aim to reshape the treatment landscape for patients with multiple myeloma.

这些数据强调了强生公司致力于推进旨在重塑多发性骨髓瘤患者治疗前景的变革性疗法。

In a subset of 12 patients who underwent serial evaluations at a single site, all were minimal residual disease (MRD) negative and imaging negative throughout five years of post-treatment follow-up. Findings were featured in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (.

在12名于单一地点接受连续评估的患者子集中，所有人在五年治疗后随访期间均达到最小残留病灶（MRD）阴性和影像学阴性。这些发现已在2025年美国临床肿瘤学会（ASCO）年会上以口头报告形式展示。

Abstract #7507

摘要 #7507

). The data were also simultaneously published in

）。数据也同时发布在

The Journal of Clinical Oncology

《临床肿瘤学杂志》

。

'This new evidence shows how a single infusion of CARVYKTI can help patients survive without disease progression much longer than previously thought possible in this setting, and without any maintenance or subsequent treatment,' said Peter M. Voorhees*, M.D., Clinical Professor of Hematology and Oncology at Atrium Health, Levine Cancer Institute at Wake Forest University School of Medicine.

“这项新的证据表明，在这种情况下，单次输注CARVYKTI可以帮助患者在没有疾病进展的情况下存活的时间比以前认为的要长得多，而且无需任何维持或后续治疗，”彼得·M. 沃尔希斯（Peter M. Voorhees）博士说道，他是Atrium Health、莱文癌症研究所（Wake Forest大学医学院）的血液学和肿瘤学临床教授。

'In a heavily pre-treated population, a third of patients remained treatment- and progression-free for at least five years.'.

“在经过大量预处理的人群中，三分之一的患者在至少五年内保持无治疗和无进展。”

The Phase 1b/2 CARTITUDE-1 study (n=97) evaluated CARVYKTI

1b/2期CARTITUDE-1研究（n=97）评估了CARVYKTI

for the treatment of heavily pre-treated patients with RRMM. Patients who remained progression free for at least five years (n=32) had a median of six prior lines of therapy and included subgroups with high-risk cytogenetics (23.3 percent), extramedullary disease (12.5 percent), triple-class refractory (90.6 percent), and penta-drug refractory (46.9 percent).

用于治疗经过多线治疗的RRMM患者。保持至少五年无疾病进展的患者（n=32）既往治疗中位数为六线，其中包括高危细胞遗传学（23.3%）、髓外病变（12.5%）、三类药物耐药（90.6%）和五药耐药（46.9%）的亚组患者。

At a median follow-up of 61.3 months, median overall survival (OS) was 60.7 months (95 percent confidence interval [CI] 41.9, not estimable [NE]), highlighting the depth and durability of response with CARVYKTI.

在中位随访61.3个月时，中位总生存期（OS）为60.7个月（95%置信区间[CI] 41.9，不可估量[NE]），突显了CARVYKTI治疗反应的深度和持久性。

。

With longer follow up, the safety profile in CARTITUDE-1 was consistent with the known safety profile of CARVYKTI

随着更长时间的随访，CARTITUDE-1中的安全性特征与CARVYKTI已知的安全性特征一致。

, with no new safety signals observed. There were two newly reported second primary malignancies (both solid tumors) and no new Parkinsonism events or cranial nerve palsies.

，未观察到新的安全信号。报告了两例新发的第二原发恶性肿瘤（均为实体瘤），没有新的帕金森综合征事件或颅神经麻痹。

Additional data from another CARVYKTI

来自另一个CARVYKTI的额外数据

study, CARTITUDE-4, presented at the 2025 ASCO Annual Meeting evaluated PFS and OS versus standard of care in prespecified subgroups, including patients with standard and high-risk cytogenetics, extramedullary disease and by line of therapy (

研究，CARTITUDE-4，在2025年ASCO年会上发布，评估了与标准治疗相比的无进展生存期（PFS）和总生存期（OS），包括标准和高危细胞遗传学、髓外疾病以及按治疗线划分的预设亚组。

Abstract #7539

摘要 #7539

). Results demonstrated that CARVYKTI

）。结果表明，CARVYKTI

improved PFS and OS across subgroups. In patients with standard-risk disease after one to three prior lines of treatment, PFS curves indicate stability in survival rates.

在各亚组中，PFS和OS均有所改善。对于经过一到三线治疗后病情属于标准风险的患者，PFS曲线表明生存率保持稳定。

'Across our multiple myeloma portfolio and pipeline, we are shifting from treating to progression to treating to cure,' said Jordan Schecter, M.D., Vice President, Research & Development, Multiple Myeloma, Johnson & Johnson Innovative Medicine. 'Our focus is to extend patient survival, and based on our expertise of the disease biology, develop treatment regimens with curative potential.'.

“在我们的多发性骨髓瘤产品组合和研发管线中，我们正在从治疗以延缓疾病进展转向治疗以实现治愈，”强生创新医学部多发性骨髓瘤研发副总裁Jordan Schecter博士表示。“我们的重点是延长患者的生存期，并基于我们对疾病生物学的专业知识，开发具有治愈潜力的治疗方案。”

Results will also be presented at the upcoming

结果还将在即将举行的会议上展示

European Hematology Association (EHA) 2025 Congress

欧洲血液学协会（EHA）2025年大会

。

About the CARTITUDE-1 Study

关于CARTITUDE-1研究

CARTITUDE-1 (

NCT03548207

) is a Phase 1b/2, open-label, multicenter study that evaluated the efficacy and safety of cilta-cel in adults with relapsed and/or refractory multiple myeloma (RRMM), 99 percent of whom were refractory to the last line of treatment; 88 percent of whom were triple-class refractory, meaning their cancer did not or no longer responds to an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody..

）是一项1b/2期、开放标签、多中心研究，评估了cilta-cel在复发和/或难治性多发性骨髓瘤（RRMM）成人患者中的疗效和安全性，其中99％的患者对上一次治疗产生耐药性；88％的患者为三类药物耐药，意味着他们的癌症对免疫调节剂、蛋白酶体抑制剂和抗CD38抗体无反应或不再有反应。

The primary objective of the Phase 1b portion of the study, involving 29 patients, was to characterize the safety and confirm the dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). Based on the safety profile observed in this portion of the study, outpatient dosing is being evaluated in additional CARTITUDE studies.

本研究的1b期部分涉及29名患者，其主要目的是描述cilta-cel的安全性并确认剂量，这是基于首次人体研究LCAR-B38M CAR-T细胞（LEGEND-2）得出的。根据本研究部分观察到的安全性特征，正在其他CARTITUDE研究中评估门诊给药。

The Phase 2 portion of the study is evaluating the efficacy of cilta-cel with overall response as the primary endpoint. The study involved patients with heavily pretreated RRMM who historically have an expected median progression-free survival of <6 months and median overall survival of ~1 year. .

该研究的第 2 阶段部分正在评估 cilta-cel 的疗效，主要终点为总体缓解率。研究涉及的是经过大量预处理的 RRMM 患者，这些患者的历史数据表明，预期中位无进展生存期小于 6 个月，中位总生存期约为 1 年。

About CARTITUDE-4

关于CARTITUDE-4

CARTITUDE-4 (

NCT04181827

) is the first randomized Phase 3 study evaluating the efficacy and safety of CARVYKTI

）是首个评估CARVYKTI疗效和安全性的随机3期研究

. The study compares CARVYKTI

该研究比较了CARVYKTI

with standard of care treatments PVd or DPd in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy. The primary endpoint of the study is progression-free survival (PFS); safety, OS, minimal residual disease negative rate and overall response rate are secondary endpoints. .

在接受过一至三线既往治疗的复发性和来那度胺难治性多发性骨髓瘤成年患者中，使用标准治疗方案PVd或DPd。研究的主要终点是无进展生存期（PFS）；安全性、总生存期（OS）、微小残留病阴性率和总体缓解率是次要终点。

About CARVYKTI

关于CARVYKTI

(ciltacabtagene autoleucel; cilta-cel)

（西尔塔卡巴基因自体白细胞；西尔塔-赛尔）

CARVYKTI

西达基奥仑赛

(cilta-cel) received U.S. Food and Drug Administration

(cilta-cel) 获得美国食品药品监督管理局审批

approval

批准

in February 2022 for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

2022年2月，用于治疗接受过四种或更多种前期治疗（包括蛋白酶体抑制剂、免疫调节剂和抗CD38单克隆抗体）后复发或难治性多发性骨髓瘤的成人患者。

In April 2024, CARVYKTI

2024年4月，CARVYKTI

was

是

approved as the first and only cell therapy

被批准为首个也是唯一的细胞疗法

in the U.S. for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and who are refractory to lenalidomide. In April 2024, the European Medicines Agency (EMA)

在美国，用于治疗接受过至少一种先前治疗方案（包括蛋白酶体抑制剂和免疫调节剂）并且对来那度胺耐药的复发或难治性多发性骨髓瘤成年患者。2024年4月，欧洲药品管理局（EMA）

approved

已批准

a Type II variation for CARVYKTI

CARVYKTI的II型变异

for the treatment of adults with relapsed and refractory multiple myeloma who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.

用于治疗接受过至少一种先前疗法（包括免疫调节剂和蛋白酶体抑制剂）的复发性和难治性多发性骨髓瘤成人患者，这些患者在最后一次治疗中已显示疾病进展，并且对来那度胺产生耐药性。

CARVYKTI

西达基奥仑赛

is a BCMA-directed, genetically modified autologous T-cell immunotherapy that involves reprogramming a patient's own T-cells with a transgene encoding chimeric antigen receptor (CAR) that directs the CAR-positive T cells to eliminate cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells.

是一种针对BCMA的基因修饰自体T细胞免疫疗法，涉及用编码嵌合抗原受体（CAR）的转基因重新编程患者自身的T细胞，使表达CAR的T细胞定向清除表达BCMA的细胞。BCMA主要表达于恶性多发性骨髓瘤B系细胞、晚期B细胞及浆细胞的表面。

The CARVYKTI.

西达基奥仑赛。

CAR protein features two BCMA-targeting single domains designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.

CAR蛋白具有两个靶向BCMA的单结构域，旨在对人BCMA产生高亲和力。在与表达BCMA的细胞结合后，CAR促进T细胞的激活、扩增并清除靶细胞。

In December 2017, Janssen Biotech, Inc., a Johnson & Johnson company, entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize CARVYKTI

2017年12月，强生公司旗下的杨森生物技术公司与传奇生物美国公司签订了独家全球许可和合作协议，以开发和商业化CARVYKTI。

。

For more information, visit

欲了解更多信息，请访问

www.CARVYKTI.com

。

About Multiple Myeloma

关于多发性骨髓瘤

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.

多发性骨髓瘤是一种无法治愈的血液癌症，它影响一种叫做浆细胞的白细胞，这些细胞存在于骨髓中。

In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.

在多发性骨髓瘤中，这些浆细胞迅速增殖和扩散，并在骨髓中取代正常细胞形成肿瘤。

Multiple myeloma is the third most common blood cancer worldwide and remains an incurable disease.

多发性骨髓瘤是全球第三常见的血液癌症，仍然是一种无法治愈的疾病。

In 2024, it was estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 people would die from the disease.

2024年，据估计在美国将有超过35,000人被诊断出患有多发性骨髓瘤，而且超过12,000人会死于该疾病。

People living with multiple myeloma have a 5-year survival rate of 59.8 percent.

多发性骨髓瘤患者的五年生存率为 59.8%。

While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.

虽然一些被诊断为多发性骨髓瘤的人最初没有症状，但大多数患者因包括骨折或疼痛、红细胞计数低、疲倦、高钙水平以及肾脏问题或感染等症状而被确诊。

9,10

CARVYKTI

西达基奥仑赛

IMPORTANT SAFETY INFORMATION

重要安全信息

INDICATIONS AND USAGE

适应症和用法

CARVYKTI

西达基奥仑赛

(ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. .

（西达基奥仑赛）是一种B细胞成熟抗原（BCMA）导向的基因修饰自体T细胞免疫疗法，适用于治疗复发或难治性多发性骨髓瘤成年患者，这些患者至少接受过一种前期治疗，包括蛋白酶体抑制剂和免疫调节剂，并且对来那度胺耐药。

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED and RECURRENT CYTOPENIA, and SECONDARY HEMATOLOGICAL MALIGNANCIES

警告：细胞因子释放综合征、神经毒性、HLH/MAS、持续性和复发性细胞减少症，以及继发性血液系统恶性肿瘤

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI

细胞因子释放综合征（CRS），包括致命或危及生命的反应，在患者接受CARVYKTI治疗后发生。

. Do not administer CARVYKTI

. 不要使用CARVYKTI

to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.

对于患有活动性感染或炎症性疾病的患者。使用托珠单抗或托珠单抗与皮质类固醇治疗严重或危及生命的CRS。

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI

免疫效应细胞相关神经毒性综合征 (ICANS)，可能致命或危及生命，在使用CARVYKTI治疗后发生。

, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with CARVYKTI

，包括在CRS发生前、与CRS同时、CRS消退后或在没有CRS的情况下。在使用CARVYKTI治疗后监测神经学事件。

. Provide supportive care and/or corticosteroids as needed.

根据需要提供支持性护理和/或皮质类固醇。

Parkinsonism and Guillain-Barré syndrome (GBS) and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI

帕金森综合征和吉兰-巴雷综合征 (GBS) 及其相关并发症在使用CARVYKTI治疗后出现，导致了致命或危及生命的反应。

。

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI

患者在接受CARVYKTI治疗后出现了噬血细胞性淋巴组织细胞增多症/巨噬细胞活化综合征（HLH/MAS），包括致命和危及生命的反应。

. HLH/MAS can occur with CRS or neurologic toxicities.

HLH/MAS可以与CRS或神经毒性同时发生。

Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI

接受CARVYKTI治疗后，出现长期和/或反复的血细胞减少，并伴有出血和感染，需要进行干细胞移植以恢复造血功能。

。

Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients following treatment with CARVYKTI

继发性血液系统恶性肿瘤，包括骨髓增生异常综合征和急性髓系白血病，曾在接受CARVYKTI治疗的患者中发生。

. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI

在接受BCMA和CD19导向的基因修饰自体T细胞免疫疗法（包括CARVYKTI）治疗血液恶性肿瘤后，发生了T细胞恶性肿瘤。

。

CARVYKTI

西达基奥仑赛

is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI

只能通过风险评估和缓解策略（REMS）下的受限计划获得，该计划被称为CARVYKTI。

REMS Program.

风险评估与缓解策略（REMS）计划。

WARNINGS AND PRECAUTIONS

警告与注意事项

Increased early mortality

早期死亡率增加

- In CARTITUDE-4, a (1:1) randomized controlled trial, there was a numerically higher percentage of early deaths in patients randomized to the CARVYKTI

在CARTITUDE-4这项（1:1）随机对照试验中，接受CARVYKTI治疗的患者中早期死亡的比例在数值上较高。

treatment arm compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208; 14%) occurred in the CARVYKTI

治疗组与对照组相比。在随机分组后前10个月内死亡的患者中，CARVYKTI组中发生了更高比例的死亡（29/208；14%）。

arm compared to (25/211; 12%) in the control arm. Of the 29 deaths that occurred in the CARVYKTI

试验组与对照组 (25/211；12%) 相比。在CARVYKTI组中发生的29例死亡中，

arm within the first 10 months of randomization, 10 deaths occurred prior to CARVYKTI

随机分组后的前10个月内，CARVYKTI之前发生了10例死亡。

infusion, and 19 deaths occurred after CARVYKTI

输注，之后发生19例死亡

infusion. Of the 10 deaths that occurred prior to CARVYKTI

输注。在CARVYKTI之前发生的10例死亡中

infusion, all occurred due to disease progression, and none occurred due to adverse events. Of the 19 deaths that occurred after CARVYKTI

输注，所有死亡均因疾病进展而发生，没有一例因不良事件导致。在CARVYKTI之后发生的19例死亡中，

infusion, 3 occurred due to disease progression, and 16 occurred due to adverse events. The most common adverse events were due to infection (n=12).

输液，3例因疾病进展发生，16例因不良事件发生。最常见的不良事件是感染（n=12）。

Cytokine release syndrome (CRS),

细胞因子释放综合征 (CRS)，

including fatal or life-threatening reactions, occurred following treatment with CARVYKTI

包括致命或危及生命的反应，在接受CARVYKTI治疗后发生。

. Among patients receiving CARVYKTI

在接受CARVYKTI治疗的患者中

for RRMM in the CARTITUDE-1 & 4 studies (N=285), CRS occurred in 84% (238/285), including ≥Grade 3 CRS (ASCT 2019) in 4% (11/285) of patients. Median time to onset of CRS, any grade, was 7 days (range: 1 to 23 days). CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (≥10%) included fever (84%), hypotension (29%) and aspartate aminotransferase increased (11%).

在CARTITUDE-1和4研究中（N=285），84%（238/285）的RRMM患者出现细胞因子释放综合征（CRS），其中≥3级CRS（ASCT 2019）发生在4%（11/285）的患者中。任何等级CRS的中位发生时间为7天（范围：1至23天）。82%的患者CRS得到缓解，中位持续时间为4天（范围：1至97天）。所有患者中CRS最常见的表现（≥10%）包括发热（84%）、低血压（29%）和天门冬氨酸氨基转移酶升高（11%）。

Serious events that may be associated with CRS include pyrexia, hemophagocytic lymphohistiocytosis, respiratory failure, disseminated intravascular coagulation, capillary leak syndrome, and supraventricular and ventricular tachycardia. CRS occurred in 78% of patients in CARTITUDE-4 (3% Grade 3 to 4) and in 95% of patients in CARTITUDE-1 (4% Grade 3 to 4). .

可能与CRS相关的严重事件包括发热、噬血细胞性淋巴组织细胞增生症、呼吸衰竭、弥散性血管内凝血、毛细血管渗漏综合征以及室上性和室性心动过速。在CARTITUDE-4研究中，78%的患者出现CRS（3%为3至4级），而在CARTITUDE-1研究中，95%的患者出现CRS（4%为3至4级）。

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS. .

根据临床表现识别CRS。评估并治疗发热、低氧和低血压的其他原因。据报道，CRS与HLH/MAS的发现有关，这些综合征的病理生理可能重叠。HLH/MAS是一种可能危及生命的状况。在CRS症状进展或治疗后仍然难治的患者中，应评估HLH/MAS的证据。

Ensure that a minimum of two doses of tocilizumab are available prior to infusion of CARVYKTI

在输注CARVYKTI之前，确保至少有两剂托珠单抗可用。

。

Of the 285 patients who received CARVYKTI

在接受CARVYKTI治疗的285名患者中

in clinical trials, 53% (150/285) patients received tocilizumab; 35% (100/285) received a single dose, while 18% (50/285) received more than 1 dose of tocilizumab. Overall, 14% (39/285) of patients received at least one dose of corticosteroids for treatment of CRS.

在临床试验中，53%（150/285）的患者接受了托珠单抗治疗；35%（100/285）的患者接受单剂量治疗，而18%（50/285）的患者接受了多于一剂的托珠单抗。总体而言，14%（39/285）的患者至少接受了一剂皮质类固醇用于治疗CRS。

Monitor patients at least daily for 10 days following CARVYKTI

在使用CARVYKTI后的10天内，至少每天监测患者一次。

infusion at a REMS-certified healthcare facility for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 4 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids.

在经REMS认证的医疗机构进行输注，以观察CRS的体征和症状。在输注后至少4周内监测患者的CRS体征或症状。一旦出现CRS的首个症状，立即开始使用支持性护理、托珠单抗或托珠单抗与皮质类固醇进行治疗。

Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

如果出现CRS的任何体征或症状，应建议患者立即寻求医疗关注。

Neurologic toxicities,

神经毒性，

which may be severe, life-threatening, or fatal, occurred following treatment with CARVYKTI

可能严重、危及生命或致命，在使用CARVYKTI治疗后发生。

. Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of parkinsonism, GBS, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities.

神经毒性包括ICANS、伴有帕金森症状的神经毒性、GBS、免疫介导的脊髓炎、周围神经病变和颅神经麻痹。告知患者这些神经毒性的症状和体征，以及某些毒性发作的延迟性。

Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time. .

如果在任何时候出现任何这些神经毒性的体征或症状，应指导患者立即寻求医疗救助以进行进一步的评估和处理。

Among patients receiving CARVYKTI

接受CARVYKTI治疗的患者中

in the CARTITUDE-1 & 4 studies for RRMM, one or more neurologic toxicities occurred in 24% (69/285), including ≥Grade 3 cases in 7% (19/285) of patients. Median time to onset was 10 days (range: 1 to 101) with 63/69 (91%) of cases developing by 30 days. Neurologic toxicities resolved in 72% (50/69) of patients with a median duration to resolution of 23 days (range: 1 to 544).

在CARTITUDE-1和4研究中，针对RRMM患者，24%（69/285）的患者出现了一种或多种神经毒性，其中7%（19/285）的患者为≥3级病例。神经毒性的中位发病时间为10天（范围：1至101），69例中有63例（91%）在30天内发生。72%（50/69）的患者的神经毒性得到缓解，缓解的中位持续时间为23天（范围：1至544）。

Of patients developing neurotoxicity, 96% (66/69) also developed CRS. Subtypes of neurologic toxicities included ICANS in 13%, peripheral neuropathy in 7%, cranial nerve palsy in 7%, parkinsonism in 3%, and immune mediated myelitis in 0.4% of the patients. .

在出现神经毒性的患者中，96%（66/69）同时出现了CRS。神经毒性亚型包括13%的患者出现ICANS，7%出现周围神经病变，7%出现颅神经麻痹，3%出现帕金森综合征，0.4%出现免疫介导的脊髓炎。

Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS):

免疫效应细胞相关神经毒性综合征 (ICANS):

Patients receiving CARVYKTI

接受CARVYKTI治疗的患者

may experience fatal or life-threatening ICANS following treatment with CARVYKTI

可能在使用CARVYKTI治疗后出现致命或危及生命的ICANS

, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS.

，包括在CRS发作之前、与CRS同时、CRS缓解之后，或在没有CRS的情况下。

Among patients receiving CARVYKTI

在接受CARVYKTI治疗的患者中

in the CARTITUDE-1 & 4 studies, ICANS occurred in 13% (36/285), including Grade ≥3 in 2% (6/285) of the patients. Median time to onset of ICANS was 8 days (range: 1 to 28 days). ICANS resolved in 30 of 36 (83%) of patients with a median time to resolution of 3 days (range: 1 to 143 days). Median duration of ICANS was 6 days (range: 1 to 1229 days) in all patients including those with ongoing neurologic events at the time of death or data cut off.

在CARTITUDE-1和4研究中，13%（36/285）的患者发生了ICANS，其中2%（6/285）为3级或以上。ICANS的中位发病时间为8天（范围：1至28天）。在36例患者中，有30例（83%）ICANS得到缓解，缓解的中位时间为3天（范围：1至143天）。所有患者（包括在死亡或数据截止时仍有持续神经事件的患者）中，ICANS的中位持续时间为6天（范围：1至1229天）。

Of patients with ICANS 97% (35/36) had CRS. The onset of ICANS occurred during CRS in 69% of patients, before and after the onset of CRS in 14% of patients respectively. .

在患有ICANS的患者中，97%（35/36）出现了CRS。69%的患者ICANS发作发生在CRS期间，分别有14%的患者在CRS发作之前和之后出现ICANS。

Immune Effector Cell-associated Neurotoxicity Syndrome occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3) and in 23% of patients in CARTITUDE-1 (3% Grade 3). The most frequent ≥2% manifestations of ICANS included encephalopathy (12%), aphasia (4%), headache (3%), motor dysfunction (3%), ataxia (2%) and sleep disorder (2%). .

在CARTITUDE-4研究中，7%的患者（0.5%为3级）出现了免疫效应细胞相关神经毒性综合征，在CARTITUDE-1研究中，23%的患者（3%为3级）出现该症状。ICANS最常见的≥2%表现包括脑病（12%）、失语症（4%）、头痛（3%）、运动功能障碍（3%）、共济失调（2%）和睡眠障碍（2%）。

Monitor patients at least daily for 10 days following CARVYKTI

在使用CARVYKTI后的10天内，至少每天监测患者一次。

infusion at the REMS-certified healthcare facility for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms. Monitor patients for signs or symptoms of ICANS for at least 4 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. .

在REMS认证的医疗机构进行输注，以监测ICANS的体征和症状。排除ICANS症状的其他原因。在输注后至少4周内监测患者的ICANS体征或症状，并及时治疗。应根据需要通过支持性护理和/或皮质类固醇来管理神经毒性。

Parkinsonism:

帕金森综合征：

Neurologic toxicity with parkinsonism has been reported in clinical trials of CARVYKTI

临床试验中已报告CARVYKTI出现伴有帕金森病症状的神经毒性。

. Among patients receiving CARVYKTI

在接受CARVYKTI治疗的患者中

in the CARTITUDE-1 & 4 studies, parkinsonism occurred in 3% (8/285), including Grade ≥ 3 in 2% (5/285) of the patients. Median time to onset of parkinsonism was 56 days (range: 14 to 914 days). Parkinsonism resolved in 1 of 8 (13%) of patients with a median time to resolution of 523 days. Median duration of parkinsonism was 243.5 days (range: 62 to 720 days) in all patients including those with ongoing neurologic events at the time of death or data cut off.

在CARTITUDE-1和4研究中，3%（8/285）的患者出现帕金森综合征，其中2%（5/285）为3级或以上。帕金森综合征的中位发病时间为56天（范围：14至914天）。在8名患者中有1名（13%）帕金森综合征得到缓解，缓解的中位时间为523天。所有患者中，包括那些在死亡时或数据截止时仍有持续神经事件的患者，帕金森综合征的中位持续时间为243.5天（范围：62至720天）。

The onset of parkinsonism occurred after CRS for all patients and after ICANS for 6 patients. .

所有患者在CRS后出现帕金森症状，其中6名患者在ICANS后出现。

Parkinsonism occurred in 1% of patients in CARTITUDE-4 (no Grade 3 to 4) and in 6% of patients in CARTITUDE-1 (4% Grade 3 to 4).

帕金森综合征在CARTITUDE-4试验中发生率为1%（无3至4级），在CARTITUDE-1试验中发生率为6%（4%为3至4级）。

Manifestations of parkinsonism included movement disorders, cognitive impairment, and personality changes. Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson's disease for the improvement or resolution of parkinsonism symptoms following CARVYKTI.

帕金森综合征的表现包括运动障碍、认知障碍和人格改变。监测患者帕金森综合征可能延迟出现的体征和症状，并通过支持性护理措施进行管理。对于使用CARVYKTI治疗后出现的帕金森综合征症状的改善或消退，目前用于治疗帕金森病的药物疗效信息有限。

treatment.

治疗。

Guillain-Barré syndrome:

吉兰-巴雷综合征：

A fatal outcome following GBS occurred following treatment with CARVYKTI

GBS 治疗后使用 CARVYKTI 出现了致命结果。

despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances, and polyradiculoneuritis.

尽管使用了静脉注射免疫球蛋白治疗，但报告的症状包括与米勒-费舍尔变异型GBS、脑病、运动无力、言语障碍和多发性神经根炎相符的症状。

Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS.

监测GBS。评估出现周围神经病变的患者是否患有GBS。根据GBS的严重程度，考虑通过支持性护理措施以及结合免疫球蛋白和血浆置换来治疗GBS。

Immune mediated myelitis:

免疫介导的脊髓炎:

Grade 3 myelitis occurred 25 days following treatment with CARVYKTI

在使用CARVYKTI治疗后25天发生了3级脊髓炎

in CARTITUDE-4 in a patient who received CARVYKTI

在CARTITUDE-4研究中，一名接受CARVYKTI治疗的患者

as subsequent therapy. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause.

作为后续治疗。报告的症状包括下肢和下腹部感觉减退，并伴有括约肌控制受损。使用皮质类固醇和静脉注射免疫球蛋白后症状有所改善。在因其他原因死亡时，脊髓炎仍在持续。

Peripheral neuropathy

周围神经病变

occurred following treatment with CARVYKTI

发生在接受CARVYKTI治疗后

. Among patients receiving CARVYKTI

在接受CARVYKTI治疗的患者中

in the CARTITUDE-1 & 4 studies, peripheral neuropathy occurred in 7% (21/285), including Grade ≥3 in 1% (3/285) of the patients. Median time to onset of peripheral neuropathy was 57 days (range: 1 to 914 days). Peripheral neuropathy resolved in 11 of 21 (52%) of patients with a median time to resolution of 58 days (range: 1 to 215 days).

在CARTITUDE-1和4研究中，7%（21/285）的患者发生了周围神经病变，其中1%（3/285）为3级或以上。周围神经病变发生的中位时间为57天（范围：1至914天）。在21名患者中有11名（52%）周围神经病变得到解决，解决的中位时间为58天（范围：1至215天）。

Median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients including those with ongoing neurologic events at the time of death or data cut off. .

所有患者中，包括那些在死亡或数据截止时仍有持续神经病变的患者，外周神经病变的中位持续时间为149.5天（范围：1至692天）。

Peripheral neuropathies occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3 to 4) and in 7% of patients in CARTITUDE-1 (2% Grade 3 to 4). Monitor patients for signs and symptoms of peripheral neuropathies. Patients who experience peripheral neuropathy may also experience cranial nerve palsies or GBS. .

CARTITUDE-4研究中7%的患者（0.5%为3至4级）和CARTITUDE-1研究中7%的患者（2%为3至4级）发生了周围神经病变。监测患者周围神经病变的症状和体征。经历周围神经病变的患者也可能出现颅神经麻痹或GBS。

Cranial nerve palsies

颅神经麻痹

occurred following treatment with CARVYKTI

在使用CARVYKTI治疗后发生

. Among patients receiving CARVYKTI

在接受CARVYKTI治疗的患者中

in the CARTITUDE-1 & 4 studies, cranial nerve palsies occurred in 7% (19/285), including Grade ≥3 in 1% (1/285) of the patients. Median time to onset of cranial nerve palsies was 21 days (range: 17 to 101 days). Cranial nerve palsies resolved in 17 of 19 (89%) of patients with a median time to resolution of 66 days (range: 1 to 209 days).

在CARTITUDE-1和4研究中，7%（19/285）的患者发生了颅神经麻痹，其中1%（1/285）为3级或以上。颅神经麻痹发生的中位时间为21天（范围：17至101天）。19名患者中有17名（89%）颅神经麻痹得到缓解，缓解的中位时间为66天（范围：1至209天）。

Median duration of cranial nerve palsies was 70 days (range: 1 to 262 days) in all patients including those with ongoing neurologic events at the time of death or data cut off. Cranial nerve palsies occurred in 9% of patients in CARTITUDE-4 (1% Grade 3 to 4) and in 3% of patients in CARTITUDE-1 (1% Grade 3 to 4). .

所有患者中，包括那些在死亡时或数据截止时仍有持续神经事件的患者，颅神经麻痹的中位持续时间为70天（范围：1至262天）。在CARTITUDE-4研究中，9%的患者出现颅神经麻痹（1%为3至4级），而在CARTITUDE-1研究中，3%的患者出现颅神经麻痹（1%为3至4级）。

The most frequent cranial nerve affected was the 7th cranial nerve. Additionally, cranial nerves III, V, and VI have been reported to be affected.

受影响最频繁的颅神经是第七对颅神经。此外，有报告称第三、第五和第六对颅神经也受到影响。

Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms.

监测患者是否有颅神经麻痹的体征和症状。根据体征和症状的严重程度及进展情况，考虑使用全身性皮质类固醇进行管理。

Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS):

噬血细胞性淋巴组织细胞增多症 (HLH)/巨噬细胞活化综合征 (MAS):

Among patients receiving CARVYKTI

在接受CARVYKTI治疗的患者中

in the CARTITUDE-1 & 4 studies, HLH/MAS occurred in 1% (3/285) of patients. All events of HLH/MAS had onset within 99 days of receiving CARVYKTI

在CARTITUDE-1和4研究中，1%（3/285）的患者发生了HLH/MAS。所有HLH/MAS事件均在使用CARVYKTI后99天内发生。

, with a median onset of 10 days (range: 8 to 99 days) and all occurred in the setting of ongoing or worsening CRS. The manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia and multi-organ dysfunction, including renal dysfunction and respiratory failure. .

中位发病时间为10天（范围：8至99天），所有病例均发生在持续或恶化的CRS背景下。HLH/MAS的表现包括高铁蛋白血症、低血压、伴弥漫性肺泡损伤的低氧血症、凝血功能障碍和出血、细胞减少以及多器官功能障碍，包括肾功能障碍和呼吸衰竭。

Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematologic parameters in patients with HLH/MAS and transfuse per institutional guidelines. Fatal cases of HLH/MAS occurred following treatment with CARVYKTI

发展为HLH/MAS的患者有较高的严重出血风险。监测HLH/MAS患者的血液学参数，并按照机构指南进行输血。在使用CARVYKTI治疗后发生了致命的HLH/MAS病例。

。

HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards.

HLH是一种危及生命的疾病，如果不能早期识别和治疗，死亡率很高。HLH/MAS的治疗应按照机构标准进行。

CARVYKTI

西达基奥仑赛

REMS:

风险评估与缓解策略：

Because of the risk of CRS and neurologic toxicities, CARVYKTI

由于CRS和神经毒性风险，CARVYKTI

is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI

仅通过风险评估和缓解策略（REMS）下的一个受限项目提供，该项目称为CARVYKTI。

REMS.

风险评估与缓解策略 (REMS)。

Further information is available at

更多信息可访问

https://www.carvyktirems.com/

or 1-844-672-0067.

或 1-844-672-0067。

Prolonged and Recurrent Cytopenias:

长期和复发性细胞减少症：

Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI

患者在接受淋巴细胞清除化疗和CARVYKTI后可能会出现长期和反复的血细胞减少症。

infusion.

注入。

Among patients receiving CARVYKTI

在接受CARVYKTI治疗的患者中

in the CARTITUDE-1 & 4 studies, Grade 3 or higher cytopenias not resolved by day 30 following CARVYKTI

在CARTITUDE-1和4研究中，CARVYKTI给药后30天内未恢复的3级或更高级别的细胞减少症

infusion occurred in 62% (176/285) of the patients and included thrombocytopenia 33% (94/285), neutropenia 27% (76/285), lymphopenia 24% (67/285) and anemia 2% (6/285). After Day 60 following CARVYKTI

在62%（176/285）的患者中发生了细胞因子释放综合征，其中包括33%（94/285）的血小板减少症、27%（76/285）的中性粒细胞减少症、24%（67/285）的淋巴细胞减少症和2%（6/285）的贫血。在CARVYKTI输注后第60天。

infusion 22%, 20%, 5%, and 6% of patients had a recurrence of Grade 3 or 4 lymphopenia, neutropenia, thrombocytopenia, and anemia respectively, after initial recovery of their Grade 3 or 4 cytopenia. Seventy-seven percent (219/285) of patients had one, two or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia.

在初始恢复3级或4级细胞减少症后，分别有22%、20%、5%和6%的患者再次出现3级或4级淋巴细胞减少症、中性粒细胞减少症、血小板减少症和贫血。77%（219/285）的患者在初始恢复3级或4级细胞减少症后，出现一次、两次或三次及以上的3级或4级细胞减少症复发。

Sixteen and 25 patients had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, at the time of death. .

死亡时，分别有16名和25名患者出现3级或4级中性粒细胞减少和血小板减少。

Monitor blood counts prior to and after CARVYKTI

在使用CARVYKTI之前和之后监测血细胞计数

infusion. Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines.

输注。根据当地机构指南，使用生长因子和血液制品输注支持来管理细胞减少症。

Infections:

感染：

CARVYKTI

西达基奥仑赛

should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections, occurred in patients after CARVYKTI

不应给予患有活动性感染或炎症性疾病的患者。在使用CARVYKTI后，患者出现了严重、危及生命或致命的感染。

infusion.

注入。

Among patients receiving CARVYKTI

接受CARVYKTI治疗的患者中

in the CARTITUDE-1 & 4 studies, infections occurred in 57% (163/285), including ≥Grade 3 in 24% (69/285) of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients. Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19.

在CARTITUDE-1和4研究中，57%（163/285）的患者发生了感染，其中24%（69/285）为≥3级感染。12%的患者发生了病原未明确的3级或4级感染，6%为病毒感染，5%为细菌感染，1%为真菌感染。总体而言，5%（13/285）的患者发生了5级感染，其中2.5%是由COVID-19引起的。

Patients treated with CARVYKTI.

接受CARVYKTI治疗的患者。

had an increased rate of fatal COVID-19 infections compared to the standard therapy arm.

与标准治疗组相比，致命性新冠肺炎感染率升高。

Monitor patients for signs and symptoms of infection before and after CARVYKTI

在使用CARVYKTI之前和之后，监测患者是否出现感染的体征和症状。

infusion and treat patients appropriately. Administer prophylactic, pre-emptive and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI

输注并适当治疗患者。根据标准的机构指南给予预防性、抢先性或治疗性抗菌药物。在CARVYKTI输注后，5%的患者观察到发热性中性粒细胞减少症。

infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19. .

输注期间可能与CRS同时发生。如果出现发热性中性粒细胞减少症，应评估感染情况，并根据医学指征使用广谱抗生素、液体和其他支持性治疗进行管理。向患者强调预防措施的重要性。遵循机构针对免疫功能低下且感染COVID-19患者的疫苗接种和管理指南。

Viral Reactivation:

病毒再激活：

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing.

乙型肝炎病毒 (HBV) 再激活在某些情况下可能导致暴发性肝炎、肝功能衰竭和死亡，可能发生在低丙种球蛋白血症患者中。如果根据临床指南有临床指征，应在收集用于制造的细胞之前，对巨细胞病毒 (CMV)、乙型肝炎病毒 (HBV)、丙型肝炎病毒 (HCV)、人类免疫缺陷病毒 (HIV) 或任何其他病原体进行筛查。

Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice. .

根据当地机构指南/临床实践，考虑抗病毒治疗以防止病毒重新激活。

Hypogammaglobulinemia:

低丙种球蛋白血症:

can occur in patients receiving treatment with CARVYKTI

可能发生在接受CARVYKTI治疗的患者中

. Among patients receiving CARVYKTI

在接受CARVYKTI治疗的患者中

in the CARTITUDE-1 & 4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500mg/dl after infusion in 93% (265/285) of patients. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500mg/dl, after infusion occurred in 94% (267/285) of patients treated.

在CARTITUDE-1和4研究中，低丙种球蛋白血症不良事件在36%（102/285）的患者中被报告；输注后实验室IgG水平在93%（265/285）的患者中降至500mg/dl以下。输注后，无论是作为不良反应还是实验室IgG水平低于500mg/dl，低丙种球蛋白血症在94%（267/285）的治疗患者中发生。

Fifty six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI.

56% (161/285) 的患者在使用 CARVYKTI 后接受了静脉注射免疫球蛋白 (IVIG)。

for either an adverse reaction or prophylaxis.

用于不良反应或预防。

Monitor immunoglobulin levels after treatment with CARVYKTI

治疗后监测CARVYKTI的免疫球蛋白水平

and administer IVIG for IgG <400 mg/dL. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

对于IgG<400 mg/dL的患者，给予静脉注射免疫球蛋白（IVIG）。根据当地机构指南进行管理，包括感染预防措施以及抗生素或抗病毒预防。

Use of Live Vaccines:

活疫苗的使用：

The safety of immunization with live viral vaccines during or following CARVYKTI

在使用CARVYKTI期间或之后接种活病毒疫苗的安全性

treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI

治疗尚未被研究。在淋巴细胞清除化疗开始前至少6周内，以及CARVYKTI治疗期间，不建议接种活病毒疫苗。

treatment, and until immune recovery following treatment with CARVYKTI

治疗，以及直到使用CARVYKTI治疗后的免疫恢复

。

Hypersensitivity Reactions

超敏反应

occurred following treatment with CARVYKTI

发生在使用CARVYKTI治疗后

. Among patients receiving CARVYKTI

在接受CARVYKTI治疗的患者中

in the CARTITUDE-1 & 4 studies, hypersensitivity reactions occurred in 5% (13/285), all of which were ≤Grade 2. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, non-cardiac chest pain, and pyrexia.

在CARTITUDE-1和4研究中，5%（13/285）的患者发生了超敏反应，所有反应均为≤2级。超敏反应的表现包括潮红、胸部不适、心动过速、喘息、震颤、灼烧感、非心源性胸痛和发热。

Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) in CARVYKTI

严重的超敏反应，包括过敏反应，可能是由于CARVYKTI中的二甲基亚砜（DMSO）引起的。

. Patients should be carefully monitored for 2 hours after infusion for signs and symptoms of severe reaction. Treat promptly and manage patients appropriately according to the severity of the hypersensitivity reaction.

患者在输注后应仔细监测2小时，以观察是否出现严重反应的迹象和症状。根据超敏反应的严重程度，及时治疗并妥善管理患者。

Secondary Malignancies:

次要恶性肿瘤：

Patients treated with CARVYKTI

接受CARVYKTI治疗的患者

may develop secondary malignancies. Among patients receiving CARVYKTI

可能会发展为继发性恶性肿瘤。在接受CARVYKTI治疗的患者中

in the CARTITUDE-1 & 4 studies, myeloid neoplasms occurred in 5% (13/285) of patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia). The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with CARVYKTI.

在CARTITUDE-1和4研究中，5%（13/285）的患者出现髓系肿瘤（9例骨髓增生异常综合征，3例急性髓系白血病，1例骨髓增生异常综合征后转为急性髓系白血病）。髓系肿瘤发生的中位时间为使用CARVYKTI治疗后447天（范围：56至870天）。

. Ten of these 13 patients died following the development of myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported in the post marketing setting. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI.

在这13名患者中，有10名在髓系肿瘤发展后死亡；13例髓系肿瘤中有2例发生在后续抗骨髓瘤治疗开始之后。在上市后监测中也有报告骨髓增生异常综合征和急性髓系白血病的病例。在接受BCMA和CD19导向的基因修饰自体T细胞免疫疗法（包括CARVYKTI）治疗血液系统恶性肿瘤后，也发生了T细胞恶性肿瘤。

. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusions, and may include fatal outcomes.

成熟的T细胞恶性肿瘤，包括CAR阳性的肿瘤，可能在输注后的数周内出现，并且可能包括致命的结果。

Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Janssen Biotech, Inc. at

终身监测继发性恶性肿瘤。如果发生继发性恶性肿瘤，请联系杨森生物技术公司，地址是

1-800-526-7736

for reporting and to obtain instructions on collection of patient samples.

用于报告和获取患者样本收集的指示。

Effects on Ability to Drive and Use Machines:

对驾驶和使用机器能力的影响：

Due to the potential for neurologic events, including altered mental status, seizures, neurocognitive decline or neuropathy, patients receiving CARVYKTI

由于可能发生神经系统事件，包括精神状态改变、癫痫发作、神经认知衰退或神经病变，接受CARVYKTI治疗的患者

are at risk for altered or decreased consciousness or coordination in the 8 weeks following CARVYKTI

在接种CARVYKTI后的8周内，可能会出现意识或协调能力改变或下降的风险。

infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery during this initial period, and in the event of new onset of any neurologic toxicities.

输液。建议患者在此初始阶段避免驾驶和从事危险职业或活动，如操作重型或潜在危险机械，以及在出现任何新的神经毒性时。

ADVERSE REACTIONS

不良反应

The most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.

最常见的非实验室不良反应（发生率超过20%）包括发热、细胞因子释放综合征、低丙种球蛋白血症、低血压、肌肉骨骼疼痛、疲劳、感染（病原体未明确）、咳嗽、寒战、腹泻、恶心、脑病、食欲减退、上呼吸道感染、头痛、心动过速、头晕、呼吸困难、水肿、病毒感染、凝血功能障碍、便秘和呕吐。

The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia. .

最常见的 3 或 4 级实验室不良反应（发生率大于或等于 50%）包括淋巴细胞减少症、中性粒细胞减少症、白细胞减少、血小板减少症和贫血。

Please read full

请阅读全文

Prescribing Information

处方信息

, including Boxed Warning, for CARVYKTI

，包括CARVYKTI的加框警告，

。

About Johnson & Johnson

关于约翰逊 & 约翰逊

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

在强生，我们相信健康就是一切。我们在医疗保健创新方面的优势使我们能够构建一个世界，在这个世界中，复杂疾病得以预防、治疗和治愈，治疗方法更加智能且侵入性更小，解决方案也更加个性化。凭借我们在创新药物和医疗技术方面的专业知识，我们有能力在当今全面创新各类医疗保健解决方案，提供明日的突破性成果，并对人类健康产生深远影响。

Learn more at .

了解更多，请访问。

https://www.jnj.com/

or at

或在

https://www.innovativemedicine.jnj.com.

关注我们

@JanssenUS

and

和

@JNJInnovMed

. Janssen Research & Development, LLC, Janssen Biotech, Inc., and Janssen Global Services, LLC are Johnson & Johnson companies.

杨森研发有限责任公司、杨森生物科技公司和杨森全球服务有限责任公司均为强生公司旗下企业。

Cautions Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of

本新闻稿包含《1995年私人证券诉讼改革法案》中定义的“前瞻性声明”，涉及产品开发以及潜在益处和治疗影响。

CARVYKTI

西达基奥仑赛

(ciltacabtagene autoleucel; cilta-cel)

（西达基奥仑赛；cilta-cel）

. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson.

读者被提醒不要依赖这些前瞻性声明。这些声明基于对未来事件的当前预期。如果基本假设被证明不准确，或已知或未知的风险或不确定性成为现实，实际结果可能与强生公司的预期和预测大相径庭。

Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment.

风险和不确定性包括但不限于：产品研究和开发中固有的挑战和不确定性，包括临床成功的不确定性和获得监管批准的不确定性；商业成功的不确定性；生产困难和延误；竞争，包括技术进步、竞争对手推出的新产品和获得的专利；专利挑战；产品功效或安全问题导致的产品召回或监管行动；医疗保健产品和服务购买者的行为和支出模式的变化；适用法律法规的变更，包括全球医疗保健改革；以及控制医疗成本的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.

这些风险、不确定性和其他因素的进一步列表和描述，请参见强生公司最近的年度报告 Form 10-K，包括标题为“关于前瞻性陈述的警示声明”和“项目1A. 风险因素”的部分，以及强生公司随后的季度报告 Form 10-Q 和其他提交给证券交易委员会的文件。

Copies of these filings are available online at .

这些文件的副本可在线获取。

www.sec.gov

，

www.jnj.com

or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

或应Johnson & Johnson的要求。Johnson & Johnson不承担因新信息或未来事件或发展而更新任何前瞻性声明的义务。

Footnotes:

脚注：

Peter M. Voorhees, M.D., Clinical Professor of Hematology and Oncology at Atrium Health, Levine Cancer Institute at Wake Forest University School of Medicine, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

彼得·M·沃赫斯，医学博士，艾特里姆健康中心血液学和肿瘤学临床教授，威克森林大学医学院莱文癌症研究所，曾为强生公司提供咨询、顾问和演讲服务；他未因任何媒体工作获得报酬。

Voorhees PM. Long-term (≥5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM).

Voorhees PM. 在CARTITUDE-1试验中，使用西达基奥仑赛（cilta-cel）治疗复发/难治性多发性骨髓瘤（RRMM）患者的长期（≥5年）缓解与生存情况。

http://meetings.asco.org/2025-asco-annual-meeting/16380?presentation=246413%23246413

http://meetings.asco.org/2025-asco-年度会议/16380?presentation=246413%23246413

. Accessed May 2025.

访问时间：2025年5月。

Usmani S. Phase 1b/2 study of ciltacabtagene autoleucel, a BCMA-directed CAR-T cell therapy, in patients with relapsed/refractory multiple myeloma (CARTITUDE-1): Two years post-LPI. Abstract #8028 [Poster]. Presented at the 2022 American Society of Clinical Oncology Annual Meeting.

乌斯马尼 S. 一项关于ciltacabtagene autoleucel（一种针对BCMA的CAR-T细胞疗法）在复发/难治性多发性骨髓瘤患者中的1b/2期研究（CARTITUDE-1）：LPI后两年。摘要#8028 [海报]。在2022年美国临床肿瘤学会年会上发表。

CARVYKTI

西达基奥仑赛

U.S. Prescribing Information.

美国处方信息。

Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management.

拉吉库马尔 SV。多发性骨髓瘤：2020年关于诊断、风险分层和管理的更新。

Am J Hematol

美国血液学杂志

. 2020;95(5):548-5672020;95(5):548-567.

http://www.ncbi.nlm.nih.gov/pubmed/32212178

National Cancer Institute. Plasma Cell Neoplasms.

国家癌症研究所。浆细胞肿瘤。

https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq

. Accessed May 2025.

. 2025年5月访问。

City of Hope. Multiple Myeloma: Causes, Symptoms & Treatments.

希望之城。多发性骨髓瘤：原因、症状与治疗。

https://www.cancercenter.com/cancer-types/multiple-myeloma

. Accessed May 2025.

访问时间：2025年5月。

American Cancer Society. Key Statistics About Multiple Myeloma. https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=Multiple%20myeloma%20is%20a%20relatively,men%20and%2015%2C370%20in%20women. Accessed May 2025.

美国癌症协会。多发性骨髓瘤的关键统计数据。https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=Multiple%20myeloma%20is%20a%20relatively,men%20and%2015%2C370%20in%20women。访问时间：2025年5月。

SEER Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute.

SEER Explorer：SEER癌症统计的互动网站 [互联网]。监测研究计划，国家癌症研究所。

https://seer.cancer.gov/explorer/

. Accessed May 2025.

。访问时间：2025年5月。

American Cancer Society. What is Multiple Myeloma?

美国癌症协会。什么是多发性骨髓瘤？

https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html

. Accessed May 2025.

访问日期：2025年5月。

American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging

美国癌症协会。多发性骨髓瘤的早期检测、诊断和分期

https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html

. Accessed May 2025.

访问于2025年5月。

Media contact:

媒体联系人：

Oncology Media Relations

肿瘤学媒体关系

Oncology_media_relations@its.jnj.com

肿瘤学媒体关系@its.jnj.com

Investor contact:

投资者联系方式：

Lauren Johnson

劳伦·约翰逊

investor-relations@its.jnj.com

投资者关系@its.jnj.com

U.S. medical inquiries:

美国医学咨询：

+1 800 526-7736

View original content to download multimedia:

查看原始内容以下载多媒体：

https://www.prnewswire.com/news-releases/single-infusion-of-carvykti-ciltacabtagene-autoleucel-delivered-lasting-treatment-free-remissions-for-at-least-five-years-in-patients-with-relapsed-or-refractory-multiple-myeloma-302472043.html

https://www.prnewswire.com/news-releases/单次输注carvykti-ciltacabtagene-autoleucel为复发或难治性多发性骨髓瘤患者带来至少五年的持久无治疗缓解-302472043.html

SOURCE Johnson & Johnson

来源：强生公司

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