首创双特异性抗体TALVEY®和TECVAYLI®的联合研究显示，在接受过多次治疗且伴有髓外病变的多发性骨髓瘤患者中产生了深度且持久的反应-动脉网

Investigational combination of first-in-class bispecifics TALVEY® and TECVAYLI® shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease

CISION 等信源发布 2025-06-15 15:15



可切换为仅中文







Results from the Phase 2 RedirecTT-1 study demonstrate deep responses with

第2阶段RedirecTT-1研究的结果表明深度反应

78.9 percent overall response rate through dual targeting of GPRC5D and BCMA

通过双重靶向GPRC5D和BCMA，总体缓解率达到78.9%

Data signal potential of novel, off-the-shelf approach in patients

患者数据信号潜力的新颖、现成方法

with extramedullary disease who face significant unmet needs

伴有髓外病变，面临显著未满足需求的患者

MILAN

米兰

，

June 15

6月15日

, 2025

，2025

/PRNewswire/ -- Johnson & Johnson (NYSE:

/PRNewswire/ -- 强生公司（纽约证券交易所代码：

JNJ

强生公司

) announced today new results from the Phase 2 RedirecTT-1 study evaluating the investigational combination of TALVEY

）今天宣布了来自二期RedirecTT-1研究的新结果，该研究评估了TALVEY的实验性组合方案。

(talquetamab-tgvs), the first U.S. Food and Drug Administration (FDA)-approved GPRC5D-directed bispecific antibody, and TECVAYLI

（talquetamab-tgvs），首个获得美国食品药品监督管理局（FDA）批准的针对GPRC5D的双特异性抗体，以及TECVAYLI

(teclistamab-cqyv), the first FDA-approved BCMA-directed bispecific antibody. The results show a high overall response rate (ORR) with durability in patients with triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) who have true extramedullary disease (EMD). EMD is defined as soft tissue/organ-associated plasmacytomas with no contact to bony structures as per International Myeloma Working Group (IMWG) criteria..

（teclistamab-cqyv），是首款获得FDA批准的BCMA导向的双特异性抗体。结果显示，在患有真正髓外病变（EMD）的三类药物暴露（TCE）复发/难治性多发性骨髓瘤（RRMM）患者中，总体反应率（ORR）高且持久。根据国际骨髓瘤工作组（IMWG）标准，EMD被定义为与骨骼结构无接触的软组织/器官相关浆细胞瘤。

RedirecTT-1 is the largest study dedicated to patients with EMD to date. These data were featured in a late-breaking oral presentation (Abstract

RedirecTT-1 是迄今为止针对 EMD 患者规模最大的研究。这些数据在一场最新突破性口头报告中展示（摘要

#LB4001

) at the 2025 European Hematology Association (EHA) Congress.

) 在2025年欧洲血液学协会（EHA）大会上。

EMD represents an aggressive form of multiple myeloma and occurs when myeloma cells spread and form tumors (plasmacytomas) elsewhere in the body, such as in soft tissues and organs. These patients often face limited treatment options and worse outcomes due to the complexity of the disease, including tumor heterogeneity, resulting in low ORRs and rapid relapses with current standard therapies. On average, TCE RRMM patients with EMD have an ORR of less than 40 percent and a median progression-free survival (PFS) of less than 6 months..

EMD代表了一种侵袭性的多发性骨髓瘤形式，当骨髓瘤细胞扩散并在身体其他部位（如软组织和器官）形成肿瘤（浆细胞瘤）时发生。这些患者由于疾病复杂性，包括肿瘤异质性，往往面临有限的治疗选择和更差的预后，导致目前标准疗法的总体缓解率（ORR）较低且复发迅速。平均而言，伴有EMD的TCE复发/难治性多发性骨髓瘤（RRMM）患者的总体缓解率不到40%，中位无进展生存期（PFS）不到6个月。

'The investigational combination of TALVEY and TECVAYLI has demonstrated deep, durable responses in patients with relapsed or refractory multiple myeloma, and now shows great promise in those with extramedullary myeloma, where standard therapies often fall short,' said

“TALVEY 和 TECVAYLI 的研究性组合在复发或难治性多发性骨髓瘤患者中表现出深度且持久的反应，现在在髓外骨髓瘤患者中也显示出巨大的潜力，而标准疗法在此类情况中常常效果不佳，”

Yael Cohen

雅埃尔·科恩

, M.D., Head of Myeloma Unit, Tel-Aviv Sourasky Medical Center,

医学博士，特拉维夫苏拉斯基医疗中心骨髓瘤科主任，

Tel-Aviv, Israel

以色列特拉维夫

.* 'Dual targeting of GPRC5D and BCMA may lead to a higher ORR and greater depth of response by mitigating target antigen-related escape. The RedirecTT-1 trial shows the power of this novel dual-targeting combination approach as a potential treatment option for patients with this disease.'

.* “双靶向GPRC5D和BCMA可能通过减轻与靶抗原相关的逃逸，从而提高总体反应率（ORR）和更深层次的治疗反应。RedirecTT-1试验展示了这种新型双靶向组合方法作为该疾病患者潜在治疗选择的强大潜力。”

The Phase 2 RedirecTT-1 study enrolled 90 patients with TCE RRMM with true EMD. Of these patients, 84.4 percent were triple-class refractory, 35.6 percent were penta-drug refractory, 20 percent had previously received BCMA CAR-T therapy, and 8.9 percent had previously received a bispecific antibody..

第二阶段的RedirecTT-1研究招募了90名真正患有EMD的TCE复发/难治性多发性骨髓瘤（RRMM）患者。其中，84.4%的患者对三类药物耐药，35.6%的患者对五种药物耐药，20%的患者之前接受过BCMA CAR-T疗法，8.9%的患者之前接受过双特异性抗体治疗。

The investigational combination of TALVEY

TALVEY 的研究性组合

plus TECVAYLI

加上TECVAYLI

led to a high ORR of 78.9 percent (95 percent confidence interval [CI]; 69.0–86.8), with more than half of patients (54.4 percent) achieving complete response or better.

导致了78.9%的高客观缓解率（ORR）（95%置信区间[CI]：69.0-86.8），其中超过一半的患者（54.4%）达到了完全缓解或更好的效果。

High responses were observed even in patients exposed to prior BCMA CAR-T or anti-FcRH5 bispecific antibodies (83.3 percent ORR; 58.6-96.4 and 75 percent ORR; 34.9-96.8, respectively).

即使在先前接受过BCMA CAR-T或抗FcRH5双特异性抗体治疗的患者中，也观察到了较高的缓解率（分别为83.3％的客观缓解率；95％置信区间58.6-96.4和75％的客观缓解率；95％置信区间34.9-96.8）。

Among responders, 66.2 percent remained in response at the data cutoff, with a median follow-up of 13.4 months, signaling deep and durable responses.

在数据截止时，66.2%的应答者仍然保持应答，中位随访时间为13.4个月，这表明应答深刻且持久。

Treatment with the combination resulted in 61 percent of patients progression free and alive at one year.

联合治疗使61%的患者在一年内无进展且存活。

Additionally, the combination led to durable responses, with 64.1 percent of patients maintaining response (median duration of response: 13.8 months) and 74.5 percent of patients alive at one year, while median overall survival was not yet reached.

此外，该组合疗法带来了持久的响应，64.1%的患者维持了响应（中位响应持续时间：13.8个月），74.5%的患者在一年时仍然存活，而中位总生存期尚未达到。

'Patients with extramedullary myeloma, especially those who have exhausted prior therapies, need more effective treatment options,' said

“患有骨髓外骨髓瘤的患者，尤其是那些已经用尽先前疗法的患者，需要更有效的治疗选择，”

Jordan Schecter

乔丹·谢克特

, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. 'Our first-in-class bispecific antibodies TALVEY and TECVAYLI have transformed treatment for relapsed or refractory multiple myeloma. The RedirecTT-1 study underscores our commitment to advancing innovative therapies that attack the disease in different ways by building combinable and complementary regimens.'.

医学博士，副总裁，疾病领域领导者，多发性骨髓瘤，强生创新药物。 “我们首创的双特异性抗体TALVEY和TECVAYLI已经改变了复发或难治性多发性骨髓瘤的治疗方法。RedirecTT-1研究强调了我们致力于推进创新疗法的决心，这些疗法通过构建可组合和互补的治疗方案以不同的方式攻击疾病。”

The safety profile of the combination was consistent with previous reports of TALVEY

该组合的安全性特征与之前关于TALVEY的报告一致。

and TECVAYLI

和 TECVAYLI

as monotherapies, with no new safety signals identified.

作为单一疗法，未发现新的安全信号。

Patients were given the option to switch to once a month dosing, potentially contributing to improved tolerability. Rates of discontinuation were low with the treatment combination of TALVEY

患者可以选择改为每月一次的给药方案，这可能有助于提高耐受性。使用TALVEY治疗组合的停药率较低。

and TECVAYLI

和 TECVAYLI

due to adverse events (AEs).

由于不良事件（AEs）。

Four participants discontinued TALVEY

四名参与者停止了TALVEY的使用

only.

仅。

Reports of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) were mostly low grade.

CRS 和免疫效应细胞相关神经毒性综合征 (ICANS) 的报告大多为低级别。

Of the ten patients who had Grade 5 AEs (11.1 percent), five were due to infections and five were unrelated.

在10名出现5级不良事件（AE）的患者中（占11.1％），其中5例是由于感染，另外5例与感染无关。

The rates of severe infection were similar to those observed with BCMA bispecific antibody monotherapies.

严重感染的发生率与BCMA双特异性抗体单药治疗中观察到的相似。

bout TALVEY

关于TALVEY

TALVEY

塔尔维

(talquetamab-tgvs)

（talquetamab-tgvs）

received

已收到

approval from the U.S. FDA in

获得美国FDA批准在

August 2023

2023年8月

as a first-in-class GPRC5D-targeting bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

作为同类首创的GPRC5D靶向双特异性抗体，用于治疗既往接受过至少四种疗法（包括蛋白酶体抑制剂、免疫调节剂和抗CD38抗体）的复发或难治性多发性骨髓瘤成年患者。

Since FDA approval, more than 4,900 patients have been treated worldwide with TALVEY

自获得FDA批准以来，全球已有超过4900名患者接受了TALVEY的治疗。

. The European Commission (EC) granted

。欧洲委员会（EC）授予

conditional marketing authorization

有条件上市许可

(CMA) of TALVEY

TALVEY的CMA

▼ (talquetamab) in

▼ （talquetamab）在

August 2023

2023年8月

as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy..

作为一种单药疗法，用于治疗接受过至少三种先前疗法（包括一种免疫调节剂、一种蛋白酶体抑制剂和一种抗CD38抗体）并且在最后一次治疗中出现疾病进展的复发性和难治性多发性骨髓瘤（RRMM）成年患者。

TALVEY

塔尔维（TALVEY）

is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and G protein-coupled receptor class C group 5 member D (GPRC5D), a novel multiple myeloma target which is highly expressed on the surface of multiple myeloma cells and nonmalignant plasma cells, as well as some healthy tissues such as epithelial cells of the skin and tongue. .

是一种双特异性T细胞结合抗体，它结合到T细胞表面表达的CD3受体和G蛋白偶联受体C类第5组成员D（GPRC5D），这是一个新型多发性骨髓瘤靶点，在多发性骨髓瘤细胞和非恶性浆细胞表面高度表达，同时也表达在一些健康组织上，如皮肤和舌头的上皮细胞。

About TECVAYLI

关于TECVAYLI

TECVAYLI

(teclistamab-cqyv)

（特克利斯塔单抗-cqyv）

received

收到

approval from the U.S. FDA in

获得美国FDA批准在

October 2022

2022年10月

as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.[6] Since FDA approval, more than 15,900 patients have been treated worldwide with TECVAYLI.

作为一种现成（或即用型）抗体，通过皮下注射给药，用于治疗接受过至少四种既往治疗方案（包括蛋白酶体抑制剂、免疫调节剂和抗CD38抗体）的复发性或难治性多发性骨髓瘤（RRMM）成年患者。自获得FDA批准以来，全球已有超过15,900名患者接受了TECVAYLI治疗。

. The European Commission (EC) granted TECVAYLI

欧洲委员会 (EC) 批准了 TECVAYLI

conditional marketing authorization

有条件上市许可

(CMA) in

（CMA）在

August 2022

2022年8月

as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy. In

作为单药疗法，用于治疗已接受过至少三种先前疗法（包括蛋白酶体抑制剂、免疫调节剂和抗CD38抗体）并且自上次治疗以来已显示疾病进展的成人RRMM患者。

August 2023

2023年8月

, the EC

，欧盟委员会

granted the approval

批准通过

of a Type II variation application for TECVAYLI

TECVAYLI的II型变更申请

, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients who have achieved a complete response (CR) or better for a minimum of six months. TECVAYLI

，为已达到完全缓解（CR）或更好状态至少六个月的患者提供每两周一次（Q2W）1.5 mg/kg 的减量给药频率选择。TECVAYLI

is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells.

是一种同类首创的双特异性T细胞衔接抗体疗法，它运用创新科学，通过与T细胞表面表达的CD3受体和多发性骨髓瘤细胞及部分健康B系细胞表面表达的B细胞成熟抗原（BCMA）结合，激活免疫系统。

In .

在。

February 2024

2024年2月

, the U.S. FDA

，美国食品药品监督管理局

approved

已批准

the supplemental Biologics License Application (sBLA) for TECVAYLI

TECVAYLI的补充生物制品许可申请（sBLA）

for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients with relapsed or refractory multiple myeloma who have achieved and maintained a CR or better for a minimum of six months.

对于复发或难治性多发性骨髓瘤患者，若已达到并维持完全缓解（CR）或更好状态至少六个月，可将剂量频率减少为每两周1.5 mg/kg。

For more information, visit

欲了解更多信息，请访问

www.TECVAYLI.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，它影响一种称为浆细胞的白细胞，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，并用肿瘤取代骨髓中的正常细胞。

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，而超过12,000人将死于该疾病。

People living with multiple myeloma have a 5-year survival rate of 59.8 percent.[11] 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..

多发性骨髓瘤患者的五年生存率为 59.8%。[11] 虽然一些被诊断为多发性骨髓瘤的人最初没有症状，但大多数患者因症状而被诊断出来，这些症状可能包括骨折或疼痛、红细胞计数低、疲倦、高钙水平以及肾功能问题或感染。

，

TALVEY

塔尔维

IMPORTANT SAFETY INFORMATION

重要安全信息

INDICATION AND USAGE

适应症和用途

TALVEY

塔尔维

(talquetamab-tgvs) is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

（talquetamab-tgvs）适用于治疗接受过至少四种既往治疗方案的复发或难治性多发性骨髓瘤成年患者，这些治疗方案包括蛋白酶体抑制剂、免疫调节剂和抗CD38单克隆抗体。

This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

该适应症是基于缓解率和缓解持续时间获得加速批准的。此适应症的持续批准可能取决于在确证性试验中对临床获益的验证和描述。

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

警告：细胞因子释放综合征和神经毒性，包括免疫效应细胞相关神经毒性综合征

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TALVEY

接受TALVEY治疗的患者可能会出现细胞因子释放综合征（CRS），包括可能危及生命或致命的反应。

. Initiate TALVEY

. 启动 TALVEY

treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY

采用逐步增加剂量的治疗方案以降低CRS风险。暂停使用TALVEY

until CRS resolves or permanently discontinue based on severity.

直到CRS解决或根据严重程度永久停止。

Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life-threatening or fatal reactions, can occur with TALVEY®. Monitor patients for signs and symptoms of neurologic toxicity including ICANS during treatment and treat promptly. Withhold or permanently discontinue TALVEY.

神经毒性，包括免疫效应细胞相关神经毒性综合征 (ICANS)，以及严重、危及生命或致命的反应，可能在使用 TALVEY® 时发生。治疗期间应监测患者是否出现包括 ICANS 在内的神经毒性症状和体征，并及时处理。暂停或永久停止使用 TALVEY。

based on severity.

基于严重程度。

Because of the risk of CRS and neurologic toxicity, including ICANS, TALVEY

由于存在CRS和包括ICANS在内的神经毒性风险，TALVEY

is available only through a restricted program called the TECVAYLI

仅通过名为TECVAYLI的受限计划提供

and TALVEY

和TALVEY

Risk Evaluation and Mitigation Strategy (REMS).

风险评估与缓解策略 (REMS)。

CONTRAINDICATIONS:

禁忌症：

None.

无。

WARNINGS AND PRECAUTIONS

警告和注意事项

Cytokine Release Syndrome (CRS):

细胞因子释放综合征（CRS）：

TALVEY

塔尔维

can cause cytokine release syndrome, including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 76% of patients who received TALVEY

可能引起细胞因子释放综合征，包括危及生命或致命的反应。在临床试验中，76%接受TALVEY治疗的患者发生了CRS。

at the recommended dosages, with Grade 1 CRS occurring in 57% of patients, Grade 2 in 17%, and Grade 3 in 1.5%. Recurrent CRS occurred in 30% of patients. Most events occurred following step-up dose 1 (29%) or step-up dose 2(44%) at the recommended dosages. CRS occurred in 33% of patients with step-up dose 3 in the biweekly dosing schedule (N=153).

在推荐剂量下，57% 的患者发生 1 级 CRS，17% 的患者发生 2 级，1.5% 的患者发生 3 级。30% 的患者出现复发性 CRS。大多数事件发生在推荐剂量下的递增剂量 1（29%）或递增剂量 2（44%）之后。在双周给药方案中，33% 的患者在递增剂量 3 时发生 CRS（N=153）。

CRS occurred in 30% of patients with the first 0.4 mg/kg treatment dose and in 12% of patients treated with the first 0.8 mg/kg treatment dose. The CRS rate for both dosing schedules combined was less than 3% for each of the remaining doses in Cycle 1 and less than 3% cumulatively from Cycle 2 onward.

在首次接受0.4 mg/kg治疗剂量的患者中，30%发生了CRS；在首次接受0.8 mg/kg治疗剂量的患者中，12%发生了CRS。对于两种剂量方案合并来看，在第一周期的其余剂量中，CRS发生率均低于3%，从第二周期起，累计CRS发生率也低于3%。

The median time to onset of CRS was 27 (range: 0.1 to 167) hours from the last dose, and the median duration was 17 (range: 0 to 622) hours. Clinical signs and symptoms of CRS include but are not limited to pyrexia, hypotension, chills, hypoxia, headache, and tachycardia. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC). .

从最后一次给药开始，CRS发生的中位时间为27小时（范围：0.1至167小时），中位持续时间为17小时（范围：0至622小时）。CRS的临床体征和症状包括但不限于发热、低血压、寒战、低氧血症、头痛和心动过速。CRS可能危及生命的并发症包括心脏功能障碍、急性呼吸窘迫综合征、神经毒性、肾和/或肝衰竭以及弥散性血管内凝血（DIC）。

Initiate therapy with step-up dosing and administer pre-treatment medications (corticosteroids, antihistamine, and antipyretics) prior to each dose of TALVEY

开始逐步加量治疗，并在每次给予TALVEY之前使用预处理药物（皮质类固醇、抗组胺药和退烧药）。

in the step-up dosing schedule to reduce the risk of CRS. Monitor patients following administration accordingly. In patients who experience CRS, pre-treatment medications should be administered prior to the next TALVEY

在逐步增加剂量的日程安排中以降低CRS的风险。根据相应要求，在给药后监测患者。对于经历CRS的患者，在下次使用TALVEY前应给予预处理药物。

dose.

剂量。

Counsel patients to seek medical attention should signs or symptoms of CRS occur. At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care based on severity, and consider further management per current practice guidelines. Withhold TALVEY.

告知患者，如果出现CRS的体征或症状，应寻求医疗关注。在出现CRS的第一个迹象时，立即评估患者是否需要住院，并根据严重程度开始支持性治疗，同时考虑按照现行实践指南进行进一步管理。暂停使用TALVEY。

until CRS resolves or permanently discontinue based on severity.

直到CRS解决或根据严重程度永久停止。

Neurologic Toxicity including ICANS:

神经毒性，包括ICANS：

TALVEY

塔尔vey

can cause serious, or life-threatening neurologic toxicity or fatal neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS), including fatal reactions. In the clinical trial, neurologic toxicity, including ICANS, occurred in 55% of patients who received the recommended dosages, with Grade 3 or 4 neurologic toxicity occurring in 6% of patients.

可能导致严重或危及生命的神经毒性，包括致死性神经毒性，以及免疫效应细胞相关神经毒性综合征 (ICANS)，包括致死性反应。在临床试验中，接受推荐剂量的患者中有55%出现神经毒性（包括ICANS），其中6%的患者出现3级或4级神经毒性。

The most frequent neurologic toxicities were headache (20%), encephalopathy (15%), sensory neuropathy (14%), and motor dysfunction (10%). .

最常见的神经毒性是头痛（20%）、脑病（15%）、感觉神经病变（14%）和运动功能障碍（10%）。

ICANS was reported in 9% of 265 patients where ICANS was collected and who received the recommended dosages. Recurrent ICANS occurred in 3% of patients. Most patients experienced ICANS following step-up dose 1 (3%), step-up dose 2 (3%), step-up dose 3 of the biweekly dosing schedule (1.8%), or the initial treatment dose of the weekly dosing schedule (2.6%) (N=156) or the biweekly dosing schedule (3.7%) (N=109).

在收集到的265名接受推荐剂量的患者中，有9%报告了ICANS。其中3%的患者出现了复发性ICANS。大多数患者在以下情况下经历了ICANS：第一阶梯剂量（3%）、第二阶梯剂量（3%）、双周给药计划的第三阶梯剂量（1.8%）、每周给药计划的初始治疗剂量（2.6%）（N=156），或双周给药计划（3.7%）（N=109）。

The median time to onset of ICANS was 2.5 (range: 1 to 16) days after the most recent dose with a median duration of 2 (range: 1 to 22) days. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia. .

ICANS 的中位发病时间为最近一次给药后 2.5 天（范围：1 至 16 天），中位持续时间为 2 天（范围：1 至 22 天）。ICANS 的发病可能与 CRS 同时发生，可能在 CRS 消退后出现，也可能在没有 CRS 的情况下发生。ICANS 的临床体征和症状可能包括但不限于意识模糊、意识水平下降、定向障碍、嗜睡、乏力和思维迟缓。

Monitor patients for signs and symptoms of neurologic toxicity during treatment and treat promptly. At the first sign of neurologic toxicity, including ICANS, immediately evaluate the patient and provide supportive care based on severity. Withhold or permanently discontinue TALVEY

在治疗期间监测患者神经毒性症状和体征，并及时治疗。一旦出现神经毒性症状，包括ICANS，立即评估患者并根据严重程度提供支持性护理。暂停或永久停止TALVEY。

based on severity and consider further management per current practice guidelines [see Dosage and Administration (2.5)].

基于严重程度，并根据现行实践指南考虑进一步管理 [见剂量和用法 (2.5)]。

Due to the potential for neurologic toxicity, patients receiving TALVEY

由于可能存在神经毒性，接受TALVEY治疗的患者

are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during the step-up dosing schedule and for 48 hours after completion of the step-up dosing schedule, and in the event of new onset of any neurological symptoms, until symptoms resolve. .

有意识水平下降的风险。建议患者在逐步增加剂量期间及完成逐步增加剂量后的48小时内，以及在出现任何新发神经系统症状时，直至症状消退前，避免驾驶或操作重型或潜在危险的机械。

TECVAYLI

and TALVEY

和TALVEY

REMS:

风险评估与缓解策略：

TALVEY

塔尔维

is available only through a restricted program under a REMS, called the TECVAYLI

仅通过REMS下的受限计划提供，称为TECVAYLI

and TALVEY

和TALVEY

REMS because of the risks of CRS and neurologic toxicity, including ICANS.

由于CRS和包括ICANS在内的神经毒性风险，REMS。

Further information about the TECVAYLI

有关TECVAYLI的更多信息

and TALVEY

和TALVEY

REMS program is available at

REMS 程序可在此处获取

www.TEC-TALREMS.com

or by telephone at 1-855-810-8064.

或拨打1-855-810-8064电话。

Oral Toxicity and Weight Loss:

口服毒性和体重减轻：

TALVEY

塔尔vey

can cause oral toxicities, including dysgeusia, dry mouth, dysphagia, and stomatitis. In the clinical trial, 80% of patients had oral toxicity, with Grade 3 occurring in 2.1% of patients who received the recommended dosages. The most frequent oral toxicities were dysgeusia (49%), dry mouth (34%), dysphagia (23%), and ageusia (18%).

可能导致口腔毒性，包括味觉异常、口干、吞咽困难和口腔炎。在临床试验中，80%的患者出现口腔毒性，其中2.1%的患者在推荐剂量下发生3级毒性。最常见的口腔毒性为味觉异常（49%）、口干（34%）、吞咽困难（23%）和味觉丧失（18%）。

The median time to onset of oral toxicity was 15 (range: 1 to 634) days, and the median time to resolution to baseline was 43 (1 to 530) days. Oral toxicity did not resolve to baseline in 65% of patients. .

口腔毒性的中位发病时间为15天（范围：1至634天），恢复到基线的中位时间为43天（1至530天）。65%的患者口腔毒性未恢复到基线水平。

TALVEY

塔尔维

can cause weight loss. In the clinical trial, 62% of patients experienced weight loss, regardless of having an oral toxicity, including 29% of patients with Grade 2 (10% or greater) weight loss and 2.7% of patients with Grade 3 (20% or greater) weight loss. The median time to onset of Grade 2 or higher weight loss was 67 (range: 6 to 407) days, and the median time to resolution was 50 (range: 1 to 403) days.

可能导致体重减轻。在临床试验中，62%的患者出现体重减轻，无论是否存在口腔毒性，其中29%的患者体重减轻达到2级（10%或以上），2.7%的患者体重减轻达到3级（20%或以上）。2级或更高级别体重减轻的中位发病时间为67天（范围：6至407天），中位缓解时间为50天（范围：1至403天）。

Weight loss did not resolve in 57% of patients who reported weight loss. .

据报道，57%的患者体重减轻问题没有得到解决。

Monitor patients for signs and symptoms of oral toxicity. Counsel patients to seek medical attention should signs or symptoms of oral toxicity occur and provide supportive care as per current clinical practice, including consultation with a nutritionist. Monitor weight regularly during therapy. Evaluate clinically significant weight loss further.

监测患者是否有口腔毒性的体征和症状。建议患者如果出现口腔毒性的体征或症状，应寻求医疗关注，并根据现行临床实践提供支持性护理，包括咨询营养师。在治疗期间定期监测体重。进一步评估有临床意义的体重减轻。

Withhold TALVEY.

暂停使用TALVEY。

or permanently discontinue based on severity.

或根据严重程度永久停止。

Infections:

感染:

TALVEY

塔尔维

can cause infections, including life-threatening or fatal infections. Serious infections occurred in 16% of patients, with fatal infections in 1.5% of patients. Grade 3 or 4 infections occurred in 17% of patients. The most common serious infections reported were bacterial infection (8%), which included sepsis and COVID-19 (2.7%). .

可能导致感染，包括危及生命或致命的感染。16%的患者发生了严重感染，其中1.5%的患者发生了致命感染。17%的患者发生了3级或4级感染。报告的最常见的严重感染是细菌感染（8%），其中包括败血症和新冠肺炎（2.7%）。

Monitor patients for signs and symptoms of infection prior to and during treatment with TALVEY

在使用TALVEY治疗前和治疗期间，监测患者是否出现感染的体征和症状。

and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Withhold or consider permanent discontinuation of TALVEY

并适当治疗。根据当地指南给予预防性抗菌药物。暂停或考虑永久停用TALVEY。

as recommended, based on severity.

根据严重程度，按推荐进行。

Cytopenias:

血细胞减少症：

TALVEY

塔尔维

can cause cytopenias, including neutropenia and thrombocytopenia. In the clinical trial, Grade 3 or 4 decreased neutrophils occurred in 35% of patients, and Grade 3 or 4 decreased platelets occurred in 22% of patients who received TALVEY

可能导致包括中性粒细胞减少和血小板减少在内的细胞减少症。在临床试验中，35%的患者出现3级或4级中性粒细胞减少，22%的接受TALVEY治疗的患者出现3级或4级血小板减少。

. The median time to onset for Grade 3 or 4 neutropenia was 22 (range: 1 to 312) days, and the median time to resolution to Grade 2 or lower was 8 (range: 1 to 79) days. The median time to onset for Grade 3 or 4 thrombocytopenia was 12 (range: 2 to 183) days, and the median time to resolution to Grade 2 or lower was 10 (range: 1 to 64) days.

3级或4级中性粒细胞减少的中位发病时间为22天（范围：1至312天），降至2级或更低的中位缓解时间为8天（范围：1至79天）。3级或4级血小板减少的中位发病时间为12天（范围：2至183天），降至2级或更低的中位缓解时间为10天（范围：1至64天）。

Monitor complete blood counts during treatment and withhold TALVEY.

在治疗期间监测全血细胞计数，并暂停使用TALVEY。

as recommended, based on severity.

根据严重程度，推荐使用。

Skin Toxicity:

皮肤毒性：

TALVEY

塔尔维

can cause serious skin reactions, including rash, maculo-papular rash, erythema, and erythematous rash. In the clinical trial, skin reactions occurred in 62% of patients, with Grade 3 skin reactions in 0.3%. The median time to onset was 25 (range: 1 to 630) days. The median time to improvement to Grade 1 or less was 33 days. .

可能导致严重的皮肤反应，包括皮疹、斑丘疹、红斑和红斑性皮疹。在临床试验中，62%的患者出现皮肤反应，其中0.3%为3级皮肤反应。出现反应的中位时间为25天（范围：1至630天）。改善至1级或以下的中位时间为33天。

Monitor for skin toxicity, including rash progression. Consider early intervention and treatment to manage skin toxicity. Withhold TALVEY

监测皮肤毒性，包括皮疹进展。考虑早期干预和治疗以管理皮肤毒性。暂停使用TALVEY。

as recommended based on severity.

根据严重程度推荐。

Hepatotoxicity:

肝毒性：

TALVEY

塔尔vey

can cause hepatotoxicity. Elevated ALT occurred in 33% of patients, with Grade 3 or 4 ALT elevation occurring in 2.7%; elevated AST occurred in 31% of patients, with Grade 3 or 4 AST elevation occurring in 3.3%. Grade 3 or 4 elevations of total bilirubin occurred in 0.3% of patients. Liver enzyme elevation can occur with or without concurrent CRS. .

可能导致肝毒性。33%的患者出现ALT升高，其中2.7%的患者出现3级或4级ALT升高；31%的患者出现AST升高，其中3.3%的患者出现3级或4级AST升高。0.3%的患者出现总胆红素的3级或4级升高。肝酶升高可能伴有或不伴有同时发生的CRS。

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TALVEY

在基线和治疗期间根据临床需要监测肝酶和胆红素。暂停使用TALVEY。

or consider permanent discontinuation of TALVEY

或考虑永久停止使用TALVEY

, based on severity [see Dosage and Administration (2.5)].

，根据严重程度[见剂量和用法 (2.5)]。

Embryo-Fetal Toxicity:

胚胎-胎儿毒性：

Based on its mechanism of action, TALVEY

基于其作用机制，TALVEY

may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TALVEY

可能在给孕妇使用时对胎儿造成伤害。告知孕妇对胎儿的潜在风险。建议有生育潜力的女性在使用TALVEY治疗期间使用有效的避孕措施。

and for 3 months after the last dose.

在最后一剂后的3个月内。

Adverse Reactions:

不良反应：

The most common adverse reactions (≥20%) are pyrexia, CRS, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, weight decreased, dry mouth, xerosis, dysphagia, upper respiratory tract infection, diarrhea, hypotension, and headache.

最常见的不良反应（≥20%）包括发热、CRS、味觉障碍、指甲疾病、肌肉骨骼疼痛、皮肤疾病、皮疹、疲劳、体重减轻、口干、干燥症、吞咽困难、上呼吸道感染、腹泻、低血压和头痛。

The most common Grade 3 or 4 laboratory abnormalities (≥30%) are lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, and hemoglobin decreased.

最常见的 3 级或 4 级实验室异常（≥30%）是淋巴细胞计数减少、中性粒细胞计数减少、白细胞减少和血红蛋白减少。

Please read full

请阅读全文

Prescribing Information

处方信息

，

including Boxed WARNING, for TALVEY

包括TALVEY的盒装警告，

。

TECVAYLI

IMPORTANT SAFETY INFORMATION

重要的安全信息

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

警告：细胞因子释放综合征和神经毒性，包括免疫效应细胞相关神经毒性综合征

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI

接受TECVAYLI治疗的患者可能会出现细胞因子释放综合征（CRS），包括可能危及生命或致命的反应。

. Initiate treatment with TECVAYLI

. 开始使用TECVAYLI进行治疗

step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI

逐步增加剂量以降低CRS风险。暂停使用TECVAYLI。

until CRS resolves or permanently discontinue based on severity.

直到CRS解决或根据严重程度永久停止。

Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and life-threatening reactions, can occur in patients receiving TECVAYLI

接受TECVAYLI治疗的患者可能会出现神经毒性，包括免疫效应细胞相关神经毒性综合征（ICANS）以及严重和危及生命的反应。

. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI

在治疗期间，监测患者神经毒性症状或体征，包括ICANS。暂停使用TECVAYLI。

until neurologic toxicity resolves or permanently discontinue based on severity.

直到神经毒性恢复或根据严重程度永久停用。

TECVAYLI

特西瓦利

is available only through a restricted program called the TECVAYLI

仅通过名为TECVAYLI的受限计划提供

and TALVEY

和TALVEY

Risk Evaluation and Mitigation Strategy (REMS).

风险评估与缓解策略 (REMS)。

INDICATION AND USAGE

适应症和用途

TECVAYLI

(teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. .

(teclistamab-cqyv) 是一种双特异性B细胞成熟抗原（BCMA）导向的CD3 T细胞接合器，用于治疗接受过至少四种既往治疗（包括蛋白酶体抑制剂、免疫调节剂和抗CD38单克隆抗体）的复发或难治性多发性骨髓瘤成年患者。

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

该适应症是基于缓解率通过加速审批程序批准的。此适应症的持续批准可能取决于在确证性试验中对临床获益的验证和描述。

WARNINGS AND PRECAUTIONS

警告和注意事项

Cytokine Release Syndrome

细胞因子释放综合征

TECVAYLI

特克瓦利

can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 72% of patients who received TECVAYLI

可能引起细胞因子释放综合征 (CRS)，包括危及生命或致命的反应。在临床试验中，72% 接受 TECVAYLI 的患者发生了 CRS。

at the recommended dose, with Grade 1 CRS occurring in 50% of patients, Grade 2 in 21%, and Grade 3 in 0.6%. Recurrent CRS occurred in 33% of patients. Most patients experienced CRS following step-up dose 1 (42%), step-up dose 2 (35%), or the initial treatment dose (24%). Less than 3% of patients developed first occurrence of CRS following subsequent doses of TECVAYLI.

在推荐剂量下，50%的患者发生1级CRS，21%的患者发生2级CRS，0.6%的患者发生3级CRS。33%的患者出现复发性CRS。大多数患者在递增剂量1（42%）、递增剂量2（35%）或初始治疗剂量（24%）后经历CRS。不到3%的患者在后续TECVAYLI剂量后首次出现CRS。

. The median time to onset of CRS was 2 (range: 1 to 6) days after the most recent dose with a median duration of 2 (range: 1 to 9) days. Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation). .

细胞因子释放综合征（CRS）的中位发病时间为最近一次给药后2天（范围：1至6天），中位持续时间为2天（范围：1至9天）。CRS的临床症状和体征包括但不限于发热、低氧血症、寒战、低血压、窦性心动过速、头痛以及肝酶升高（天冬氨酸氨基转移酶和丙氨酸氨基转移酶升高）。

Initiate therapy according to TECVAYLI

根据TECVAYLI启动治疗

step-up dosing schedule to reduce risk of CRS. Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI

逐步增加剂量以降低CRS风险。给予预处理药物以减少CRS风险，并在给予TECVAYLI后监测患者。

accordingly. At the first sign of CRS, immediately evaluate patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold or permanently discontinue TECVAYLI

相应地，在出现CRS的第一个迹象时，立即评估患者是否需要住院。根据严重程度提供支持性护理，并考虑按照现行的实践指南进行进一步管理。暂停或永久停止TECVAYLI。

based on severity.

基于严重程度。

TECVAYLI

is available only through a restricted program under a REMS.

只能通过REMS下的受限计划获得。

Neurologic Toxicity including ICANS

神经毒性，包括ICANS

TECVAYLI

can cause serious or life-threatening neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).

可能引起严重或危及生命的神经毒性，包括免疫效应细胞相关神经毒性综合征 (ICANS)。

In the clinical trial, neurologic toxicity occurred in 57% of patients who received TECVAYLI

在临床试验中，接受TECVAYLI治疗的患者中有57%发生了神经毒性。

at the recommended dose, with Grade 3 or 4 neurologic toxicity occurring in 2.4% of patients. The most frequent neurologic toxicities were headache (25%), motor dysfunction (16%), sensory neuropathy (15%), and encephalopathy (13%). With longer follow-up, Grade 4 seizure and fatal Guillain-Barré syndrome (one patient each) occurred in patients who received TECVAYLI.

在推荐剂量下，2.4%的患者出现3级或4级神经毒性。最常见的神经毒性包括头痛（25%）、运动功能障碍（16%）、感觉神经病变（15%）和脑病（13%）。随着更长的随访时间，接受TECVAYLI的患者中出现了4级癫痫发作和致命的吉兰-巴雷综合征（各一例）。

。

In the clinical trial, ICANS was reported in 6% of patients who received TECVAYLI

在临床试验中，接受TECVAYLI治疗的患者中有6%报告了ICANS。

at the recommended dose. Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent doses of TECVAYLI

在推荐剂量下，1.8%的患者出现了复发性ICANS。大多数患者在递增剂量1（1.2%）、递增剂量2（0.6%）或初始治疗剂量（1.8%）后经历了ICANS。不到3%的患者在后续TECVAYLI剂量后首次出现ICANS。

. The median time to onset of ICANS was 4 (range: 2 to 8) days after the most recent dose with a median duration of 3 (range: 1 to 20) days. The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. .

ICANS的中位发病时间为最近一次给药后4天（范围：2至8天），中位持续时间为3天（范围：1至20天）。报告的ICANS最常见的临床表现是意识混乱和书写困难。ICANS的发病可以与CRS同时发生，可以在CRS消退后发生，也可能在没有CRS的情况下发生。

Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold or permanently discontinue TECVAYLI

在治疗期间监测患者神经毒性症状和体征。一旦出现神经毒性症状，包括ICANS，立即评估患者并根据严重程度提供支持性治疗。暂停或永久停止使用TECVAYLI。

based on severity per recommendations and consider further management per current practice guidelines.

根据严重程度遵循建议，并考虑按照当前实践指南进行进一步管理。

Due to the potential for neurologic toxicity, patients are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI

由于存在神经毒性风险，患者可能出现意识水平下降。建议患者在使用TECVAYLI期间及治疗结束后48小时内避免驾驶或操作重型或潜在危险机械。

step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves.

逐步增加剂量计划，并在出现任何新的神经毒性症状时，直到神经毒性症状消退。

TECVAYLI

is available only through a restricted program under a REMS.

只能通过REMS下的受限计划获得。

TECVAYLI

特克瓦伊利

and TALVEY

和TALVEY

REMS -

风险评估与缓解策略 (REMS) -

TECVAYLI

特克瓦利

is available only through a restricted program under a REMS called the TECVAYLI

仅通过名为TECVAYLI的REMS限制程序提供

and TALVEY

和TALVEY

REMS because of the risks of CRS and neurologic toxicity, including ICANS.

由于CRS和包括ICANS在内的神经毒性风险，REMS。

Hepatotoxicity -

肝毒性 -

TECVAYLI

特克瓦伊利

can cause hepatotoxicity, including fatalities. In patients who received TECVAYLI

可能导致肝毒性，包括死亡。在接受TECVAYLI治疗的患者中

at the recommended dose in the clinical trial, there was one fatal case of hepatic failure. Elevated aspartate aminotransferase (AST) occurred in 34% of patients, with Grade 3 or 4 elevations in 1.2%. Elevated alanine aminotransferase (ALT) occurred in 28% of patients, with Grade 3 or 4 elevations in 1.8%.

在临床试验的推荐剂量下，出现了一例致命的肝衰竭病例。34% 的患者出现了天冬氨酸氨基转移酶 (AST) 升高，其中 1.2% 的患者为 3 级或 4 级升高。28% 的患者出现了丙氨酸氨基转移酶 (ALT) 升高，其中 1.8% 的患者为 3 级或 4 级升高。

Elevated total bilirubin occurred in 6% of patients with Grade 3 or 4 elevations in 0.6%. Liver enzyme elevation can occur with or without concurrent CRS. .

总胆红素升高发生在6%的患者中，其中3级或4级升高的比例为0.6%。肝酶升高可以伴随或不伴随CRS同时发生。

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI

在基线和治疗期间根据临床需要监测肝酶和胆红素。暂停TECVAYLI

or consider permanent discontinuation of TECVAYLI

或考虑永久停止使用TECVAYLI

based on severity.

基于严重程度。

Infections -

感染 -

TECVAYLI

特克瓦伊利

can cause severe, life-threatening, or fatal infections. In patients who received TECVAYLI

可能导致严重、危及生命或致命的感染。在接种TECVAYLI的患者中

at the recommended dose in the clinical trial, serious infections, including opportunistic infections, occurred in 30% of patients, with Grade 3 or 4 infections in 35%, and fatal infections in 4.2%. Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI

在临床试验中，推荐剂量下，30%的患者发生了严重感染，包括机会性感染，35%的患者发生了3级或4级感染，4.2%的患者发生了致命感染。在使用TECVAYLI治疗前和治疗期间，应监测患者的感染迹象和症状。

and treat appropriately. Administer prophylactic antimicrobials according to guidelines. Withhold TECVAYLI

并适当治疗。根据指南给予预防性抗菌药物。停用TECVAYLI

or consider permanent discontinuation of TECVAYLI

或考虑永久停止使用TECVAYLI

based on severity.

基于严重程度。

Monitor immunoglobulin levels during treatment with TECVAYLI

在使用TECVAYLI治疗期间监测免疫球蛋白水平

and treat according to guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

根据指南进行治疗，包括感染预防和抗生素或抗病毒预防。

Neutropenia -

中性粒细胞减少症 -

TECVAYLI

特克瓦利

can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI

可能导致中性粒细胞减少和发热性中性粒细胞减少。在接受TECVAYLI的患者中

at the recommended dose in the clinical trial, decreased neutrophils occurred in 84% of patients, with Grade 3 or 4 decreased neutrophils in 56%. Febrile neutropenia occurred in 3% of patients.

在临床试验中，推荐剂量下，84%的患者出现中性粒细胞减少，其中56%为3级或4级中性粒细胞减少。3%的患者出现发热性中性粒细胞减少。

Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines. Monitor patients with neutropenia for signs of infection. Withhold TECVAYLI

在基线时和治疗期间定期监测全血细胞计数，并根据当地机构指南提供支持性护理。监测中性粒细胞减少症患者的感染迹象。暂停使用TECVAYLI。

based on severity.

基于严重程度。

Hypersensitivity and Other Administration Reactions -

超敏反应及其他管理反应 -

TECVAYLI

can cause both systemic administration-related and local injection-site reactions.

可能导致全身给药相关的反应和局部注射部位的反应。

Systemic Reactions

全身性反应

- In patients who received TECVAYLI

- 在接受TECVAYLI治疗的患者中

at the recommended dose in the clinical trial, 1.2% of patients experienced systemic-administration reactions, which included Grade 1 recurrent pyrexia and Grade 1 swollen tongue.

在临床试验中，按推荐剂量，1.2% 的患者出现了全身给药反应，其中包括 1 级反复发热和 1 级舌头肿胀。

Local Reactions

局部反应

- In patients who received TECVAYLI

- 在接受TECVAYLI治疗的患者中

at the recommended dose in the clinical trial, injection-site reactions occurred in 35% of patients, with Grade 1 injection-site reactions in 30% and Grade 2 in 4.8%. Withhold TECVAYLI

在临床试验中，按推荐剂量，35%的患者出现注射部位反应，其中30%为1级注射部位反应，4.8%为2级。应暂停使用TECVAYLI。

or consider permanent discontinuation of TECVAYLI

或考虑永久停止使用TECVAYLI

based on severity.

基于严重程度。

Embryo-Fetal Toxicity -

胚胎-胎儿毒性 -

Based on its mechanism of action, TECVAYLI

基于其作用机制，TECVAYLI

在给孕妇使用时可能会对胎儿造成伤害。告知孕妇对胎儿的潜在风险。建议有生殖潜力的女性在使用TECVAYLI治疗期间采取有效的避孕措施。

and for 5 months after the last dose.

在最后一剂后的5个月内。

ADVERSE REACTIONS

不良反应

The most common adverse reactions (≥20%) were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets. .

最常见的不良反应（≥20%）为发热、CRS、肌肉骨骼疼痛、注射部位反应、疲劳、上呼吸道感染、恶心、头痛、肺炎和腹泻。最常见的3至4级实验室异常（≥20%）为淋巴细胞减少、中性粒细胞减少、白细胞减少、血红蛋白减少和血小板减少。

Please read full

请阅读全文

Prescribing Information

处方信息

, including Boxed WARNING, for TECVAYLI

，包括TECVAYLI的盒装警告，

。

About Johnson & Johnson

关于强生公司

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实力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更少侵入性，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长，我们具备独特的优势，能够在当今整个医疗保健解决方案领域进行创新，提供未来的突破性成果，并对人类健康产生深远影响。

Learn more at .

了解更多信息，请访问 。

https://www.jnj.com/

or at

或在

www.innovativemedicine.jnj.com

. Follow us at

关注我们

@JNJInnovMed

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

杨森研发有限责任公司、杨森生物科技公司、杨森全球服务有限责任公司和杨森科学事务有限责任公司是强生公司的子公司。

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 TALVEY

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

(talquetamab-tgvs) and TECVAYLI

（talquetamab-tgvs）和 TECVAYLI

(teclistamab-cqyv). 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.

（teclistamab-cqyv）。读者应注意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变为现实，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以及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、竞争对手的新产品和专利；专利挑战；因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10-K表格年度报告，包括标题为“关于前瞻性陈述的警示说明”和“项目1A. 风险因素”的部分，以及强生公司随后的10-Q表格季度报告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。

Source: Johnson & Johnson

来源：强生公司

Yael Cohen

雅埃尔·科恩

, M.D., Head of Myeloma Unit, Tel-Aviv Sourasky Medical Center,

医学博士，特拉维夫苏拉斯基医疗中心骨髓瘤科主任，

Tel-Aviv, Israel

特拉维夫，以色列

, has provided consulting, advisory, and speaking services to Johnson & Johnson; she has not been paid for any media work.

，曾为强生公司提供咨询、顾问和演讲服务；她没有因任何媒体工作获得报酬。

Ho, M.; Paruzzo, L.; Minehart, J.; Nabar, N.; Noll, J.H.; Luo, T.; Garfall, A.; Zanwar, S. Extramedullary Multiple Myeloma: Challenges and Opportunities. Curr. Oncol. 2025, 32, 182.

霍，M.; 帕鲁佐，L.; 米内哈特，J.; 纳巴尔，N.; 诺尔，J.H.; 罗，T.; 加法尔，A.; 赞瓦尔，S. 髓外多发性骨髓瘤：挑战与机遇。《当代肿瘤学》2025，32，182。

https://doi.org/10.3390/curroncol32030182

Philippe Moreau et al, Outcomes of Patients With Extramedullary Disease in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma From the Pooled LocoMMotion and MoMMent Studies, Clinical Lymphoma, Myeloma and Leukemia,

Philippe Moreau 等，来自汇总的 LocoMMotion 和 MoMMent 研究中三类药物暴露后复发/难治性多发性骨髓瘤伴髓外病变患者的结局，临床淋巴瘤、骨髓瘤和白血病，

https://doi.org/10.1016/j.clml.2025.03

。

Kumar, S., et al. Phase 2 Study of Talquetamab + Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma and Extramedullary Disease: RedirecTT-1. 2025 European Hematology Association Congress.

Kumar, S. 等。Talquetamab + Teclistamab 在复发/难治性多发性骨髓瘤和髓外病变患者中的二期研究：RedirecTT-1。2025年欧洲血液学协会大会。

June 2025

2025年6月

。

TALVEY

塔尔维

U.S. Prescribing Information,

美国处方信息，

August 2023

2023年8月

。

European Medicines Agency. TALVEY Summary of Product Characteristics.

欧洲药品管理局。TALVEY产品特性摘要。

August 2023

2023年8月

。

U.S. FDA Approves TECVAYLI

美国食品药品监督管理局批准了TECVAYLI

(teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma.

（teclistamab-cqyv），首个用于治疗复发或难治性多发性骨髓瘤患者的双特异性T细胞衔接抗体。

https://www.jnj.com/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma. Accessed

https://www.jnj.com/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma. 已访问

May 2025

2025年5月

。

Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(5):548-5672020;95(5):548-567.

Rajkumar SV。多发性骨髓瘤：2020年关于诊断、风险分层和管理的更新。《美国血液学杂志》。2020；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

. 已访问

November 2024

2024年11月

。

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

. 已访问

November 2024

2024年11月

。

American Cancer Society. Key Statistics About Multiple Myeloma.

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

https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=多发性骨髓瘤是一种相对少见的癌症，预计2023年美国将有17,600例男性和15,370例女性确诊。

. Accessed

. 已访问

November 2024

2024年11月

。

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

SEER浏览器：一个用于SEER癌症统计数据的交互式网站 [互联网]. 监测研究计划，国家癌症研究所。

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

. Accessed

. 已访问

November 2024