HORSHAM, Pa., Feb. 20, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TECVAYLI® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR) or better for a minimum of six months.1 There is a continued unmet need for patients with multiple myeloma and this approval allows increased flexibility in dosing schedule for appropriate patients with a weight-based regimen..

HORSHAM，Pa.，2024年2月20日/PRNewswire/--强生公司今天宣布，美国食品和药物管理局（FDA）已批准TECVAYLI®（teclistamab cqyv）的补充生物制剂许可证申请（sBLA），用于复发或难治性多发性骨髓瘤（RRMM）患者每两周（Q2W）减少1.5 mg/kg的给药频率他们已经达到并维持了至少六个月的完全缓解（CR）或更好。多发性骨髓瘤患者的需求仍然没有得到满足，这一批准使得适当的基于体重的患者的给药时间表更加灵活。

TECVAYLI®, which is administered subcutaneously, was the first bispecific antibody targeting B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T-cells to activate an immune response.2 TECVAYLI® was approved in October 2022 for the treatment of adult patients with RRMM who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.2 This indication is approved under accelerated approval based on response rate.

皮下注射的TECVAYLI®是第一种针对多发性骨髓瘤细胞上的B细胞成熟抗原（BCMA）和T细胞上的CD3以激活免疫应答的双特异性抗体。TECVAYLI®于2022年10月被批准用于治疗成年RRMM患者，这些患者至少接受过四种治疗方案，包括蛋白酶体抑制剂，一种免疫调节药物和一种抗CD38单克隆抗体。2这种适应症是根据反应率加速批准的。

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. TECVAYLI® has been prescribed to more than 3,600 patients in the U.S. since approval.3.

继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。自批准以来，TECVAYLI®已在美国为3600多名患者开出处方。

This approval is based on results from the Phase 1/2 MajesTEC-1 study (Phase 1: NCT03145181; Phase 2: NCT04557098). In the Phase 1/2 MajesTEC-1 study, patients were initially treated with the recommended Phase 2 dose (RP2D) of 1.5 mg/kg TECVAYLI® weekly (QW) administered subcutaneously.4 Patients who achieved a confirmed CR or better for six months or longer (Phase 2), were eligible to reduce dosing frequency to 1.5 mg/kg Q2W until disease progression or unacceptable toxicity.1,4.

该批准基于1/2期MajesTEC-1研究（第一阶段：NCT03145181；第二阶段：NCT04557098）的结果。在1/2期MajesTEC-1研究中，患者最初接受皮下注射推荐的2期剂量（RP2D），每周1.5 mg/kg TECVAYLI®（QW）。4获得确诊CR或更好的患者6个月或更长时间（第2阶段），有资格将给药频率降低至1.5 mg/kg Q2W，直到疾病进展或不可接受的毒性[1,4]。

'TECVAYLI is the only BCMA-targeted immune-based therapy with weight-based dosing. Today's approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules,' said Rachel Kobos, M.D., Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine.

“TECVAYLI是唯一一种基于体重的BCMA靶向免疫疗法。强生创新医学公司肿瘤学研究与开发副总裁医学博士雷切尔·科博斯（RachelKobos）说，今天批准对符合条件的患者每两周给药一次，这将进一步使临床医生能够满足可能需要灵活给药时间表的患者的个人需求。

'As the first bispecific approved for the treatment of multiple myeloma, combined with the longest in-market experience by physicians, TECVAYLI is another example of our commitment to pioneering cutting-edge research to help improve outcomes for patients with multiple myeloma.'.

“作为第一个被批准用于治疗多发性骨髓瘤的双特异性药物，加上医生最长的市场经验，TECVAYLI是我们致力于开创前沿研究以帮助改善多发性骨髓瘤患者预后的另一个例子。”

About the MajesTEC-1 Study

关于MajesTEC-1研究

MajesTEC-1 (NCT03145181, NCT04557098), is a Phase 1/2 single-arm, open-label, multicohort, multicenter dose-escalation study to evaluate the safety and efficacy of teclistamab in adults with RRMM who received three or more prior lines of therapy (n=165).5,6

MajesTEC-1（NCT03145181，NCT04557098）是一项1/2期单臂，开放标签，多中心，多中心剂量递增研究，用于评估替克利单抗在接受三种或更多种先前治疗方案的RRMM成人中的安全性和有效性（n=165）

Phase 1 of the study (NCT03145181) was conducted in two parts: dose escalation (Part 1) and dose expansion (Part 2).6 It evaluated safety, tolerability, pharmacokinetics, and preliminary efficacy of teclistamab in adult participants with RRMM.6 Phase 2 of the study (NCT04557098) evaluated the efficacy of teclistamab at the RP2D, established at subcutaneous 1.5 mg/kg weekly, as measured by ORR.5.

该研究的第一阶段（NCT03145181）分为两部分进行：剂量递增（第1部分）和剂量扩展（第2部分）[6]。它评估了替克利单抗在RRMM成年参与者中的安全性，耐受性，药代动力学和初步疗效。研究的第二阶段（NCT04557098）评估了替克利单抗在RP2D的疗效，通过ORR测量，每周皮下注射1.5 mg/kg。

TECVAYLI® IMPORTANT SAFETY INFORMATION

TECVAYLI®重要安全信息

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI®. Initiate treatment with TECVAYLI® step-up dosing schedule to reduce risk of CRS.

警告：接受TECVAYLI®治疗的患者可能会发生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细胞因子释放综合征（CRS），包括危及生命或致命的反应。开始使用TECVAYLI®递增剂量计划进行治疗，以降低CRS的风险。

Withhold TECVAYLI® until CRS resolves or permanently discontinue based on severity. Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and life-threatening reactions, can occur in patients receiving TECVAYLI®. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment.

扣留TECVAYLI®直到CRS解决或根据严重程度永久停止。接受TECVAYLI®治疗的患者可能会发生神经毒性，包括免疫效应细胞相关神经毒性综合征（ICANS）以及严重且危及生命的反应。在治疗期间监测患者的神经系统毒性体征或症状，包括ICAN。

Withhold TECVAYLI® until neurologic toxicity resolves or permanently discontinue based on severity. TECVAYLI® is available only through a restricted program called the TECVAYLI® and TALVEY™ Risk Evaluation and Mitigation Strategy (REMS). .

扣留TECVAYLI®直到神经毒性消退或根据严重程度永久停止。TECVAYLI®只能通过一项名为TECVAYLI®和TALVEY™风险评估和缓解策略（REMS）的受限计划获得。

INDICATION AND USAGE

适应症和用法

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..

TECVAYLI®（teclistamab cqyv）是一种双特异性B细胞成熟抗原（BCMA）定向的CD3 T细胞接受者，用于治疗复发或难治性多发性骨髓瘤的成年患者，这些患者至少接受过四种治疗方案，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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

根据回复率，该适应症在加速批准下获得批准。继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。

WARNINGS AND PRECAUTIONS

警告和注意事项

Cytokine Release Syndrome - TECVAYLI® 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® at the recommended dose, with Grade 1 CRS occurring in 50% of patients, Grade 2 in 21%, and Grade 3 in 0.6%.

细胞因子释放综合征-TECVAYLI®可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%接受推荐剂量TECVAYLI®的患者发生CRS，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。

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®. 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.

33%的患者发生复发性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。在随后剂量的TECVAYLI®后，不到3%的患者首次发生CRS。CRS发作的中位时间为最近一次剂量后2（范围：1至6）天，中位持续时间为2（范围：1至9）天。

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)..

CRS的临床体征和症状包括但不限于发烧，缺氧，寒战，低血压，窦性心动过速，头痛和肝酶升高（天冬氨酸转氨酶和丙氨酸转氨酶升高）。

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

根据TECVAYLI®加速给药时间表开始治疗，以降低CRS的风险。服用预处理药物以降低CRS的风险，并相应地监测服用TECVAYLI®后的患者。在CRS的第一个迹象时，立即评估患者的住院情况。根据严重程度管理支持性护理，并根据当前的实践指南考虑进一步管理。

Withhold or permanently discontinue TECVAYLI® based on severity..

根据严重程度扣留或永久停用TECVAYLI®。

TECVAYLI® is available only through a restricted program under a REMS.

TECVAYLI®只能通过REMS下的受限程序获得。

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

神经系统毒性，包括 ICANS - TECVAYLI® 可导致严重或危及生命的神经系统毒性，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® 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%).

在临床试验中，57%接受推荐剂量TECVAYLI®治疗的患者发生神经系统毒性，2.4%的患者发生3级或4级神经系统毒性。最常见的神经系统毒性是头痛（25%），运动功能障碍（16%），感觉神经病（15%）和脑病（13%）。

With longer follow-up, Grade 4 seizure and fatal Guillain-Barré syndrome (one patient each) occurred in patients who received TECVAYLI®..

随着随访时间的延长，接受TECVAYLI®治疗的患者发生了4级癫痫发作和致命的格林-巴利综合征（各一名患者）。

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

在临床试验中，6%接受推荐剂量TECVAYLI®治疗的患者报告了ICAN。复发性ICAN发生在1.8%的患者中。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ICAN。随后服用TECVAYLI®后，不到3%的患者首次出现ICAN。

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发病的中位时间为最近一次剂量后4（范围：2至8）天，中位持续时间为3（范围：1至20）天。据报道，ICAN最常见的临床表现是混乱状态和书写困难。在CRS解决后或在没有CRS的情况下，ICAN的发作可以与CRS同时发生。

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

在治疗期间监测患者的神经毒性体征和症状。在出现包括ICAN在内的神经系统毒性的第一个迹象时，立即评估患者并根据严重程度提供支持治疗。根据建议的严重程度，扣留或永久停用TECVAYLI®，并考虑根据现行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® step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves..

由于可能出现神经系统毒性，患者有可能出现意识障碍。建议患者在 TECVAYLI® 增量给药期间和给药后 48 小时内，以及在新出现任何神经系统毒性症状时，避免驾驶或操作重型或具有潜在危险性的机械，直至神经系统毒性症状缓解。

TECVAYLI® is available only through a restricted program under a REMS.

TECVAYLI®只能通过REMS下的受限程序获得。

TECVAYLI® and TALVEY™ REMS - TECVAYLI® is available only through a restricted program under a REMS called the TECVAYLI® and TALVEY™ REMS because of the risks of CRS and neurologic toxicity, including ICANS.

TECVAYLI®和TALVEY™REMS-由于CRS和神经系统毒性（包括ICAN）的风险，TECVAYLI®只能通过称为TECVAYLI®和TALVEY™REMS的REMS下的受限程序获得。

Hepatotoxicity - TECVAYLI® can cause hepatotoxicity, including fatalities. In patients who received TECVAYLI® 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%.

肝毒性-TECVAYLI®可引起肝毒性，包括死亡。在临床试验中以推荐剂量接受TECVAYLI®治疗的患者中，有一例致命的肝衰竭病例。34%的患者发生天冬氨酸转氨酶（AST）升高，3级或4级升高1.2%。

Elevated alanine aminotransferase (ALT) occurred in 28% of patients, with Grade 3 or 4 elevations in 1.8%. 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..

28%的患者出现丙氨酸氨基转移酶（ALT）升高，其中 1.8%出现 3 级或 4 级升高。6%的患者出现总胆红素升高，其中 0.6% 出现 3 级或 4 级升高。肝酶升高可发生在并发或不并发 CRS 的情况下。

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI® or consider permanent discontinuation of TECVAYLI® based on severity.

根据临床指示，在基线和治疗期间监测肝酶和胆红素。扣留TECVAYLI®或根据严重程度考虑永久停用TECVAYLI®。

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

感染-TECVAYLI®可导致严重、危及生命或致命的感染。在临床试验中以推荐剂量接受TECVAYLI®治疗的患者中，30%的患者发生严重感染，包括机会性感染，3级或4级感染占35%，致命感染占4.2%。

Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI® and treat appropriately. Administer prophylactic antimicrobials according to guidelines. Withhold TECVAYLI® or consider permanent discontinuation of TECVAYLI® based on severity..

在使用TECVAYLI®治疗之前和期间监测患者的感染体征和症状，并进行适当治疗。根据指南服用预防性抗菌药物。扣留TECVAYLI®或根据严重程度考虑永久停用TECVAYLI®。

Monitor immunoglobulin levels during treatment with TECVAYLI® and treat according to guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

在使用 TECVAYLI® 治疗期间，监测免疫球蛋白水平，并根据指南进行治疗，包括感染预防措施和抗生素或抗病毒预防措施。

Neutropenia - TECVAYLI® can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI® 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.

中性粒细胞减少症--TECVAYLI®可导致中性粒细胞减少症和发热性中性粒细胞减少症。在临床试验中，按推荐剂量接受TECVAYLI®治疗的患者中，84%的患者出现中性粒细胞减少，56%的患者出现3级或4级中性粒细胞减少。3%的患者出现了发热性中性粒细胞减少症。

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® based on severity.

在基线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。根据严重程度扣留TECVAYLI®。

Hypersensitivity and Other Administration Reactions - TECVAYLI® can cause both systemic administration-related and local injection-site reactions. Systemic Reactions - In patients who received TECVAYLI® 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.

超敏反应和其他给药反应-TECVAYLI®可引起全身给药相关和局部注射部位反应。全身反应-在临床试验中以推荐剂量接受TECVAYLI®治疗的患者中，1.2%的患者出现全身给药反应，包括1级复发性发热和1级舌头肿胀。

Local Reactions - In patients who received TECVAYLI® 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® or consider permanent discontinuation of TECVAYLI® based on severity..

局部反应-在临床试验中以推荐剂量接受TECVAYLI®的患者中，35%的患者发生注射部位反应，1级注射部位反应为30%，2级为4.8%。扣留TECVAYLI®或根据严重程度考虑永久停用TECVAYLI®。

Embryo-Fetal Toxicity - Based on its mechanism of action, TECVAYLI® 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 TECVAYLI® and for 5 months after the last dose..

胚胎-胎儿毒性-根据其作用机制，TECVAYLI®给孕妇服用时可能会造成胎儿伤害。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®治疗期间和最后一剂后5个月内使用有效的避孕措施。

About TECVAYLI®

关于TECWAYLI®

TECVAYLI® (teclistamab-cqyv) received approval from the U.S. FDA in October 2022 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.2 The European Commission (EC) granted TECVAYLI® conditional marketing authorization (CMA) in August 2022 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.

TECVAYLI®（teclistamab cqyv）于2022年10月获得美国FDA的批准，作为一种现成（或即用）抗体，用于皮下治疗复发或难治性多发性骨髓瘤（RRMM）的成年患者，这些患者至少接受过四种治疗方案，包括蛋白酶体抑制剂，一种免疫调节剂和一种抗CD38抗体。2欧盟委员会（EC）于2022年8月授予TECVAYLI®条件性营销授权（CMA），作为单一疗法，用于治疗至少接受过三种治疗的成年RRMM患者，包括蛋白酶体抑制剂，免疫调节剂和抗CD38抗体，自上次治疗以来，已经证明了疾病的进展。

In August 2023, the EC granted the approval of a Type II variation application for TECVAYLI®, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. 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..

2023年8月，欧盟委员会批准了TECVAYLI®的II型变异申请，为达到完全缓解（CR）或更好至少六个月的患者提供了每两周减少1.5 mg/kg给药频率的选择。TECVAYLI®是一种一流的双特异性T细胞参与者抗体疗法，它利用创新科学通过与T细胞表面表达的CD3受体和多发性骨髓瘤细胞表面表达的B细胞成熟抗原（BCMA）结合来激活免疫系统。和一些健康的B系细胞。

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.7 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.8 Multiple myeloma is the third most common blood cancer worldwide and remains an incurable disease.9 In 2024, it was estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S.

多发性骨髓瘤是一种无法治愈的血癌，会影响一种称为浆细胞的白细胞，这种白细胞存在于骨髓中。7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。8多发性骨髓瘤是全球第三大常见血癌，仍然是一种无法治愈的疾病。9 2024年，据估计，美国将有超过35000人被诊断出患有多发性骨髓瘤。

and more than 12,000 people would die from the disease.10 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.12,13.

超过12000人将死于这种疾病。10名多发性骨髓瘤患者的5年生存率为59.8%。11虽然一些被诊断为多发性骨髓瘤的患者最初没有症状，但大多数患者被诊断出的症状可能包括骨折或疼痛，红细胞计数低，疲劳，高钙水平和肾脏问题或感染12,13。

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.

    在强生公司，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有能力建立一个能够预防、治疗和治愈复杂疾病的世界，在这个世界里，治疗更智能，创伤更小，解决方案更个性化。通过我们在创新医学和医疗技术领域的专业知识，我们处于独特的地位，能够在当今医疗保健解决方案的各个领域进行创新，实现未来的突破，并对人类健康产生深远影响。