美国FDA肿瘤药物咨询委员会投票支持DARZALEX FASPRO®用于治疗高危冒烟型多发性骨髓瘤的获益风险概况-动脉网

U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma

强生等信源发布 2025-05-20 10:38

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可切换为仅中文







ODAC recommendation based on the positive progression-free survival and clinical benefit in the Phase 3 AQUILA study

基于第3阶段AQUILA研究中无进展生存期和临床益处的积极结果，ODAC给出了推荐。

If approved, DARZALEX FASPRO

如果获得批准，DARZALEX FASPRO

would be the first treatment to potentially delay or

将是首个可能延缓或

prevent progression to multiple myeloma

预防进展为多发性骨髓瘤

RARITAN, N.J.

拉里坦，新泽西州

，

May 20, 2025

2025年5月20日

/PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted (6-2) in favor of the benefit-risk profile of single-agent DARZALEX

/PRNewswire/ -- 约翰逊公司（纽约证券交易所代码：JNJ）今天宣布，美国食品药品监督管理局（FDA）肿瘤药物咨询委员会（ODAC）以6比2的投票结果支持了单药DARZALEX的获益风险概况。

FASPRO

法斯普罗

(daratumumab and hyaluronidase-fihj) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). An application for the approval of DARZALEX

（达拉图单抗和透明质酸酶-fihj）用于治疗高风险隐匿性多发性骨髓瘤（HR-SMM）的成年患者。已提交达拉图单抗的批准申请。

FASPRO

for adult patients with HR-SMM was

对于患有HR-SMM的成年患者

submitted

已提交

to the FDA in November 2024.

2024年11月提交给美国食品药品监督管理局（FDA）。

The vote highlights a pivotal moment in the care of patients most likely to develop active multiple myeloma (MM), potentially altering the course of disease and treatment. DARZALEX

该投票凸显了最有可能发展为活动性多发性骨髓瘤（MM）患者护理中的一个关键时刻，可能会改变疾病和治疗的进程。 DARZALEX

FASPRO

法斯普罗

is a foundational therapy in MM, and if approved in this indication, would provide a potential path for earlier intervention.

是多发性骨髓瘤（MM）的基础治疗，如果在此适应症中获得批准，将为更早的干预提供潜在途径。

No treatments are approved specifically to treat HR-SMM. In 2024, it was estimated that more than 35,000 people would be diagnosed with MM in the U.S., and approximately 15 percent of newly diagnosed MM cases are classified as smoldering. While patients diagnosed with HR-SMM are asymptomatic, approximately 50 percent are likely to develop active disease within two to three years.

目前尚无专门批准用于治疗高风险冒烟型多发性骨髓瘤（HR-SMM）的疗法。据2024年估计，美国将有超过35,000人被诊断为多发性骨髓瘤（MM），其中约15%的新诊断病例被归类为冒烟型。尽管被诊断为高风险冒烟型多发性骨髓瘤的患者无症状，但大约50%的患者可能在两到三年内发展为活动性疾病。

The current standard of care (SOC) for smoldering multiple myeloma (SMM), even those considered high-risk, is active monitoring ('Watch and Wait') until progression, which may lead to therapeutic intervention only after the detection of end-organ damage..

目前冒烟型多发性骨髓瘤（SMM）的标准治疗（SOC），即使是那些被认为是高风险的患者，也是在进展前进行积极监测（“观察和等待”），这可能仅在检测到终末器官损伤后才导致治疗干预。

'Early intervention in high-risk smoldering multiple myeloma demonstrated a reduction in the risk of progression or death,' said Sen Zhuang, M.D., Vice President, Oncology Clinical Research, Johnson & Johnson Innovative Medicine. 'The proactive approach demonstrated in the AQUILA study is an example of Johnson & Johnson's aspiration to get in front of cancer by providing a platform to treat disease before progression to active disease.'.

“早期干预高危冒烟型多发性骨髓瘤显示出降低疾病进展或死亡风险的效果，”杨森制药肿瘤临床研究副总裁朱晟（Sen Zhuang）博士表示，“AQUILA 研究中展现的前瞻性方法是强生致力于通过提供在疾病进展为活动性疾病之前进行治疗的平台，来领先于癌症的一个例子。”

The committee reviewed data from the AQUILA study, a Phase 3, randomized, open-label trial which evaluated the efficacy and safety of DARZALEX

委员会审查了AQUILA研究的数据，这是一项三期、随机、开放标签的试验，评估了DARZALEX的有效性和安全性。

FASPRO

法斯普罗

versus SOC active monitoring in patients with HR-SMM.

与SOC主动监测相比，在HR-SMM患者中。

Results were initially

结果最初

presented

展示

at the 2024 American Society of Hematology (ASH) Annual Meeting and simultaneously

在2024年美国血液学会（ASH）年会上同时进行

published

已发布

在

The New England Journal of Medicine.

《新英格兰医学杂志》。

'High-risk smoldering multiple myeloma remains a challenging clinical conundrum with no approved therapies, and earlier intervention may delay or even prevent progression to active multiple myeloma,' said Peter Voorhees, M.D., Atrium Health / Levine Cancer Institute, Charlotte, N.C.‡ 'We appreciate the balance the committee provided when assessing the risks and benefits of finite treatment at this stage and its recognition of the promise of DARZALEX .

“高危冒烟型多发性骨髓瘤仍然是一个具有挑战性的临床难题，目前尚无获批的疗法，而早期干预可能会延迟甚至预防进展为活动性多发性骨髓瘤，”北卡罗来纳州夏洛特市Atrium Health / Levine癌症研究所的彼得·沃赫斯博士表示。 “我们赞赏委员会在评估此阶段有限治疗的风险和益处时所作出的平衡，并认可DARZALEX的潜力。”

FASPRO

法斯普罗

。'

The recommendation reinforces Johnson & Johnson's vision for the future of oncology – one where early diagnosis and treatments become standard, and where science moves us closer to a world without cancer. With bold choices over time, J&J is dedicated to our mission of evolving the treatment paradigm of patients with multiple myeloma..

该建议重申了强生公司对未来肿瘤学的愿景——早期诊断和治疗成为标准，科学使我们更接近一个没有癌症的世界。通过长期的大胆选择，强生致力于改变多发性骨髓瘤患者的治疗模式。

The ODAC is convened upon request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of oncologic diseases. The committee provides non-binding recommendations based on its evaluation; however, final decisions on approval of the drug are made by the FDA..

ODAC应FDA的要求召开会议，审查和评估用于治疗肿瘤疾病的人类药物产品的安全性和有效性数据。委员会根据其评估提供非约束性的建议；然而，药物的最终批准决定由FDA做出。

About the AQUILA Study

关于AQUILA研究

AQUILA (

NCT03301220

) is a randomized, multicenter Phase 3 study comparing treatment with DARZALEX

）是一项随机、多中心的三期研究，比较了DARZALEX的治疗效果

FASPRO

to active monitoring in patients with smoldering multiple myeloma (SMM). The primary endpoint is progression-free survival (PFS), defined as progression to active multiple myeloma (MM) as assessed by an independent review committee, according to IMWG diagnostic criteria for MM (SLiM-CRAB), or death.

对于冒烟型多发性骨髓瘤（SMM）患者，转为积极监测。主要终点是无进展生存期（PFS），定义为根据IMWG多发性骨髓瘤（MM）诊断标准（SLiM-CRAB），由独立审查委员会评估的进展为活动性多发性骨髓瘤（MM）或死亡。

Major secondary endpoints included overall response rate, PFS on first-line MM treatment (PFS2), and overall survival. .

主要的次要终点包括总体反应率、一线MM治疗的无进展生存期（PFS2）和总生存期。

About Multiple Myeloma

关于多发性骨髓瘤

Multiple myeloma is a 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影响浆细胞的血液癌症，浆细胞是一种存在于骨髓中的白细胞。

In multiple myeloma, these malignant plasma cells proliferate and replace normal cells in the bone marrow.

在多发性骨髓瘤中，这些恶性的浆细胞增殖并取代骨髓中的正常细胞。

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

多发性骨髓瘤是全球第二常见的血液癌症，仍然是一种无法治愈的疾病。

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

据估计，2024年美国将有超过35,000人被诊断出患有多发性骨髓瘤，超过12,000人将死于该疾病。

People with multiple myeloma have a 5-year survival rate of 59.8 percent. 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, kidney problems or infections..

多发性骨髓瘤患者的五年生存率为 59.8%。虽然有些被诊断为多发性骨髓瘤的人最初没有症状，但大多数患者因可能出现的症状而被诊断出来，这些症状包括骨折或疼痛、红细胞计数低、疲倦、高钙水平、肾脏问题或感染等。

7,8

About Smoldering Multiple Myeloma

关于冒烟型多发性骨髓瘤

Smoldering multiple myeloma (SMM) is an asymptomatic intermediate disease state of multiple myeloma characterized by abnormal monoclonal bone marrow plasma cell (BMPC) proliferation and abnormally high levels of circulating M proteins with absence of myeloma-defining events. SMM is associated with a 10 percent annual risk of progressing to multiple myeloma (MM) or a related disorder, but half of patients with high-risk SMM progress to MM and are at risk of developing severe symptoms and organ damage within just two years of diagnosis..

冒烟型多发性骨髓瘤（SMM）是一种无症状的多发性骨髓瘤中间状态，其特征为单克隆骨髓浆细胞（BMPC）异常增殖和循环中M蛋白水平异常升高，但无骨髓瘤定义的相关事件。SMM每年有10%的风险进展为多发性骨髓瘤（MM）或相关疾病，但高危SMM患者中有一半会进展为MM，并可能在诊断后两年内出现严重症状和器官损害。

About DARZALEX

关于DARZALEX

FASPRO

法斯普罗

and DARZALEX

和DARZALEX

DARZALEX

达雷木单抗

FASPRO

法斯普罗

(daratumumab and hyaluronidase-fihj)

（达拉图单抗和透明质酸酶-fihj）

received

收到

U.S. FDA approval in May 2020 and is approved for nine indications in MM, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.

美国FDA于2020年5月批准，适用于多发性骨髓瘤（MM）的九种适应症，其中四种用于适合或不适合移植的新诊断患者的前线治疗。

3,6

It is the only subcutaneous CD38-directed antibody approved to treat patients with MM. DARZALEX

它是唯一被批准用于治疗多发性骨髓瘤（MM）患者的皮下CD38导向抗体。DARZALEX

FASPRO

法斯普罗

is co-formulated with recombinant human hyaluronidase PH20, Halozyme's ENHANZE

与重组人透明质酸酶PH20（Halozyme的ENHANZE技术）共同配制

drug delivery technology.

药物递送技术。

DARZALEX

达雷木单抗

(daratumumab) received

（达拉图单抗）已收到

U.S. FDA approval

美国食品药品监督管理局批准

in November 2015 and is approved in eight indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant eligible and ineligible.

在2015年11月，并在八个适应症中获得批准，其中三个是一线治疗，包括新诊断的适合移植和不适合移植的患者。

DARZALEX

达雷木单抗

is the first CD38-directed antibody approved to treat MM.

是首个获批治疗MM的CD38导向抗体。

DARZALEX

达雷木单抗

-based regimens have been used in the treatment of more than 618,000 patients worldwide.

基于这些方案的治疗已经在全球范围内用于超过618,000名患者。

在

August 2012

2012年8月

, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab.

杨森生物技术公司和Genmab A/S签署了一项全球协议，根据该协议，杨森获得了开发、生产和商业化达拉图单抗的独家许可。

For more information, visit

欲了解更多信息，请访问

https://www.darzalexhcp.com.

DARZALEX

达雷木单抗

FASPRO

法斯普罗

INDICATIONS AND IMPORTANT SAFETY INFORMATION

适应症和重要安全信息

INDICATIONS

适应症

DARZALEX

达雷木单抗

FASPRO

(daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with MM:

（达拉图单抗和透明质酸酶-fihj）适用于治疗成年MM患者：

In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant

与硼替佐米、来那度胺和地塞米松联合用于新诊断的适合自体干细胞移植的患者的诱导和巩固治疗

In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant

与硼替佐米、马法兰和泼尼松联合用于新诊断的不符合自体干细胞移植条件的患者

In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory MM who have received at least one prior therapy

与来那度胺和地塞米松联合用于新诊断的不符合自体干细胞移植条件的患者，以及至少接受过一种先前治疗的复发或难治性多发性骨髓瘤（MM）患者。

In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant

与硼替佐米、沙利度胺和地塞米松联合用于新诊断的适合自体干细胞移植的患者

In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (PI)

与泊马度胺和地塞米松联合用于既往至少接受过一种治疗方案（包括来那度胺和蛋白酶体抑制剂（PI））的患者。

In combination with carfilzomib and dexamethasone in patients with relapsed or refractory MM who have received one to three prior lines of therapy

与卡非佐米和地塞米松联合用于接受过一到三线治疗的复发性或难治性MM患者

In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy

与硼替佐米和地塞米松联合用于已接受至少一种先前治疗的患者

As monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent

作为单药治疗，用于已接受过至少三线既往治疗（包括一种蛋白酶抑制剂和一种免疫调节剂）或对一种蛋白酶抑制剂和一种免疫调节剂双重耐药的患者。

IMPORTANT SAFETY INFORMATION

重要安全信息

CONTRAINDICATIONS

禁忌症

DARZALEX

达雷木单抗

FASPRO

is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase or any of the components of the formulation.

对达雷妥尤单抗、透明质酸酶或制剂中任何成分有严重过敏史的患者禁用。

WARNINGS AND PRECAUTIONS

警告和注意事项

Hypersensitivity and Other Administration Reactions

超敏反应及其他管理反应

Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX

DARZALEX 可能引起全身性给药相关反应（包括严重或危及生命的反应）以及局部注射部位反应。

FASPRO

法斯普罗

. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX

含有达拉图单抗的产品，包括DARZALEX，已有致死性反应的报告。

FASPRO

法斯普罗

。

Systemic Reactions

全身反应

In a pooled safety population of 1249 patients with MM (N=1056) or light chain (AL) amyloidosis (N=193) who received DARZALEX

在1249名接受DARZALEX治疗的MM（N=1056）或轻链（AL）淀粉样变性（N=193）患者的安全性汇总人群中

FASPRO

as monotherapy or in combination, 7 percent of patients experienced a systemic administration-related reaction (Grade 2: 3.2 percent, Grade 3: 0.7 percent, Grade 4: 0.1 percent). Systemic administration-related reactions occurred in 7 of patients with the first injection, 0.2 percent with the second injection, and cumulatively 1 percent with subsequent injections.

作为单一疗法或联合治疗时，7%的患者出现了与系统给药相关的反应（2级：3.2%，3级：0.7%，4级：0.1%）。首次注射后有7%的患者出现系统给药相关反应，第二次注射为0.2%，后续注射累计为1%。

The median time to onset was 2.9 hours (range: 5 minutes to 3.5 days). Of the 165 systemic administration-related reactions that occurred in 93 patients, 144 (87 percent) occurred on the day of DARZALEX .

中位发病时间为2.9小时（范围：5分钟至3.5天）。在93名患者中发生的165次与全身给药相关的反应中，有144次（87%）发生在使用DARZALEX的当天。

FASPRO

法斯普罗

administration. Delayed systemic administration-related reactions have occurred in 1 percent of the patients.

管理。1%的患者出现了与延迟系统管理相关的反应。

Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision. .

严重反应包括低氧血症、呼吸困难、高血压、心动过速和眼部不良反应，包括脉络膜渗漏、急性近视和急性闭角型青光眼。其他与系统性给药相关反应的体征和症状可能包括呼吸道症状，如支气管痉挛、鼻塞、咳嗽、喉咙刺激、过敏性鼻炎和喘息，以及过敏反应、发热、胸痛、瘙痒、寒战、呕吐、恶心、低血压和视力模糊。

Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX .

预先用组胺-1受体拮抗剂、对乙酰氨基酚和皮质类固醇对患者进行药物治疗。监测患者是否出现与全身给药相关的反应，尤其是在第一次和第二次注射后。对于过敏反应或危及生命（4级）的给药相关反应，应立即并永久停止使用DARZALEX。

FASPRO

法斯普罗

. Consider administering corticosteroids and other medications after the administration of DARZALEX

在使用DARZALEX后，考虑给予皮质类固醇和其他药物。

FASPRO

depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions.

根据剂量方案和病史，尽量减少延迟（定义为发生在给药后第二天）的系统性给药相关反应的风险。

Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX

包含达拉图单抗的产品可能会导致眼部不良反应，包括因睫状体脉络膜渗出引起的急性近视和前房角狭窄，有可能增加眼内压或导致青光眼。如果出现眼部症状，应中断使用DARZALEX。

FASPRO

法斯普罗

and seek immediate ophthalmologic evaluation prior to restarting DARZALEX

在重新开始使用DARZALEX之前，应立即寻求眼科评估。

FASPRO

法斯普罗

。

Local Reactions

局部反应

In this pooled safety population, injection-site reactions occurred in 7 percent of patients, including Grade 2 reactions in 0.8 percent. The most frequent (>1 percent) injection-site reaction was injection-site erythema. These local reactions occurred a median of 5 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX .

在这一汇总安全人群中，7%的患者发生了注射部位反应，其中0.8%为2级反应。最常见的（>1%）注射部位反应是注射部位红斑。这些局部反应在开始给予DARZALEX后中位5分钟（范围：0分钟至6.5天）发生。

FASPRO

. Monitor for local reactions and consider symptomatic management.

监测局部反应，并考虑对症处理。

Neutropenia

中性粒细胞减少症

Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX

达雷妥尤单抗可能会增加背景治疗引起的中性粒细胞减少。根据背景治疗的制造商处方信息，在治疗期间定期监测全血细胞计数。监测中性粒细胞减少患者的感染迹象。考虑暂停DARZALEX。

FASPRO

法斯普罗

until recovery of neutrophils. In lower body weight patients receiving DARZALEX

直到中性粒细胞恢复。在体重较低的患者接受DARZALEX时

FASPRO

法斯普罗

, higher rates of Grade 3-4 neutropenia were observed.

，观察到较高的 3-4 级中性粒细胞减少症发生率。

Thrombocytopenia

血小板减少症

Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX

达雷妥尤单抗可能会增加背景治疗引起的血小板减少症。根据背景疗法生产商的处方信息，在治疗期间定期监测全血细胞计数。考虑暂停使用DARZALEX。

FASPRO

法斯普罗

until recovery of platelets.

直到血小板恢复。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

Based on the mechanism of action, DARZALEX

基于作用机制，DARZALEX

FASPRO

法斯普罗

can cause fetal harm when administered to a pregnant woman. DARZALEX

当给孕妇服用时，可能会对胎儿造成伤害。DARZALEX

FASPRO

法斯普罗

may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX

可能导致胎儿免疫细胞耗竭和骨密度降低。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DARZALEX治疗期间采取有效的避孕措施。

FASPRO

and for 3 months after the last dose.

并且在最后一剂后的3个月内。

The combination of DARZALEX

DARZALEX的组合

FASPRO

法斯普罗

with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy.

与来那度胺、沙利度胺或泊马度胺合用在孕妇中是禁忌的，因为来那度胺、沙利度胺和泊马度胺可能导致出生缺陷和未出生婴儿的死亡。有关妊娠期间使用的更多信息，请参阅来那度胺、沙利度胺或泊马度胺的处方信息。

Interference With Serological Testing

血清学检测的干扰

Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum.

达雷妥尤单抗与红细胞（RBCs）上的CD38结合，导致间接抗球蛋白试验（间接Coombs试验）呈阳性。达雷妥尤单抗介导的间接抗球蛋白试验阳性可能在最后一次达雷妥尤单抗给药后持续长达6个月。结合到达雷妥尤单抗上的红细胞会掩盖患者血清中对次要抗原的抗体检测。

The determination of a patient's ABO and Rh blood type are not impacted. .

患者的ABO和Rh血型的测定不受影响。

Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX

通知血清检测中心有关干扰情况，并告知血库患者已接受DARZALEX治疗。

FASPRO

法斯普罗

. Type and screen patients prior to starting DARZALEX

在开始使用DARZALEX之前，对患者进行分型和筛查

FASPRO

。

Interference With Determination of Complete Response

对完全缓解判定的干扰

Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX .

达雷妥尤单抗是一种人类免疫球蛋白 G (IgG) kappa 单克隆抗体，在用于监测内源性 M 蛋白的血清蛋白电泳 (SPE) 和免疫固定电泳 (IFE) 测定中均可被检测到。这种干扰可能会影响某些 DARZALEX 患者完全缓解和疾病进展的判定。

FASPRO

法斯普罗

-treated patients with IgG kappa myeloma protein.

- 治疗了具有IgG kappa型骨髓瘤蛋白的患者。

ADVERSE REACTIONS

不良反应

In MM, the most common adverse reaction (≥20 percent) with DARZALEX

在MM中，使用DARZALEX最常见的不良反应（≥20％）是

FASPRO

monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20 percent for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, upper respiratory tract infection, peripheral sensory neuropathy, constipation, pneumonia, and peripheral edema. .

单药治疗最常见的不良反应是上呼吸道感染。联合治疗（任何组合≥20％）最常见的不良反应包括疲劳、恶心、腹泻、呼吸困难、失眠、头痛、发热、咳嗽、肌肉痉挛、背痛、呕吐、高血压、上呼吸道感染、外周感觉神经病变、便秘、肺炎和外周水肿。

The most common hematology laboratory abnormalities (≥40 percent) with DARZALEX

使用DARZALEX时最常见的血液学实验室异常（≥40％）包括：

FASPRO

法斯普罗

are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.

白细胞减少、淋巴细胞减少、中性粒细胞减少、血小板减少和血红蛋白减少。

Please

请

click here

点击这里

to see the full Prescribing Information for DARZALEX

查看 DARZALEX 的完整处方信息

FASPRO

法斯普罗

。

DARZALEX

达雷木单抗

INDICATIONS AND IMPORTANT SAFETY INFORMATION

适应症和重要安全信息

INDICATIONS

适应症

DARZALEX

达雷木单抗

(daratumumab) is indicated for the treatment of adult patients with MM:

（达拉图单抗）适用于治疗成年多发性骨髓瘤（MM）患者：

In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant

与硼替佐米、美法仑和泼尼松联合用于新诊断的不符合自体干细胞移植条件的患者

与来那度胺和地塞米松联合用于新诊断的不符合自体干细胞移植条件的患者，以及至少接受过一种先前治疗的复发或难治性多发性骨髓瘤（MM）患者。

In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant

与硼替佐米、沙利度胺和地塞米松联合用于新诊断的适合自体干细胞移植的患者

In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor

与泊马度胺和地塞米松联合用于既往至少接受过一种治疗（包括来那度胺和蛋白酶体抑制剂）的患者。

In combination with carfilzomib and dexamethasone in patients with relapsed or refractory MM who have received one to three prior lines of therapy

与卡非佐米和地塞米松联合用于接受过一至三线治疗的复发或难治性MM患者

In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy

与硼替佐米和地塞米松联合用于至少接受过一种先前治疗的患者

As monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent

作为一种单药疗法，用于已接受至少三种先前治疗（包括蛋白酶体抑制剂（PI）和免疫调节剂）或对蛋白酶体抑制剂（PI）和免疫调节剂双重耐药的患者。

CONTRAINDICATIONS

禁忌症

DARZALEX

达雷木单抗

is contraindicated in patients with a history of severe hypersensitivity (eg, anaphylactic reactions) to daratumumab or any of the components of the formulation.

禁用于对达雷妥尤单抗或制剂中任何成分有严重超敏反应史（如过敏性反应）的患者。

WARNINGS AND PRECAUTIONS

警告和注意事项

Infusion-Related Reactions

输液相关反应

DARZALEX

达雷木单抗

can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life-threatening, and fatal outcomes have been reported. In clinical trials (monotherapy and combination: N=2066), infusion-related reactions occurred in 37 percent of patients with the Week 1 (16 mg/kg) infusion, 2 percent with the Week 2 infusion, and cumulatively 6 percent with subsequent infusions.

可能引起严重和/或严重的输液相关反应，包括过敏反应。这些反应可能危及生命，并已有致死性结果的报告。在临床试验中（单药治疗和联合治疗：N=2066），第一周（16 mg/kg）输液时37%的患者出现输液相关反应，第二周输液时为2%，后续输液累计为6%。

Less than 1 percent of patients had a Grade 3/4 infusion-related reaction at Week 2 or subsequent infusions. The median time to onset was 1.5 hours (range: 0 to 73 hours). Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX.

不到1%的患者在第2周或随后的输注中出现了3/4级输注相关反应。中位发病时间为1.5小时（范围：0至73小时）。几乎所有反应都发生在输注期间或完成DARZALEX后4小时内。

. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea.

. 已发生严重反应，包括支气管痉挛、低氧血症、呼吸困难、高血压、心动过速、头痛、喉头水肿、肺水肿以及眼部不良反应，包括脉络膜渗出、急性近视和急性闭角型青光眼。体征和症状可能包括呼吸道症状，如鼻塞、咳嗽、喉咙刺激，以及寒战、呕吐和恶心。

Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension and blurred vision. .

较少见的体征和症状包括喘息、过敏性鼻炎、发热、胸部不适、瘙痒、低血压和视力模糊。

When DARZALEX

当DARZALEX

dosing was interrupted in the setting of ASCT (CASSIOPEIA) for a median of 3.75 months (range: 2.4 to 6.9 months), upon re-initiation of DARZALEX

在ASCT（CASSIOPEIA）背景下，给药中断的中位时间为3.75个月（范围：2.4至6.9个月），重新开始使用DARZALEX时。

, the incidence of infusion-related reactions was 11 percent for the first infusion following ASCT. Infusion-related reactions occurring at re-initiation of DARZALEX

，ASCT后首次输注的输注相关反应发生率为11％。在重新开始使用DARZALEX时发生的输注相关反应

following ASCT were consistent in terms of symptoms and severity (Grade 3 or 4: <1 percent) with those reported in previous studies at Week 2 or subsequent infusions. In EQUULEUS, patients receiving combination treatment (n=97) were administered the first 16 mg/kg dose at Week 1 split over two days, ie, 8 mg/kg on Day 1 and Day 2, respectively.

以下是在 ASCT 后症状和严重程度（3 或 4 级：<1%）与之前在第 2 周或后续输注研究中报告的一致。在 EQUULEUS 试验中，接受联合治疗的患者（n=97）在第 1 周分别接受首次 16 mg/kg 的剂量，分两天注射，即第 1 天和第 2 天分别为 8 mg/kg。

The incidence of any grade infusion-related reactions was 42 percent, with 36 percent of patients experiencing infusion-related reactions on Day 1 of Week 1, 4 percent on Day 2 of Week 1, and 8 percent with subsequent infusions. .

任何级别输注相关反应的发生率为42%，其中36%的患者在第1周的第1天出现输注相关反应，4%在第1周的第2天，8%在随后的输注中出现反应。

Pre-medicate patients with antihistamines, antipyretics, and corticosteroids.

预先用抗组胺药、退烧药和皮质类固醇治疗患者。

Frequently monitor patients during the entire infusion. Interrupt DARZALEX

在输注期间频繁监测患者。中断DARZALEX

infusion for reactions of any severity and institute medical management as needed. Permanently discontinue DARZALEX

输注任何严重程度的反应并根据需要进行医疗管理。永久停止使用DARZALEX。

therapy if an anaphylactic reaction or life-threatening (Grade 4) reaction occurs and institute appropriate emergency care. For patients with Grade 1, 2, or 3 reactions, reduce the infusion rate when re-starting the infusion.

如果发生过敏反应或危及生命（4级）的反应，应进行治疗并实施适当的急救措施。对于1级、2级或3级反应的患者，在重新开始输注时应降低输注速度。

To reduce the risk of delayed infusion-related reactions, administer oral corticosteroids to all patients following DARZALEX

为了减少延迟输注相关反应的风险，所有患者在使用DARZALEX后应给予口服皮质类固醇。

infusions. Patients with a history of chronic obstructive pulmonary disease may require additional post-infusion medications to manage respiratory complications. Consider prescribing short- and long-acting bronchodilators and inhaled corticosteroids for patients with chronic obstructive pulmonary disease. .

输液。有慢性阻塞性肺疾病史的患者可能需要额外的输液后药物来管理呼吸系统并发症。考虑为慢性阻塞性肺疾病患者开具短效和长效支气管扩张剂以及吸入性皮质类固醇。

DARZALEX可能导致眼部不良反应，包括因睫状体脉络膜渗出引起的急性近视和前房角变窄，并有可能增加眼内压或引发青光眼。

infusion. If ocular symptoms occur, interrupt DARZALEX

输注。如果出现眼部症状，中断DARZALEX。

infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX

输注并立即寻求眼科评估，然后重新开始使用DARZALEX

。

Interference With Serological Testing

血清学检测的干扰

Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum.

达雷妥尤单抗与红细胞（RBC）上的CD38结合，并导致间接抗球蛋白试验（间接Coombs试验）呈阳性。达雷妥尤单抗介导的间接抗球蛋白试验阳性可能在最后一次达雷妥尤单抗输注后持续长达6个月。结合到达雷妥尤单抗的红细胞会掩盖患者血清中对次要抗原的抗体检测。

The determination of a patient's ABO and Rh blood type is not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX.

患者ABO和Rh血型的测定不受影响。通知输血中心此干扰涉及血清学检测，并告知血库患者已接受DARZALEX。

. Type and screen patients prior to starting DARZALEX

在开始使用DARZALEX之前，对患者进行分型和筛查。

。

Neutropenia and Thrombocytopenia

中性粒细胞减少症和血小板减少症

DARZALEX

达雷木单抗

may increase neutropenia and thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX.

可能会增加背景治疗引起的中性粒细胞减少和血小板减少。根据背景治疗制造商的处方信息，在治疗期间定期监测全血细胞计数。监测中性粒细胞减少患者的感染迹象。考虑暂停使用DARZALEX。

until recovery of neutrophils or for recovery of platelets.

直到中性粒细胞或血小板恢复。

Interference With Determination of Complete Response

对完全缓解判定的干扰

达雷妥尤单抗是一种人免疫球蛋白G（IgG）κ单克隆抗体，在用于监测内源性M蛋白的血清蛋白电泳（SPE）和免疫固定电泳（IFE）检测中均可被检出。这种干扰可能会影响部分IgG κ型骨髓瘤蛋白患者完全缓解和疾病进展的判定。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

Based on the mechanism of action, DARZALEX

基于作用机制，DARZALEX

can cause fetal harm when administered to a pregnant woman. DARZALEX

在给孕妇使用时，可能会对胎儿造成伤害。DARZALEX

可能导致胎儿免疫细胞耗竭和骨密度降低。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DARZALEX治疗期间采取有效的避孕措施。

and for 3 months after the last dose.

在最后一剂后的3个月内。

The combination of DARZALEX

DARZALEX的组合

with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, pomalidomide, or thalidomide prescribing information on use during pregnancy.

与来那度胺、泊马度胺或沙利度胺联合使用在孕妇中是禁忌的，因为来那度胺、泊马度胺和沙利度胺可能导致胎儿畸形和未出生婴儿的死亡。有关妊娠期间使用的更多信息，请参见来那度胺、泊马度胺或沙利度胺的处方信息。

ADVERSE REACTIONS

不良反应

The most frequently reported adverse reactions (incidence ≥20 percent) were: upper respiratory infection, neutropenia, infusion related reactions, thrombocytopenia, diarrhea, constipation, anemia, peripheral sensory neuropathy, fatigue, peripheral edema, nausea, cough, pyrexia, dyspnea, and asthenia.

最常见的不良反应（发生率≥20％）是：上呼吸道感染、中性粒细胞减少、输液相关反应、血小板减少、腹泻、便秘、贫血、外周感觉神经病变、疲劳、外周水肿、恶心、咳嗽、发热、呼吸困难和乏力。

The most common hematologic laboratory abnormalities (≥40 percent) with DARZALEX.

DARZALEX最常见的血液学实验室异常（≥40%）。

are: neutropenia, lymphopenia, thrombocytopenia, leukopenia, and anemia.

是：中性粒细胞减少症、淋巴细胞减少症、血小板减少症、白细胞减少症和贫血。

Please

请

click here

点击这里

to see the full Prescribing Information.

查看完整的处方信息。

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长，我们有能力在当今整个医疗保健解决方案领域进行创新，以实现明天的突破，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

www.innovativemedicine.jnj.com

. Follow us at

关注我们

@JNJInnovMed

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

杨森研究与发展有限责任公司、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 DARZALEX

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DARZALEX潜在益处和治疗影响的“前瞻性声明”。

FASPRO

法斯普罗

. 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 Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen-Cilag, S.A., Janssen Scientific Affairs, LLC and/or Johnson & Johnson.

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成为现实，实际结果可能与杨森-西拉格国际公司、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、杨森-西拉格股份有限公司、杨森科学事务有限责任公司和/或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更多列表和描述，请参见 Johnson & Johnson 最近的 Form 10-K 年度报告，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 Johnson & Johnson 随后的 Form 10-Q 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网上查阅。

http://www.sec.gov

，

http://www.jnj.com

, or on request from Johnson & Johnson. None of Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen-Cilag, S.A., Janssen Scientific Affairs, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments..

，或者应Johnson & Johnson的要求。Janssen-Cilag International NV、Janssen Research & Development, LLC、Janssen Biotech, Inc.、Janssen Global Services, LLC、Janssen-Cilag, S.A.、Janssen Scientific Affairs, LLC以及Johnson & Johnson均不承担因新信息、未来事件或发展而更新任何前瞻性声明的责任。

‡

Peter Voorhees, M.D., Levine Cancer Institute, Charlotte, N.C.,

彼得·沃赫斯，医学博士，莱文癌症研究所，北卡罗来纳州夏洛特，

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

向强生公司提供过咨询、顾问和演讲服务；他没有因任何媒体工作获得报酬。

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:

美国医学询问：

+1 800 526-7736

Dimopoulos, M.-A. Phase 3 randomized study of daratumumab monotherapy versus active monitoring in patients with high-risk smoldering multiple myeloma: primary results of the AQUILA study. Abstract #773 [Oral Presentation]. Presented at the 2024 American Society of Hematology Annual Meeting.

迪莫普洛斯，M.-A。达拉图单抗单药治疗与积极监测在高风险冒烟型多发性骨髓瘤患者中的3期随机研究：AQUILA研究的主要结果。摘要#773 [口头报告]。在2024年美国血液学会年会上发表。

Dimopoulos, M.-A., et al. Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma. New England Journal of Medicine.

Dimopoulos, M.-A., 等。达拉图单抗或积极监测对于高风险冒烟型多发性骨髓瘤的治疗。新英格兰医学杂志。

https://www.nejm.org/doi/full/10.1056/NEJMoa2409029

. Accessed March 25, 2025.

。引用日期：2025年3月25日。

Rajkumar SV. Multiple Myeloma: 2020 Update on Diagnosis, Risk-Stratification and Management

Rajkumar 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. Accessed August 2024. Available at:

国家癌症研究所。浆细胞肿瘤。2024年8月访问。可于以下网址获取：

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

Multiple Myeloma. City of Hope, 2022. Multiple Myeloma: Causes, Symptoms & Treatments. Accessed August 2024. Available at:

多发性骨髓瘤。希望之城，2022。多发性骨髓瘤：原因、症状与治疗。2024年8月访问。可用链接：

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

American Cancer Society. Myeloma Cancer Statistics. Accessed August 2024. Available at:

美国癌症协会。骨髓瘤癌症统计。2024年8月访问。可用地址：

https://cancerstatisticscenter.cancer.org/types/myeloma

https://cancerstatisticscenter.cancer.org/types/骨髓瘤

American Cancer Society. What is Multiple Myeloma? Accessed August 2024. Available at:

美国癌症协会。什么是多发性骨髓瘤？2024年8月访问。可用链接：

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

American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging. Accessed August 2024. Available at:

美国癌症协会。多发性骨髓瘤的早期检测、诊断和分期。2024年8月访问。可用链接：

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

View original content to download multimedia:

查看原始内容以下载多媒体：

https://www.prnewswire.com/news-releases/us-fda-oncologic-drugs-advisory-committee-votes-in-favor-of-the-benefit-risk-profile-of-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-for-high-risk-smoldering-multiple-myeloma-302461151.html

https://www.prnewswire.com/news-releases/美国食品药品监督管理局肿瘤药物咨询委员会投票支持达尔扎莱克斯-法斯普罗-达拉图单抗和透明质酸酶-fihj治疗高风险隐匿性多发性骨髓瘤的效益风险特征-302461151.html

SOURCE Johnson & Johnson

来源：强生公司

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