基于DARZALEX FASPRO®（达雷妥尤单抗和透明质酸酶-fihj）的治疗方案显示，在适合移植的新诊断多发性骨髓瘤患者中，达到持续MRD阴性的患者四年无进展生存率为95%-动脉网

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant-eligible, newly diagnosed patients with multiple myeloma who achieved sustained MRD negativity

强生等信源发布 2025-06-03 04:08



可切换为仅中文







More than half of patients maintained minimal residual disease (MRD) negativity (10

超过一半的患者保持了微小残留病（MRD）阴性（10

-5

) with DARZALEX FASPRO

) 与 DARZALEX FASPRO

for 24 months or longer in the Phase 3 PERSEUS study

在第 3 阶段 PERSEUS 研究中持续 24 个月或更长时间

Data from Phase 3 CEPHEUS study show 60 percent overall MRD negativity (10

第3阶段CEPHEUS研究的数据表明，总体MRD阴性率为60％（10

−5

) and improved PFS with DARZALEX FASPRO

）并使用DARZALEX FASPRO改善了PFS

in transplant-ineligible newly diagnosed patients

在不符合移植条件的新诊断患者中

CHICAGO

芝加哥

，

June 3, 2025

2025年6月3日

/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced data from two studies highlighting that a DARZALEX

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布了两项研究的数据，重点表明 DARZALEX

FASPRO

法斯普罗

(daratumumab and hyaluronidase-fihj)-based quadruplet regimen demonstrated deep and sustained minimal residual disease (MRD) negativity rates, and improved long-term progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status.

基于达拉图单抗和透明质酸酶-fihj的四联方案在新诊断的多发性骨髓瘤（NDMM）患者中展现出深度且持续的微小残留病（MRD）阴性率，并改善了长期无进展生存期（PFS），无论移植状态如何。

1,2,3

Findings were highlighted as oral presentations of an analysis of sustained MRD in transplant-eligible patients from the Phase 3 PERSEUS study (Abstract #7501) and a subgroup analysis of transplant-ineligible patients in the Phase 3 CEPHEUS study (Abstract #7516) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting..

2025年美国临床肿瘤学会（ASCO）年会上，口头报告了来自3期PERSEUS研究（摘要#7501）中关于适合移植患者的持续MRD分析结果，以及3期CEPHEUS研究（摘要#7516）中不适合移植患者的亚组分析结果。

New analysis from the Phase 3 PERSEUS study shows the addition of DARZALEX

第3阶段PERSEUS研究的新分析显示，添加DARZALEX

FASPRO

法斯普罗

to bortezomib, lenalidomide and dexamethasone (D-VRd), followed by an investigational maintenance regimen of DARZALEX

硼替佐米、来那度胺和地塞米松 (D-VRd) 治疗，随后使用 DARZALEX 进行试验性维持治疗方案

FASPRO

法斯普罗

with lenalidomide (D-R), led to improved and deepened rates of overall and sustained MRD negativity (10

与来那度胺（D-R）联用，提高了总体和持续的微小残留病阴性率（10

-5

), defined as no cancer cells detected within 100,000 bone marrow cells) for at least 24 months, compared to VRd induction and consolidation with R maintenance. More than half of patients who received the DARZALEX

)，定义为在100,000个骨髓细胞中未检测到癌细胞，持续至少24个月，相对于VRd诱导和巩固以及R维持治疗。超过一半接受DARZALEX的患者

FASPRO

-based regimen achieved sustained MRD negativity for 24 or more months and more than two-thirds of patients achieved sustained MRD-negativity at 12-months, showing 95.3 percent PFS at 48-months (95 percent confidence interval [CI], 0.3-2.3)—reinforcing the ability of DARZALEX

基于该方案实现了持续24个月或更长时间的MRD阴性，超过三分之二的患者在12个月时达到了持续的MRD阴性，显示48个月时PFS达到95.3%（95%置信区间[CI]，0.3-2.3），进一步证明了DARZALEX的能力。

FASPRO

to delay disease progression or death.

延迟疾病进展或死亡。

'The data show that D-VRd followed by an investigational D-R maintenance regimen is a highly effective treatment option for transplant-eligible patients with newly diagnosed multiple myeloma,' said Philippe Moreau*, M.D., head of the Hematology Department, University Hospital Hôtel-Dieu, Nantes, France and presenting author.

“数据显示，D-VRd联合后续的试验性D-R维持方案，是适合移植的新诊断多发性骨髓瘤患者的高效治疗选择，”法国南特大学医院Hôtel-Dieu血液科主任、报告作者Philippe Moreau医学博士表示。

'The depth and durability of MRD negativity observed—paired with unprecedented progression-free survival at four years—underscore the long-term benefit the DARZALEX .

“观察到的MRD阴性深度和持久性——加上四年后前所未有的无进展生存期——突显了DARZALEX的长期益处。”

FASPRO

法斯普罗

-based regimen can offer patients early in their treatment journey.'

基于…的方案可以在治疗过程的早期提供给患者。

At a median follow-up of 47.5 months, 24-month sustained MRD negativity rates at the 10⁻⁵ sensitivity threshold were more than double with D-VRd followed by investigational D-R maintenance (55.8 percent), compared to VRd followed by R maintenance (22.6 percent) (odds ratio [OR]=4.36; 95 percent CI, 3.15-6.05; P<0.0001).

在中位随访47.5个月时，在10⁻⁵敏感性阈值下，D-VRd后接研究性D-R维持治疗的24个月持续MRD阴性率（55.8%）是VRd后接R维持治疗（22.6%）的两倍以上（比值比[OR]=4.36；95%置信区间，3.15-6.05；P<0.0001）。

Similarly, MRD negativity at 12 months was higher with D-VRd and D-R maintenance at 64.8 percent compared to VRd and R maintenance (29.7 percent) (OR=4.42, 95 percent CI, 3.22-6.08, P<0.0001)..

同样，使用D-VRd和D-R维持治疗12个月时，MRD阴性率较高，达到64.8％，而使用VRd和R维持治疗的阴性率为29.7％（OR=4.42，95％CI，3.22-6.08，P<0.0001）。

Additional data from Phase 3 CEPHEUS study explore the benefits of DARZALEX

CEPHEUS 第三阶段研究的更多数据探索了DARZALEX 的益处

FASPRO

法斯普罗

in transplant-ineligible patients across cytogenetic risk status

在不符合移植条件的患者中，跨越细胞遗传学风险状态

The post-hoc analysis of the Phase 3 CEPHEUS study focused exclusively on transplant-ineligible patients, reinforcing that adding DARZALEX

第3阶段CEPHEUS研究的事后分析完全集中在不符合移植条件的患者身上，进一步证实了添加DARZALEX的效果。

FASPRO

法斯普罗

to VRd significantly deepens response and prolongs PFS compared to VRd alone, even in patients who are older and considered frail by the Myeloma Geriatric Assessment score.

与单独使用VRd相比，添加治疗显著加深了反应并延长了PFS，即使在年龄较大且根据骨髓瘤老年评估评分被认为体弱的患者中也是如此。

At a median follow-up of 58.7 months, patients receiving D-VRd achieved markedly higher overall MRD negativity rates at the 10⁻⁵ sensitivity threshold with 60.4 percent versus 39.3 percent with VRd (OR 2.37; 95 percent CI, 1.47–3.80; P=0.0004). Furthermore, treatment with D-VRd resulted in high MRD-negativity rates at the 10⁻⁶ threshold (no cancer cells detected within 1,000,000 bone marrow cells) with 45.8 percent compared to 26.9 percent with VRd (OR 2.28; 95 percent CI, 1.40–3.73; P=0.0010).

在中位随访58.7个月时，接受D-VRd治疗的患者在10⁻⁵敏感性阈值下整体MRD阴性率显著更高，达到60.4%，而VRd组为39.3%（OR 2.37；95% CI，1.47–3.80；P=0.0004）。此外，D-VRd治疗在10⁻⁶阈值（在1,000,000个骨髓细胞中未检测到癌细胞）下也实现了较高的MRD阴性率，为45.8%，而VRd组为26.9%（OR 2.28；95% CI，1.40–3.73；P=0.0010）。

These deeper responses translated into improved long-term outcomes, with 69 percent of patients remaining progression free at 54-months when treated with D-VRd versus 48.0 percent with VRd (hazard ratio [HR] 0.51; 95 percent CI, 0.35–0.74). Overall survival (OS) numerically favored D-VRd (HR 0.66; 95 percent CI, 0.42–1.03), with an even greater benefit observed after censoring for COVID-19-related deaths (HR 0.55; 95 percent CI, 0.34–0.90)..

这些更深层次的缓解转化为长期预后的改善，使用 D-VRd 治疗的患者在 54 个月时有 69% 无疾病进展，而使用 VRd 的患者为 48.0%（风险比 [HR] 0.51；95% 置信区间 [CI]，0.35–0.74）。总体生存率 (OS) 数值上更倾向于 D-VRd（HR 0.66；95% CI，0.42–1.03），在剔除与 COVID-19 相关的死亡后，观察到更大的益处（HR 0.55；95% CI，0.34–0.90）。

Additional data presented at ASCO included a subgroup analysis of the CEPHEUS trial for both transplant-ineligible and deferred NDMM patients who were considered high-risk for cytogenetic abnormalities (Abstract #7529). At a median follow-up of 58.7 months, overall MRD negativity rate was improved for patients with standard risk in D-VRd versus VRd.

在ASCO上展示的更多数据包括对CEPHEUS试验的亚组分析，针对移植不合格和延迟治疗的NDMM患者，这些患者被认为具有高风险的细胞遗传学异常（摘要#7529）。在中位随访58.7个月时，与VRd相比，D-VRd在标准风险患者中的总体MRD阴性率有所提高。

Rates by treatment arm in patients at high risk were comparable..

高危患者的治疗组间比率相当。

'Across multiple studies, the growing body of data on DARZALEX-based regimens indicates impressive, deep responses and meaningful progression-free survival in patients with newly diagnosed multiple myeloma, including high risk,' Jordan Schecter, MD, Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.

“在多项研究中，基于DARZALEX方案的越来越多的数据表明，在新诊断的多发性骨髓瘤患者（包括高危患者）中产生了令人印象深刻的深度缓解和有意义的无进展生存期。” 约旦·谢克特医学博士，强生创新医学副总裁，多发性骨髓瘤领域负责人。

'These consistent results across patient populations, regardless of transplant eligibility, reinforce the role of DARZALEX .

“这些在不同患者群体中一致的结果，不论移植资格如何，都强化了DARZALEX的作用。”

FASPRO

法斯普罗

as a cornerstone of frontline therapy.'

作为一线治疗的基石。

In the PERSEUS and CEPHEUS studies, the safety profiles were consistent with the known safety profile for DARZALEX

在PERSEUS和CEPHUS研究中，安全性特征与DARZALEX的已知安全性特征一致。

FASPRO

。

About the PERSEUS Study

关于PERSEUS研究

The PERSEUS study is being conducted in collaboration with the European Myeloma Network as the sponsor. PERSEUS is an ongoing, randomized, open-label, Phase 3 study comparing the efficacy and safety of D-VRd during induction and consolidation versus VRd during induction and consolidation in patients with NDMM eligible for ASCT.

PERSEUS 研究正与欧洲骨髓瘤网络合作进行，其作为赞助方。PERSEUS 是一项正在进行的随机、开放标签的 3 期研究，比较在适合自体干细胞移植（ASCT）的新诊断多发性骨髓瘤（NDMM）患者中，D-VRd 方案与 VRd 方案在诱导和巩固治疗阶段的疗效和安全性。

Following consolidation, patients received an investigational treatment regimen for maintenance that included DARZALEX .

巩固治疗后，患者接受了一种包含 DARZALEX 的研究性维持治疗方案。

FASPRO

法斯普罗

in combination with lenalidomide or lenalidomide alone. The trial was not designed to isolate the effect of DARZALEX

与来那度胺联合使用或单独使用来那度胺。该试验并未设计为孤立地评估DARZALEX的效果。

FASPRO

法斯普罗

in the maintenance phase of treatment. The efficacy of DARZALEX

在治疗的维持阶段。DARZALEX的有效性

FASPRO

法斯普罗

in combination with lenalidomide for maintenance has not been established. The primary endpoint is PFS, and secondary endpoints include overall CR or better rate, and overall MRD-negativity (in patients with CR or better). The median age is 61.0 (range, 32-70) years for patients in the D-VRd arm and 59.0 (range, 31-70) years for patients in the VRd arm..

与来那度胺联合用于维持治疗的疗效尚未确定。主要终点是无进展生存期（PFS），次要终点包括总体完全缓解（CR）或更佳率，以及总体微小残留病阴性率（MRD-negativity，在达到CR或更佳的患者中）。D-VRd组患者的中位年龄为61.0岁（范围32-70岁），VRd组患者的中位年龄为59.0岁（范围31-70岁）。

The study is being conducted in 14 countries in Europe and Australia.

该研究正在欧洲和澳大利亚的14个国家进行。

About the CEPHEUS Study

关于CEPHEUS研究

CEPHEUS (

NCT03652064

) is an ongoing, multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of D-VRd versus VRd in patients with newly diagnosed multiple myeloma who are transplant-ineligible or for whom transplant is not intended as initial therapy. Primary endpoint is overall MRD negativity rate at 10.

）是一项正在进行的、多中心、随机、开放标签的 3 期研究，比较 D-VRd 与 VRd 在新诊断的、不符合移植条件或未计划将移植作为初始治疗的多发性骨髓瘤患者中的疗效和安全性。主要终点是第 10 个月时的整体 MRD 阴性率。

-5

sensitivity threshold. Secondary endpoints include CR or better rates, PFS, sustained MRD negativity rates for ≥12 months, MRD-negative rate at one year, overall response rates, time to and duration of response, PFS on next line of therapy, overall survival and safety. The trial has enrolled 396 patients in 13 countries..

敏感性阈值。次要终点包括CR或更佳率、PFS、持续MRD阴性率（≥12个月）、一年时的MRD阴性率、总缓解率、缓解的时间和持续时间、下一线治疗的PFS、总生存期和安全性。该试验已在13个国家招募了396名患者。

About Multiple Myeloma

关于多发性骨髓瘤

Multiple myeloma (MM) 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（MM）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、钙水平高、肾脏问题或感染。

8,9

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

这是唯一获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，并已在八种适应症中获批，其中三种适应症用于前线治疗，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应用于超过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达成了一项全球协议，该协议授予杨森独家许可，以开发、生产和商业化daratumumab。

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

INDICATIONS AND IMPORTANT SAFETY INFORMATION

适应症和重要的安全信息

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) 适用于治疗成年多发性骨髓瘤（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且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接受过至少一种先前治疗（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至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难治的患者。

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）和局部注射部位反应。

FASPRO

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

. 已有含达雷妥尤单抗的产品（包括DARZALEX）报告了致命反应

FASPRO

法斯普罗

。

Systemic Reactions

系统性反应

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

在1249名接受DARZALEX FASPRO®单药治疗或联合治疗的多发性骨髓瘤（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，7%的患者出现了全身性给药相关反应（2级：3.2%，3级：0.7%，4级：0.1%）。

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. 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 .

系统性给药相关反应在首次注射时发生于7%的患者，第二次注射时为0.2%，随后的注射中累计发生率为1%。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次系统性给药相关反应中，144次（87%）发生在DARZALEX注射当天。

FASPRO

法斯普罗

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

管理。1%的患者发生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。与全身给药相关的反应的其他体征和症状可能包括呼吸系统症状，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给患者用药。监测患者是否出现与全身给药相关的反应，尤其是在第一和第二次注射后。对于过敏反应或危及生命（4级）的给药相关反应，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

在给予DARZALEX后，考虑使用皮质类固醇和其他药物。

FASPRO

法斯普罗

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

取决于剂量方案和病史，以尽量减少延迟（定义为发生在给药后第二天）的系统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发生眼部不良反应，包括因睫状体脉络膜渗出导致的急性近视和前房角变窄，并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

并在重新开始使用DARZALEX之前立即寻求眼科评估

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后中位数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

达拉图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。考虑暂停使用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。在接受DARZALEX的较低体重患者中

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。根据背景疗法的制造商处方信息，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。建议有生殖潜力的女性在使用DARZALEX治疗期间采取有效的避孕措施。

FASPRO

法斯普罗

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时，孕妇禁用，因为来那度胺、沙利度胺和泊马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、沙利度胺或泊马度胺的处方信息。

Interference With Serological Testing

对血清学检测的干扰

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使用达雷妥尤单抗后持续长达6个月。结合到红细胞上的达雷妥尤单抗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

通知血清学检测受到干扰的输血中心，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

法斯普罗

。

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）检测中均可被检测到。这种干扰可能会影响某些DARZALEX治疗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

法斯普罗

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

达雷木单抗最常见的血液学实验室异常（≥40%）包括

FASPRO

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

。

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方案（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使用，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 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，用于接受过至少三线既往治疗（包括一种蛋白酶体抑制剂 (PI) 和一种免疫调节剂）的患者，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.

对达雷妥尤单抗或制剂中任何成分有严重过敏史（如过敏性反应）的患者禁用。

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.

可能导致严重和/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），37%的患者在第1周（16 mg/kg）输液时发生输液相关反应，2%的患者在第2周输液时发生反应，后续输液的累计发生率为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周或后续输注时出现3/4级输注相关反应。中位起始时间为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，包括脉络膜积液、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

当达雷木单抗（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）环境下，给药中断的中位时间为3.75个月（范围：2.4至6.9个月），随后重新开始DARZALEX。

, 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.

在ASCT后的症状和严重程度（3级或4级：<1％）与之前研究中报道的在第2周或后续输注时的情况一致。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，分为两天进行，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%的患者在第1周的第2天出现反应，8%的患者在后续输注中出现反应。

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

为了减少延迟性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。对于慢性阻塞性肺疾病患者，考虑开具短效和长效支气管扩张剂以及吸入性皮质类固醇。

DARZALEX 引发的眼部不良反应包括因睫状体脉络膜渗出导致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

输注并寻求立即的眼科评估，然后重新开始使用DARZALEX

。

Interference With Serological Testing

干扰血清学检测

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（RBCs）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为止。

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，在用于内源性M蛋白临床监测的血清蛋白电泳（SPE）和免疫固定（IFE）检测中均可被检测到。这种干扰可能会影响部分IgGκ骨髓瘤蛋白患者的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

当给孕妇使用时，可能对胎儿造成伤害。DARZALEX

可能导致胎儿免疫细胞耗竭和骨密度下降。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合用时，孕妇禁用，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％）包括：上呼吸道感染、中性粒细胞减少、输注相关反应、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优势使我们能够构建一个世界，在这个世界里，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

或者在

www.innovativemedicine.jnj.com

. Follow us at

关注我们

@JNJInnovMed

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

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

Cautions Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

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

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

。

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

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

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

风险和不确定性包括但不限于：产品研究和开发中固有的挑战和不确定性，包括临床成功的不确定性和获得监管批准的不确定性；商业成功的不确定性；生产困难和延误；竞争，包括技术进步、竞争对手推出的新产品和获得的专利；专利面临的挑战；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；适用法律法规的变动，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年度报告 Form 10-K，包括标题为“关于前瞻性陈述的警示声明”和“Item 1A. 风险因素”的部分，以及强生公司随后的季度报告 Form 10-Q 和其他提交给证券交易委员会的文件。

Copies of these filings are available online .

这些文件的副本可在线获取。

在

http://www.sec.gov

，

http://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、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

Philippe Moreau, M.D., head of the Hematology Department, University Hospital Hôtel-Dieu, Nantes, France

法国南特大学医院Hôtel-Dieu血液科主任Philippe Moreau医学博士

, has provided consulting, advisory, and speaking services to Johnson & Johnson; he 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；他未因任何媒体工作获得报酬。

_______________________________

_________________________________

Moreau, P., et al. Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone (VRd) with Dara + lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trial.

Moreau, P., 等。皮下注射达雷妥尤单抗 (Dara) + 硼替佐米/来那度胺/地塞米松 (VRd)，随后使用达雷妥尤单抗 + 来那度胺 (DR) 维持治疗，用于适合移植 (TE) 的新诊断多发性骨髓瘤 (NDMM) 患者：3 期 PERSEUS 试验中持续微小残留病阴性的分析。

2025 American Society of Clinical Oncology Annual Meeting. June 2025..

2025年美国临床肿瘤学会年会。2025年6月。

Facon, T., et al. Daratumumab plus bortezomib, lenalidomide and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): subgroup analysis of transplant-ineligible (TIE) patients in the Phase 3 CEPHEUS study. 2025 American Society of Clinical Oncology Annual Meeting. June 2025..

Facon, T. 等。达雷妥尤单抗联合硼替佐米、来那度胺和地塞米松（DVRd）治疗新诊断的多发性骨髓瘤（NDMM）：CEPHEUS 3期研究中不符合移植条件（TIE）患者的亚组分析。2025年美国临床肿瘤学会年会，2025年6月。

Bahlis, N., et al. Daratumumab + bortezomib, lenalidomide, and dexamethasone (DVRd) vs VRd in transplant-ineligible (TIE)/transplant-deferred (TD) newly diagnosed multiple myeloma (NDMM): Phase 3 CEPHEUS trial cytogenetic subgroup analysis. 2025 American Society of Clinical Oncology Annual Meeting.

巴赫利斯，N.，等。达拉图单抗+硼替佐米、来那度胺和地塞米松（DVRd）对比VRd在不符合移植条件（TIE）/延迟移植（TD）新诊断多发性骨髓瘤（NDMM）中的应用：3期CEPHEUS试验细胞遗传学亚组分析。2025年美国临床肿瘤学会年会。

June 2025..

2025年6月。。

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。网址：

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：病因、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。可用链接：

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。可用地址：

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

Media contact:

媒体联系人：

Investor contact:

投资者联系人：

Oncology Media Relations

肿瘤学媒体关系

Lauren Johnson

劳伦·约翰逊

Oncology_media_relations@its.jnj.com

肿瘤学媒体关系@its.jnj.com

investor-relations@its.jnj.com

投资者关系@its.jnj.com

U.S. medical inquiries:

美国医学咨询：

+1 800 526-7736

View original content to download multimedia:

查看原始内容以下载多媒体：

https://www.prnewswire.com/news-releases/darzalex-faspro-daratumumab-and-hyaluronidase-fihj-based-regimen-shows-95-percent-progression-free-survival-at-four-years-in-transplant-eligible-newly-diagnosed-patients-with-multiple-myeloma-who-achieved-sustained-mrd-negativ-302472089.html

https://www.prnewswire.com/news-releases/darzalex-faspro-（达雷妥尤单抗和透明质酸酶fihj）方案显示，四年内在适合移植的新诊断多发性骨髓瘤患者中，达到持续微小残留病阴性的患者有95%的无进展生存率-302472089.html

SOURCE Johnson & Johnson

来源：强生公司

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