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百时美施贵宝在ASH 2023对低风险骨髓增生异常综合征患者进行重组治疗红细胞生成刺激剂钠血症的3期COMMAND试验的主要疗效和安全性分析

Bristol Myers Squibb Presents Primary Efficacy and Safety Analysis of the Phase 3 COMMANDS Trial of Reblozyl for Treatment of Anemia in Erythropoiesis Stimulating Agent-Naïve Patients with Lower-Risk Myelodysplastic Syndromes at ASH 2023

businesswire 等信源发布 2023-12-10 05:00

可切换为仅中文


PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) announced updated results from the primary analysis of the Phase 3 COMMANDS trial, comparing Reblozyl® (luspatercept-aamt) versus epoetin alfa for the treatment of anemia in erythropoiesis stimulating agent (ESA)-naïve patients with lower-risk myelodysplastic syndromes (MDS) (Oral Presentation #193) who may require red blood cell (RBC) transfusions.

普林斯顿,新泽西州--(商业新闻短讯)--百时美施贵宝(纽约证券交易所:BMY)宣布了对第三阶段COMMANDS试验的初步分析的最新结果,比较Reblozyl®(luspatercept aamt)与epoetin alfa治疗红细胞生成刺激剂(ESA)贫血的疗效-可能需要红细胞(RBC)输注的低风险骨髓增生异常综合征(MDS)初治患者(口服#193)。

These data are being presented in an oral presentation at the 2023 American Society of Hematology (ASH) Annual Meeting, from December 9-12..

这些数据将在12月9日至12日举行的2023年美国血液学会(ASH)年会上进行口头介绍。。

“These data from the COMMANDS trial, including additional patients and longer follow-up from the data shown at ASCO, confirm the positive outcome of the interim analysis with superior efficacy and durability compared to ESAs and exemplify how Reblozyl may impact the treatment of anemia related to MDS,” said Guillermo Garcia-Manero, M.D., lead investigator and Chief of the Section of Myelodysplastic Syndromes at The University of Texas MD Anderson Cancer Center.

医学博士吉列尔莫·加西亚·马内罗(Guillermo Garcia Manero)说:“来自COMMANDS试验的这些数据,包括额外的患者和ASCO所显示数据的更长时间的随访,证实了中期分析的积极结果,与ESA相比具有更高的疗效和耐久性,并举例说明了雷布唑如何影响与MDS相关的贫血的治疗。”。,德克萨斯大学MD安德森癌症中心首席研究员兼骨髓增生异常综合征科科长。

“Further, beyond the intent-to-treat population, the analysis confirms that Reblozyl demonstrated clinical benefit across subgroups.”.

“此外,除了意向治疗人群外,分析证实,雷布唑在各亚组中均显示出临床益处。”。

Results from COMMANDS are under review with the European Commission and served as the basis of a priority review approval by the United States Food and Drug Administration in August 2023 for Reblozyl as a treatment for anemia in ESA-naïve adult patients with very low- to intermediate-risk MDS who may require regular RBC transfusions.

命令的结果正在与欧盟委员会进行审查,并作为美国食品和药物管理局2023年8月优先审查批准的基础,用于治疗ESA初治的极低至中等风险MDS成年患者的贫血,这些患者可能需要定期输注红细胞。

Reblozyl is being developed and commercialized through a global collaboration with Merck as of November 2021..

截至2021年11月,Reblozyl正在通过与默克的全球合作进行开发和商业化。。

COMMANDS Primary Results

命令主要结果

At the time of the primary analysis (March 31, 2023), 363 patients were randomized 1:1 to Reblozyl and epoetin alfa. Results from the primary analysis of the intent to treat (ITT) population showed:

在初步分析时(2023年3月31日),363名患者以1:1的比例随机分配到雷布唑和依泊汀阿尔法。意向治疗(ITT)人群的初步分析结果显示:

60.4% (n=110) of patients receiving Reblozyl vs. 34.8% (n=63) of patients receiving epoetin alfa achieved the primary endpoint of RBC-TI of at least 12 weeks with concurrent mean hemoglobin (Hb) increase of at least 1.5 g/dL within the first 24 weeks (p<0.0001).

60.4%(n=110)接受雷布唑治疗的患者与34.8%(n=63)接受epoetin alfa治疗的患者达到至少12周的RBC-TI主要终点,同时平均血红蛋白(Hb)在前24周内增加至少1.5 g/dL(p<0.0001)。

Erythroid response (HI-E) increase of at least 8 weeks was achieved by 74.2% (n=135) of Reblozyl patients vs. 53% (n=96) of epoetin alfa patients (p<0.0001).

74.2%(n=135)的Reblozyl患者与53%(n=96)的epoetin alfa患者相比,红细胞反应(HI-E)至少增加了8周(p<0.0001)。

RBC transfusion independence (RBC-TI) of at least 12 weeks was achieved by 68.1% (n=124) of Reblozyl patients vs. 48.6% (n=88) of epoetin alfa patients (p<0.0001).

68.1%(n=124)的Reblozyl患者与48.6%(n=88)的epoetin alfa患者实现了至少12周的RBC输血独立性(RBC-TI)(p<0.0001)。

Duration of response was 126.6 weeks (99-NE) for Reblozyl in patients who achieved TI for at least 12 weeks (achieved weeks 1-24) compared to 89.7 weeks (61.9-123.9) for epoetin alfa (Hazard Ratio [HR]: 0.586; 95% Confidence Interval [CI]: 0.380-0.904, p=0.0147).

对于达到TI至少12周(达到第1-24周)的患者,雷布唑的反应持续时间为126.6周(99-NE),而epoetin alfa的反应持续时间为89.7周(61.9-123.9)(危险比[HR]:0.586;95%置信区间[CI]:0.380-0.904,p=0.0147)。

“As patients with lower-risk MDS often receive limited benefit from current standard therapies, including ESAs, these confirmatory data further show how Reblozyl has the potential to create a paradigm shift in the treatment of anemia associated with this disease,” said Anne Kerber, senior vice president, Head of Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), Bristol Myers Squibb..

高级副总裁、晚期临床开发、血液学、肿瘤学、细胞治疗(HOCT)负责人安妮·科伯(AnneKerber)说:“由于MDS风险较低的患者通常从包括ESA在内的当前标准疗法中获得的益处有限,这些确证性数据进一步表明,雷布唑有可能在治疗与该疾病相关的贫血方面产生范式转变。”,百时美施贵宝。。

Safety results were consistent with previous MDS studies, and progression to acute myeloid leukemia and total deaths were similar between arms of the study. The most common treatment-emergent adverse events in at least 10% of patients were diarrhea, fatigue, COVID-19, hypertension, dyspnea, nausea, peripheral edema, asthenia, dizziness, anemia, back pain and headache.

安全性结果与之前的MDS研究一致,研究组之间急性髓细胞白血病的进展和总死亡率相似。至少10%的患者中最常见的治疗紧急不良事件是腹泻,疲劳,新型冠状病毒肺炎,高血压,呼吸困难,恶心,外周水肿,虚弱,头晕,贫血,背痛和头痛。

Rates of reported fatigue and asthenia were shown to decrease over time..

报告的疲劳和虚弱率随着时间的推移而下降。。

In addition to the overall benefit observed in the ITT population, sub-analyses confirmed similar or greater RBC-TI of Reblozyl compared to epoetin alfa regardless of mutational profile, IPSS-M status, ring sideroblast status, transfusion burden and serum erythropoietin (sEPO) level. Duration of RBC-TI favored Reblozyl across all subgroups, including ring sideroblast status..

除了在ITT人群中观察到的总体益处外,亚分析证实,无论突变特征,IPSS-M状态,环铁粒幼细胞状态,输血负担和血清促红细胞生成素(sEPO)水平如何,与依泊汀α相比,雷布唑的RBC-TI相似或更高。RBC-TI的持续时间有利于所有亚组的Reblozyl,包括环状铁粒幼细胞状态。。

Finally, three posters will be presented highlighting additional analyses of the COMMANDS study and the mechanism of Reblozyl.

最后,将展示三张海报,重点介绍对COMMANDS研究和Reblozyl机制的其他分析。

Reblozyl showed favorability over epoetin alfa in various mutational background observed in lower-risk MDS in an analysis of response by mutational burden (Poster Presentation #4591).

在突变负荷反应分析中,在低风险MDS中观察到的各种突变背景下,Reblozyl比epoetin alfa表现出更好的适应性(海报展示#4591)。

An analysis of clonal-hematopoiesis related mutations (Poster Presentation #3214) showed that 85% of patients in the COMMANDS study had at least one CHIP-related mutation. Further, Reblozyl was associated with the downregulation of inflammatory gene signatures and upregulation of anti-inflammatory pathways..

对克隆性造血相关突变的分析(海报展示#3214)显示,在COMMANDS研究中,85%的患者至少有一个与芯片相关的突变。此外,Reblozyl与炎症基因特征的下调和抗炎途径的上调有关。。

In another analysis (Poster Presentation #1845), Reblozyl was associated with modulation of inflammation and restoration of effective erythropoiesis in bone marrow samples from the COMMANDS study, reinforcing its role in the expansion and maturation of early and late-stage erythroid precursors.

在另一项分析(海报展示#1845)中,Reblozyl与COMMANDS研究中骨髓样本中炎症的调节和有效红细胞生成的恢复有关,增强了其在早期和晚期红细胞前体扩增和成熟中的作用。

About COMMANDS

关于命令

COMMANDS (NCT03682536) is a Phase 3, open-label, randomized study evaluating the efficacy and safety of Reblozyl versus epoetin alfa for the treatment of anemia due to very low-, low- or intermediate-risk (IPSS-R) myelodysplastic syndrome (MDS) in patients who are red blood cell (RBC) transfusion dependent and were erythropoiesis stimulating agent (ESA)-naïve..

COMMANDS(NCT03682536)是一项3期开放标签随机研究,评估雷布唑与epoetin alfa治疗极低,低或中等风险(IPSS-R)骨髓增生异常综合征(MDS)引起的贫血的疗效和安全性。红细胞(RBC)输注依赖性和红细胞生成刺激剂(ESA)天真的患者。。

The primary endpoint evaluated in this study is RBC transfusion independence (RBC-TI) for 12 weeks with a mean hemoglobin (Hb) increase ≥1.5 g/dL. Key secondary endpoints include erythroid response (HI-E) of at least 8 weeks during weeks 1-24 of the study, RBC-TI ≥12 weeks and RBC-TI for 24 weeks. Eligible patients were ≥18 years old with lower-risk MDS who require transfusions.

本研究评估的主要终点是红细胞输血独立性(RBC-TI),持续12周,平均血红蛋白(Hb)增加≥1.5 g/dL。关键的次要终点包括研究第1-24周至少8周的红细胞反应(HI-E),RBC-TI≥12周和RBC-TI持续24周。符合条件的患者年龄≥18岁,需要输血的MDS风险较低。

Patients were randomized 1:1 to receive subcutaneous Reblozyl (starting dose 1.0 mg/kg, titration up to 1.75 mg/kg) once every 3 weeks or epoetin alfa (starting dose 450 IU/kg, titration up to 1050 IU/kg) weekly for ≥24 weeks. The majority of study participants (>90%) were outside of the United States and a non-U.S.-licensed epoetin alfa product was used in the control arm for such patients..

患者以1:1的比例随机接受皮下注射雷布唑(起始剂量1.0 mg/kg,滴定至1.75 mg/kg),每3周一次或依泊汀阿尔法(起始剂量450 IU/kg,滴定至1050 IU/kg)每周≥24周。大多数研究参与者(>90%)不在美国和非美国。S、 -这些患者的对照组使用了许可的epoetin alfa产品。。

About MDS

关于MDS

Myelodysplastic syndromes (MDS) are a group of closely related blood cancers characterized by ineffective production of healthy red blood cells (RBC), white blood cells and platelets, which can lead to anemia and frequent or severe infections. People with MDS who develop anemia often require blood transfusions to increase the number of healthy RBCs in circulation.

骨髓增生异常综合征(MDS)是一组密切相关的血癌,其特征在于健康红细胞(RBC),白细胞和血小板的无效产生,这可能导致贫血和频繁或严重感染。患有贫血的MDS患者通常需要输血以增加循环中健康红细胞的数量。

Frequent transfusions are associated with an increased risk of iron overload, transfusion reactions and infections. Patients who become RBC transfusion-dependent have a significantly shorter overall survival than those who are not dependent on transfusions, partially due to iron overload or to more severe bone marrow disease than in non-transfusion dependent patients..

频繁输血会增加铁超负荷、输血反应和感染的风险。与不依赖输血的患者相比,依赖红细胞输血的患者的总生存期明显缩短,部分原因是铁超负荷或比不依赖输血的患者更严重的骨髓疾病。。

About Reblozyl® (luspatercept-aamt)

关于Reblozyl®(luspatercept aamt)

REBLOZYL® (luspatercept-aamt), a first-in-class therapeutic option, promotes late-stage red blood cell maturation in animal models. REBLOZYL is being developed and commercialized through a global collaboration and North American co-promotion with Merck following Merck’s acquisition of Acceleron Pharma, Inc.

REBLOZYL®(luspatercept aamt)是一流的治疗选择,可促进动物模型中晚期红细胞的成熟。在默克收购Acceleron Pharma,Inc.后,通过与默克的全球合作和北美共同推广,REBLOZYL正在开发和商业化。

in November 2021. REBLOZYL is indicated in the U.S. for the treatment of:.

2021年11月。REBLOZYL在美国用于治疗:。

anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

需要定期输注红细胞(RBC)的成人β地中海贫血患者的贫血。

anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.

对于可能需要定期输注红细胞(RBC)的极低至中等风险骨髓增生异常综合征(MDS)的成年患者,没有使用过促红细胞生成剂(ESA-naïve)的贫血。

anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T)..

患有极低至中等风险骨髓增生异常综合征并伴有环状铁粒幼细胞(MDS-RS)或伴有环状铁粒幼细胞和血小板增多症(MDS/MPN-RS-T)的骨髓增生异常/骨髓增生性肿瘤的成年患者,贫血不能刺激红细胞生成,需要8周以上的2个或更多红细胞(RBC)单位。。

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia. In the U.S., REBLOZYL is not indicated for use in patients with non-transfusion-dependent beta thalassemia.

REBLOZYL不适用于需要立即纠正贫血的患者的红细胞输注替代品。在美国,雷布唑不适用于非输血依赖性β地中海贫血患者。

U.S. Important Safety Information

U、 美国重要安全信息

WARNINGS AND PRECAUTIONS

警告和注意事项

Thrombosis/Thromboembolism

血栓形成/血栓栓塞

In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) of REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions.

在患有β地中海贫血的成年患者中,8/223(3.6%)的雷布唑治疗患者报告了血栓栓塞事件(TEE)。TEE包括深静脉血栓形成,肺栓塞,门静脉血栓形成和缺血性中风。已知血栓栓塞危险因素(脾切除术或同时使用激素替代疗法)的患者可能会进一步增加血栓栓塞的风险。

Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly..

考虑对TEE风险增加的患者进行血栓预防。监测患者血栓栓塞事件的体征和症状,并及时进行治疗。。

Hypertension

高血压

Hypertension was reported in 11.4% (63/554) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 2% to 9.6%. In patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (SBP) ≥130 mm Hg and 33 (16.6%) patients developed diastolic blood pressure (DBP) ≥80 mm Hg.

据报道,接受雷布唑治疗的患者中有11.4%(63/554)患有高血压。在整个临床研究中,3至4级高血压的发生率为2%至9.6%。在基线血压正常的β地中海贫血患者中,13例(6.2%)患者出现收缩压(SBP)≥130 mm Hg,33例(16.6%)患者出现舒张压(DBP)≥80 mm Hg。

In ESA-refractory or -intolerant adult patients with MDS with normal baseline blood pressure, 26 (30%) patients developed SBP ≥130 mm Hg and 23 (16%) patients developed DBP ≥80 mm Hg. In ESA-naïve adult patients with MDS with normal baseline blood pressure, 23 (36%) patients developed SBP ≥140 mm Hg and 11 (6%) patients developed DBP ≥80 mm Hg.

在基线血压正常的ESA难治性或不耐受性MDS成年患者中,26例(30%)患者发生SBP≥130 mm Hg,23例(16%)患者发生DBP≥80 mm Hg。在基线血压正常的ESA初治MDS成年患者中,23例(36%)患者SBP≥140 mm Hg,11例(6%)患者DBP≥80 mm Hg。

Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents..

每次给药前监测血压。使用抗高血压药物管理先前存在的高血压的新发或恶化。。

Extramedullary Hematopoietic (EMH) Masses

髓外造血(EMH)肿块

In adult patients with transfusion-dependent beta thalassemia, EMH masses were observed in 3.2% of REBLOZYL-treated patients, with spinal cord compression symptoms due to EMH masses occurring in 1.9% of patients (BELIEVE and REBLOZYL long-term follow-up study).

在输血依赖性β地中海贫血的成年患者中,在接受REBLOZYL治疗的患者中有3.2%观察到EMH肿块,在1.9%的患者中出现了由于EMH肿块引起的脊髓压迫症状(Belied和REBLOZYL长期随访研究)。

In a study of adult patients with non-transfusion-dependent beta thalassemia, a higher incidence of EMH masses was observed in 6.3% of REBLOZYL-treated patients vs. 2% of placebo-treated patients in the double-blind phase of the study, with spinal cord compression due to EMH masses occurring in 1 patient with a prior history of EMH.

在一项针对非输血依赖性β地中海贫血成年患者的研究中,在研究的双盲阶段,6.3%的雷布唑治疗患者的EMH肿块发生率高于2%的安慰剂治疗患者,其中1例有EMH病史的患者因EMH肿块导致脊髓受压。

REBLOZYL is not indicated for use in patients with non-transfusion-dependent beta thalassemia..

REBLOZYL不适用于非输血依赖性β地中海贫血患者。。

Possible risk factors for the development of EMH masses in patients with beta thalassemia include history of EMH masses, splenectomy, splenomegaly, hepatomegaly, or low baseline hemoglobin (<8.5 g/dL). Signs and symptoms may vary depending on the anatomical location. Monitor patients with beta thalassemia at initiation and during treatment for symptoms and signs or complications resulting from the EMH masses and treat according to clinical guidelines.

β地中海贫血患者发生EMH肿块的可能危险因素包括EMH肿块史,脾切除术,脾肿大,肝肿大或基线血红蛋白低(<8.5 g/dL)。体征和症状可能因解剖位置而异。在开始和治疗期间监测β地中海贫血患者的EMH肿块引起的症状和体征或并发症,并根据临床指南进行治疗。

Discontinue treatment with REBLOZYL in case of serious complications due to EMH masses. Avoid use of REBLOZYL in patients requiring treatment to control the growth of EMH masses..

如果由于EMH肿块引起严重并发症,请停止使用雷布唑治疗。避免在需要治疗以控制EMH肿块增长的患者中使用雷布唑。。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose..

雷布唑给孕妇服用时可能会对胎儿造成伤害。在怀孕的大鼠和兔子研究中,REBLOZYL导致植入后损失增加,产仔数减少,骨骼变异发生率增加。告知孕妇对胎儿的潜在风险。建议有生殖潜力的女性在治疗期间和最终剂量后至少3个月内使用有效的避孕措施。。

ADVERSE REACTIONS

不良反应

Beta-Thalassemia

β地中海贫血

Serious adverse reactions occurred in 3.6% of patients on REBLOZYL. Serious adverse reactions occurring in 1% of patients included cerebrovascular accident and deep vein thrombosis. A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML)..

3.6%的患者服用雷布唑后出现严重不良反应。1%的患者发生严重不良反应,包括脑血管意外和深静脉血栓形成。1名接受雷布唑治疗的患者发生致命不良反应,该患者因未确诊的急性髓细胞白血病(AML)病例而死亡。。

Most common adverse reactions (at least 10% for REBLOZYL and 1% more than placebo) were headache (26% vs 24%), bone pain (20% vs 8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs 11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and dizziness (11% vs 5%).

最常见的不良反应(REBLOZYL至少10%,比安慰剂多1%)是头痛(26%比24%),骨痛(20%比8%),关节痛(19%比12%),疲劳(14%比13%),咳嗽(14%比11%),腹痛(14%比12%),腹泻(12%比10%)和头晕(11%比5%)。

ESA-naïve adult patients with Myelodysplastic Syndromes

ESA初治的成人骨髓增生异常综合征患者

Grade ≥3 (≥2%) adverse reactions included hypertension and dyspnea.

≥3级(≥2%)不良反应包括高血压和呼吸困难。

The most common (≥10%) all-grade adverse reactions included diarrhea, fatigue, hypertension, peripheral edema, nausea, and dyspnea.

最常见(≥10%)的所有级别不良反应包括腹泻,疲劳,高血压,外周水肿,恶心和呼吸困难。

ESA-refractory or -intolerant adult patients with Myelodysplastic Syndromes

ESA难治性或不耐受性成人骨髓增生异常综合征患者

Grade ≥3 (≥2%) adverse reactions included fatigue, hypertension, syncope and musculoskeletal pain. A fatal adverse reaction occurred in 5 (2.1%) patients.

≥3级(≥2%)不良反应包括疲劳,高血压,晕厥和肌肉骨骼疼痛。5例(2.1%)患者发生致命不良反应。

The most common (≥10%) adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection.

最常见(≥10%)的不良反应包括疲劳,肌肉骨骼疼痛,头晕,腹泻,恶心,超敏反应,高血压,头痛,上呼吸道感染,支气管炎和尿路感染。

LACTATION

哺乳期

It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment.

目前尚不清楚雷布唑是排泄到母乳中还是在哺乳期婴儿摄入后被全身吸收。在泌乳大鼠的乳汁中检测到REBLOZYL。当药物存在于动物乳中时,很可能药物会存在于人乳中。由于许多药物是从母乳中排出的,并且由于雷布唑对婴儿的影响未知,因此应决定是停止护理还是停止治疗。

Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose..

由于母乳喂养的孩子可能会产生严重的不良反应,因此不建议在治疗期间和最后一次给药后3个月内进行母乳喂养。。

DRUG ABUSE POTENTIAL

药物滥用潜力

Abuse: Abuse of REBLOZYL may be seen in athletes for the effects on erythropoiesis. Misuse of drugs that increase erythropoiesis, such as REBLOZYL, by healthy persons may lead to polycythemia, which may be associated with life-threatening cardiovascular complications.

滥用:运动员中可能会出现滥用雷布唑对红细胞生成的影响。健康人滥用增加红细胞生成的药物,如雷布唑,可能导致红细胞增多症,这可能与危及生命的心血管并发症有关。

Please see accompanying U.S. Full Prescribing Information for REBLOZYL.

请参阅随附的REBLOZYL美国完整处方信息。

Bristol Myers Squibb: Creating a Better Future for People with Cancer

百时美施贵宝:为癌症患者创造更美好的未来

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus.

百时美施贵宝的灵感来自一个单一的愿景——通过科学改变患者的生活。该公司癌症研究的目标是提供药物,为每位患者提供更好、更健康的生活,并使治愈成为可能。百时美施贵宝(Bristol-Myers Squibb)的研究人员正在探索个性化医学的新前沿,并通过创新的数字平台,将数据转化为见解,从而提高他们的关注度。

Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle..

对因果人类生物学的深刻理解、尖端能力和差异化研究平台使该公司能够从各个角度处理癌症。。

Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future..

癌症可以无情地影响患者生活的许多方面,百时美施贵宝致力于采取行动解决护理的各个方面,从诊断到生存。作为癌症治疗领域的领导者,百时美施贵宝正在努力让所有癌症患者拥有更好的未来。。

About Bristol Myers Squibb

关于百时美施贵宝

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram..

百时美施贵宝是一家全球生物制药公司,其使命是发现、开发和提供创新药物,帮助患者战胜严重疾病。有关百时美施贵宝的更多信息,请访问BMS.com或在LinkedIn、Twitter、YouTube、Facebook和Instagram上关注我们。。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性声明的警示声明

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的“前瞻性声明”,其中涉及药品的研究、开发和商业化。所有不属于历史事实陈述的陈述都是或可能被视为前瞻性陈述。

Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements.

此类前瞻性陈述基于对我们未来财务业绩、目标、计划和目标的当前预期和预测,涉及固有风险、假设和不确定性,包括可能在未来几年延迟、转移或改变其中任何一个的难以预测的内部或外部因素,可能超出我们的控制范围,并可能导致我们未来的财务结果、目标、计划和目标与报表中表达或暗示的财务结果、目标、计划和目标存在重大差异。

These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that the product candidate described in this release may not receive regulatory approval for the indications described in this release, that any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such product candidate for such indications will be commercially successful.

这些风险、假设、不确定性和其他因素包括,未来的研究结果可能与迄今为止的结果不一致,本版本中描述的候选产品可能未获得本版本中描述的适应症的监管批准,任何营销批准(如果授予)可能对其使用有重大限制,如果获得批准,此类适应症的候选产品是否会取得商业成功。

No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2022, as updated by our subsequent Quarterly .

不能保证前瞻性声明。本新闻稿中的前瞻性陈述应与影响百时美施贵宝业务和市场的许多风险和不确定性一起进行评估,特别是在百时美施贵宝截至2022年12月31日的年度报告10-K表中的警示声明和风险因素讨论中确定的风险和不确定性,并由我们随后的季度更新。

corporatefinancial-news

企业财经新闻