BLINCYTO® Added to Multiphase Consolidation Chemotherapy Reduced Risk of Death by 58% Showing Superior Overall Survival Versus Chemotherapy Alone

BLINCYTO®加入多期巩固化疗可将死亡风险降低58%，与单独化疗相比，总体生存率更高

First and Only Bispecific T-cell Engager (BiTE®) Therapy for Consolidation Treatment Regardless of Measurable Residual Disease (MRD) Status

无论可测量的残留疾病（MRD）状态如何，第一个也是唯一一个用于巩固治疗的双特异性T细胞接受者（BiTE®）疗法

THOUSAND OAKS, Calif., June 14, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved BLINCYTO® (blinatumomab) for the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status..

加利福尼亚州千橡，2024年6月14日/美国新闻通讯社/--Amgen（纳斯达克：AMGN）今天宣布，美国食品和药物管理局（FDA）已批准BLINCYTO®（blinatumomab）用于治疗CD19阳性费城染色体阴性B细胞前体急性淋巴细胞白血病（B-ALL）处于巩固期的一个月或一个月以上的成人和儿科患者，无论可测量的残留病（MRD）状态如何。。

'B-ALL is an aggressive blood cancer with enduring high unmet need. BLINCYTO has helped thousands of patients with B-ALL over the last 10 years. Today's approval in the frontline consolidation phase, regardless of MRD status, allows us to reach more patients than ever with this transformative, first-in-class Bispecific T-cell Engager (BiTE®) therapy,' said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen..

“B-ALL是一种侵袭性血癌，持续存在大量未满足的需求。在过去的10年中，BLINCYTO已经帮助了数千名B-ALL患者。Amgen负责研发的执行副总裁兼首席科学官杰伊·布拉德纳（JayBradner）医学博士说，无论MRD状态如何，今天在一线巩固阶段的批准都使我们能够通过这种变革性的一流双特异性T细胞接受者（BiTE®）疗法接触到比以往更多的患者。。

The approval marks the third indication for BLINCYTO and is based primarily on the Phase 3 E1910 clinical trial led by ECOG-ACRIN Cancer Research Group that studied patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving postinduction consolidation treatment, which aims to deepen remission to achieve durable responses.

该批准标志着BLINCYTO的第三个适应症，主要基于ECOG-ACRIN癌症研究小组领导的3期E1910临床试验，该试验研究了新诊断的费城染色体阴性B-ALL患者接受诱导后巩固治疗，旨在加深缓解以实现持久的反应。

Study results demonstrated that BLINCYTO added to multiphase consolidation chemotherapy showed superior overall survival (OS) versus chemotherapy alone. The 3-year OS was 84.8% in the BLINCYTO plus chemotherapy arm (n=112) and 69% in the chemotherapy arm (n=112), with the hazard ratio for OS of 0.42.

研究结果表明，与单独化疗相比，加入多期巩固化疗的BLINCYTO显示出更好的总生存期（OS）。BLINCYTO加化疗组（n=112）的3年OS为84.8%，化疗组（n=112）为69%，OS风险比为0.42。

With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the BLINCYTO plus chemotherapy arm and 62.5% in the chemotherapy arm..

中位随访时间为4.5年，BLINCYTO加化疗组的5年OS为82.4%，化疗组为62.5%。。

'In the E1910 study, blinatumomab reduced risk of death and showed a remarkable improvement in overall survival,' said Selina M. Luger, M.D., professor of hematology-oncology at the University of Pennsylvania's Perelman School of Medicine and Abramson Cancer Center, chair of the ECOG-ACRIN Leukemia Committee and an investigator on the study.

宾夕法尼亚大学佩雷尔曼医学院和艾布拉姆森癌症中心血液肿瘤学教授、ECOG-ACRIN白血病委员会主席、该研究的研究员SelinaM.Luger医学博士说：“在E1910研究中，blinatumomab降低了死亡风险，并显着改善了总生存率。”。

'This approval redefines the standard of care for patients with B-ALL and provides them with a more effective treatment option than standard chemotherapy alone.'.

“这项批准重新定义了B-ALL患者的护理标准，并为他们提供了比单独使用标准化疗更有效的治疗选择。”。

'The risk of B-ALL recurrence after the initial phase of treatment is relatively high, making this approval for patients noteworthy,' said E. Anders Kolb, M.D., president and chief executive officer of The Leukemia & Lymphoma Society. 'B-ALL is the most common type of ALL and having another effective option available earlier in a patient's treatment journey is critical for clinicians who are working to give these patients more time with their loved ones.'.

白血病与淋巴瘤协会（Leukemia&Lymphoma Society）总裁兼首席执行官安德斯·科尔布（E.AndersKolb）医学博士说，B-ALL在治疗初期复发的风险相对较高，因此对患者的批准值得注意B-ALL是最常见的ALL类型，在患者治疗过程的早期有另一种有效的选择对于正在努力给这些患者更多时间与亲人在一起的临床医生至关重要。”。

The E1910 study was designed and conducted independently from industry. ECOG-ACRIN sponsored the trial with public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Other NCI-funded network groups took part in the study. In addition, Amgen provided BLINCYTO and support through an NCI Cooperative Research and Development Agreement..

E1910研究是独立于行业设计和进行的。ECOG-ACRIN由美国国立卫生研究院（NIH）下属的国家癌症研究所（NCI）提供公共资金赞助该试验。其他由NCI资助的网络组织也参与了这项研究。此外，安进还通过NCI合作研发协议为BLINCYTO提供了支持。。

About Acute Lymphoblastic Leukemia (ALL)ALL, also known as acute lymphoblastic leukemia, is a fast-growing type of blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. ALL is a rare disease, with 6,540 new cases diagnosed in the U.S.

关于急性淋巴细胞白血病（ALL）ALL，也称为急性淋巴细胞白血病，是一种快速增长的血癌，在骨髓中发展，有时可以扩散到身体的其他部位，包括淋巴结，肝脏，脾脏和中枢神经系统。ALL是一种罕见疾病，在美国诊断出6540例新病例。

in 2023 affecting both children and adults.1 B-ALL begins in immature cells that would normally develop into B-cell lymphocytes, which are white blood cells that grow in bone marrow.2,3 B-ALL is the most common type of ALL, constituting approximately 75% of cases in adults.4 .

2023年影响儿童和成人[1]。B-ALL始于未成熟细胞，通常会发育成B细胞淋巴细胞，即在骨髓中生长的白细胞[2,3]。B-ALL是最常见的ALL类型，约占成人病例的75%。

About BLINCYTO® (blinatumomab)BLINCYTO is the first globally approved BiTE® immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE® molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells.

关于BLINCYTO®（blinatumomab）BLINCYTO是第一个全球批准的针对B细胞上CD19表面抗原的BiTE®免疫肿瘤学疗法。BiTE®分子通过将T细胞（一种能够杀死其他被视为威胁的细胞的白细胞）与癌细胞结合，帮助人体免疫系统检测和靶向恶性细胞，从而对抗癌症。

By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE® immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers..

通过将T细胞带到癌细胞附近，T细胞可以注射毒素并引发癌细胞死亡（细胞凋亡）。BiTE®免疫肿瘤学疗法目前正在研究其治疗多种癌症的潜力。。

BLINCYTO was granted breakthrough therapy and Priority Review designations by the U.S. FDA and is approved in the U.S. for the treatment of:

BLINCYTO获得了美国的突破性治疗和优先审查指定。S、 FDA并在美国获得批准。S、 用于治疗：

Adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-ALL during the consolidation phase of multiphase therapy.

在多期治疗的巩固阶段，一个月或一个月以上CD19阳性费城染色体阴性B-ALL的成人和儿科患者。

CD19-positive B-ALL in first or second complete remission with MRD greater than or equal to 0.1% in adults and pediatric patients one month or older.

在一个月或一个月以上的成人和儿科患者中，CD19阳性B-ALL在第一次或第二次完全缓解时MRD大于或等于0.1%。

Relapsed or refractory CD19-positive B-ALL in adults and pediatric patients one month or older.

成人和一个月以上的儿科患者复发或难治性CD19阳性B-ALL。

In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of:

在欧盟（EU），BLINCYTO被指定为单一疗法，用于治疗：

Adults with Philadelphia chromosome-negative CD19-positive relapsed or refractory B-ALL. Patients with Philadelphia chromosome-positive B-ALL should have failed treatment with at least two tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.

费城染色体阴性CD19阳性的成年人复发或难治性B-ALL。费城染色体阳性B-ALL患者应使用至少两种酪氨酸激酶抑制剂（TKIs）治疗失败，并且没有其他治疗选择。

Adults with Philadelphia chromosome-negative CD19-positive B-ALL in first or second complete remission with MRD greater than or equal to 0.1%.

。

Pediatric patients aged 1 year or older with Philadelphia chromosome-negative CD19-positive B-ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.

费城染色体阴性CD19阳性B-ALL的1岁或以上儿科患者，在接受至少两次先前的治疗后难治或复发，或在接受先前的异基因造血干细胞移植后复发。

Pediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome-negative CD19-positive B-ALL as part of the consolidation therapy.

作为巩固治疗的一部分，年龄在1岁或以上的高危首次复发费城染色体阴性CD19阳性B-ALL的儿科患者。

INDICATIONS

适应症

BLINCYTO® (blinatumomab) is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older with:

BLINCYTO®（blinatumomab）适用于治疗一个月及以上的成人和儿科患者的CD19阳性B细胞前体急性淋巴细胞白血病（ALL）：

Philadelphia chromosome-negative disease in the consolidation phase of multiphase chemotherapy.

多期化疗巩固期的费城染色体阴性疾病。

Minimal residual disease (MRD) greater than or equal to 0.1% in first or second complete remission.

在第一次或第二次完全缓解时，最小残留病（MRD）大于或等于0.1%。

Relapsed or refractory disease.

复发或难治性疾病。

BLINCYTO® IMPORTANT SAFETY INFORMATION

BLINCYTO®重要安全信息

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

警告：细胞因子释放综合征和神经毒性，包括免疫效应细胞相关神经毒性综合征

Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® and treat with corticosteroids as recommended.

接受BLINCYTO®治疗的患者发生细胞因子释放综合征（CRS），可能危及生命或致命。中断或停止BLINCYTO®并按建议使用皮质类固醇治疗。

Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS) which may be severe, life-threatening, or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® as recommended.

接受BLINCYTO®治疗的患者发生神经毒性，包括可能严重，危及生命或致命的免疫效应细胞相关神经毒性综合征（ICANS）。按照建议中断或停止BLINCYTO®。

Contraindications

禁忌症

BLINCYTO® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.

BLINCYTO®禁用于已知对blinatumomab或产品配方的任何成分过敏的患者。

Warnings and Precautions

警告和注意事项

Cytokine Release Syndrome (CRS): CRS, which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. The median time to onset of CRS is 2 days after the start of infusion and the median time to resolution of CRS was 5 days among cases that resolved. Closely monitor and advise patients to contact their healthcare professional for signs and symptoms of serious adverse events such as fever, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), and disseminated intravascular coagulation (DIC).

。CRS发作的中位时间为输注开始后2天，CRS消退的中位时间为5天。密切监测并建议患者联系其医疗保健专业人员，以了解严重不良事件的体征和症状，例如发烧，头痛，恶心，虚弱，低血压，丙氨酸氨基转移酶（ALT）升高，天冬氨酸氨基转移酶（AST）升高，总胆红素（TBILI）升高和弥散性血管内凝血（DIC）。

The manifestations of CRS after treatment with BLINCYTO® overlap with those of infusion reactions, capillary leak syndrome (CLS), and hemophagocytic histiocytosis/macrophage activation syndrome (MAS). Using all of these terms to define CRS in clinical trials of BLINCYTO®, CRS was reported in 15% of patients with R/R ALL, in 7% of patients with MRD-positive ALL, and in 16% of patients receiving BLINCYTO® cycles in the consolidation phase of therapy.

BLINCYTO®治疗后CRS的表现与输注反应，毛细血管渗漏综合征（CLS）和噬血细胞组织细胞增生/巨噬细胞活化综合征（MAS）的表现重叠。在BLINCYTO®的临床试验中使用所有这些术语来定义CRS，在15%的R/R all患者，7%的MRD阳性all患者和16%的接受BLINCYTO®周期的患者中报告了CRS治疗巩固阶段。

If severe CRS occurs, interrupt BLINCYTO® until CRS resolves. Discontinue BLINCYTO® permanently if life-threatening CRS occurs. Administer corticosteroids for severe or life-threatening CRS..

如果发生严重的CRS，中断BLINCYTO®直到CRS解决。如果发生危及生命的CRS，请永久停止BLINCYTO®。对严重或危及生命的CRS服用皮质类固醇。。

Neurological Toxicities, including Immune Effector Cell-Associated Neurotoxicity Syndrome: BLINCYTO® can cause serious or life-threatening neurologic toxicity, including ICANS. The incidence of neurologic toxicities in clinical trials was approximately 65%. The median time to the first event was within the first 2 weeks of BLINCYTO® treatment.

神经毒性，包括免疫效应细胞相关神经毒性综合征：BLINCYTO®可引起严重或危及生命的神经毒性，包括ICAN。临床试验中神经系统毒性的发生率约为65%。第一次事件的中位时间在BLINCYTO®治疗的前2周内。

The most common (≥ 10%) manifestations of neurological toxicity were headache and tremor. Grade 3 or higher neurological toxicities occurred in approximately 13% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders.

。大约13%的患者发生3级或更高的神经系统毒性，包括脑病，抽搐，言语障碍，意识障碍，困惑和定向障碍以及协调和平衡障碍。

Manifestations of neurological toxicity included cranial nerve disorders. The majority of neurologic toxicities resolved following interruption of BLINCYTO®, but some resulted in treatment discontinuation.  The incidence of signs and symptoms consistent with ICANS in clinical trials was 7.5%. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.

神经毒性的表现包括颅神经疾病。BLINCYTO®中断后，大多数神经系统毒性得到解决，但有些导致治疗中断。临床试验中与ICANS一致的体征和症状发生率为7.5%。在CRS解决后或在没有CRS的情况下，ICAN的发作可以与CRS同时发生。

There is limited experience with BLINCYTO® in patients with active ALL in the central nervous system (CNS) or a history of neurologic events. Patients with a history or presence of clinically relevant CNS pathology were excluded from clinical studies. Patients with Down Syndrome over the age of 10 years may have a higher risk of seizures with BLINCYTO® therapy.Monitor patients for signs and symptoms of neurological toxicities, including ICANS, and interrupt or discontinue BLINCYTO® as outlined in the PI.

BLINCYTO®治疗中枢神经系统（CNS）活动性ALL或有神经系统事件史的患者的经验有限。有临床相关CNS病理史或存在临床相关CNS病理的患者被排除在临床研究之外。BLINCYTO®治疗10岁以上的唐氏综合症患者可能有较高的癫痫发作风险。监测患者的神经毒性体征和症状，包括ICAN，并按照PI中的概述中断或停止BLINCYTO®。

Advise outpatients to contact their healthcare professional if they develop signs or symptoms of neurological toxicities..

建议门诊患者如果出现神经系统毒性的体征或症状，请联系他们的医疗保健专业人员。。

Infections: Approximately 25% of patients receiving BLINCYTO® in clinical trials experienced serious infections such as sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment.

感染：在临床试验中接受BLINCYTO®治疗的患者中，约有25%经历了严重感染，如败血症、肺炎、菌血症、机会性感染和导管部位感染，其中一些感染危及生命或致命。在治疗期间酌情使用预防性抗生素并进行监测测试。

Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO® as needed..

监测患者的感染体征或症状，并进行适当治疗，包括根据需要中断或停用BLINCYTO®。。

Tumor Lysis Syndrome (TLS), which may be life-threatening or fatal, has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on-treatment hydration, should be used during BLINCYTO® treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO® as needed to manage these events..

已经观察到可能危及生命或致命的肿瘤溶解综合征（TLS）。BLINCYTO®治疗期间应采取预防措施，包括预处理无毒细胞减少和治疗水合作用。监测患者的TLS体征和症状，并根据需要中断或停止BLINCYTO®以管理这些事件。。

Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters (including, but not limited to, white blood cell count and absolute neutrophil count) during BLINCYTO® infusion and interrupt BLINCYTO® if prolonged neutropenia occurs..

已经观察到中性粒细胞减少症和发热性中性粒细胞减少症，包括危及生命的病例。在BLINCYTO®输注期间监测适当的实验室参数（包括但不限于白细胞计数和绝对中性粒细胞计数），如果发生长期中性粒细胞减少症，则中断BLINCYTO®。。

Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures and ICANS, patients receiving BLINCYTO® are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO® is being administered..

对驾驶和使用机器能力的影响：由于可能发生神经系统事件，包括癫痫发作和ICAN，接受BLINCYTO®治疗的患者有意识丧失的风险，应建议患者在服用BLINCYTO®时不要驾驶和从事危险职业或活动，例如操作重型或潜在危险的机器。。

Elevated Liver Enzymes: Transient elevations in liver enzymes have been associated with BLINCYTO® treatment with a median time to onset of 3 days. In patients receiving BLINCYTO®, although the majority of these events were observed in the setting of CRS, some cases of elevated liver enzymes were observed outside the setting of CRS, with a median time to onset of 19 days.

肝酶升高：肝酶的短暂升高与BLINCYTO®治疗有关，中位发病时间为3天。在接受BLINCYTO®的患者中，尽管大多数这些事件是在CRS的情况下观察到的，但在CRS的情况下观察到一些肝酶升高的病例，中位发病时间为19天。

Grade 3 or greater elevations in liver enzymes occurred in approximately 7% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase, and total blood bilirubin prior to the start of and during BLINCYTO® treatment.

在CRS之外，大约7%的患者肝酶升高3级或更高，导致不到1%的患者停止治疗。在BLINCYTO®治疗开始之前和期间监测ALT，AST，γ-谷氨酰转移酶和总血胆红素。

BLINCYTO® treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if total bilirubin rises to > 3 times ULN..

如果转氨酶升高至正常上限（ULN）的5倍以上或总胆红素升高至ULN的3倍以上，则应中断BLINCYTO®治疗。。

Pancreatitis: Fatal pancreatitis has been reported in patients receiving BLINCYTO® in combination with dexamethasone in clinical trials and the post-marketing setting. Evaluate patients who develop signs and symptoms of pancreatitis and interrupt or discontinue BLINCYTO® and dexamethasone as needed..

胰腺炎：据报道，在临床试验和上市后环境中，接受BLINCYTO®联合地塞米松治疗的患者患有致命性胰腺炎。评估出现胰腺炎体征和症状并根据需要中断或停用BLINCYTO®和地塞米松的患者。。

Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO®, especially in patients previously treated with cranial irradiation and antileukemic chemotherapy.

白质脑病：尽管临床意义尚不清楚，但在接受BLINCYTO®治疗的患者中，尤其是先前接受过头颅照射和抗白血病化疗的患者中，观察到了显示白质脑病的头颅磁共振成像（MRI）变化。

Preparation and administration errors have occurred with BLINCYTO® treatment. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose).

BLINCYTO®治疗出现了制备和给药错误。严格遵循PI中的准备（包括混合）和给药说明，以最大程度地减少用药错误（包括剂量不足和过量）。

Immunization: Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of BLINCYTO® treatment, during treatment, and until immune recovery following last cycle of BLINCYTO®.

免疫接种：在BLINCYTO®治疗开始前，治疗期间以及BLINCYTO®最后一个周期后的免疫恢复之前，至少2周内不建议接种活病毒疫苗。

Benzyl Alcohol Toxicity in Neonates: Serious adverse reactions, including fatal reactions and the 'gasping syndrome,' have been reported in very low birth weight (VLBW) neonates born weighing less than 1500 g, and early preterm neonates (infants born less than 34 weeks gestational age) who received intravenous drugs containing benzyl alcohol as a preservative.

新生儿苯甲醇毒性：据报道，出生体重低于1500克的极低出生体重（VLBW）新生儿和早产新生儿（出生小于34周的婴儿）出现严重不良反应，包括致命反应和“喘息综合征”），他们接受了含有苯甲醇作为防腐剂的静脉注射药物。

Early preterm VLBW neonates may be more likely to develop these reactions, because they may be less able to metabolize benzyl alcohol.Use the preservative-free preparations of BLINCYTO® where possible in neonates. When prescribing BLINCYTO® (with preservative) for neonatal patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO® (with preservative), other products containing benzyl alcohol or other excipients (e.g., ethanol, propylene glycol) which compete with benzyl alcohol for the same metabolic pathway.Monitor neonatal patients receiving BLINCYTO® (with preservative) for new or worsening metabolic acidosis.

早期早产VLBW新生儿可能更容易发生这些反应，因为他们可能不太能够代谢苯甲醇。尽可能在新生儿中使用BLINCYTO®的无防腐剂制剂。当为新生儿患者开具BLINCYTO®（含防腐剂）时，请考虑来自所有来源的苯甲醇的每日综合代谢负荷，包括BLINCYTO®（含防腐剂），其他含有苯甲醇或其他赋形剂（例如乙醇，丙二醇）的产品，它们与苯甲醇竞争相同的代谢途径。监测接受BLINCYTO®（含防腐剂）治疗的新生儿患者是否出现新的或恶化的代谢性酸中毒。

The minimum amount of benzyl alcohol at which serious adverse reactions may occur in neonates is not known. The BLINCYTO® 7-Day bag (with preservative) contains 7.4 mg of benzyl alcohol per mL..

新生儿可能发生严重不良反应的苯甲醇的最小量尚不清楚。BLINCYTO®7天袋（含防腐剂）每毫升含有7.4毫克苯甲醇。。

Embryo-Fetal Toxicity: Based on its mechanism of action, BLINCYTO® may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with BLINCYTO® and for 48 hours after the last dose..

胚胎-胎儿毒性：根据其作用机制，BLINCYTO®给孕妇服用时可能会造成胎儿伤害。告知孕妇对胎儿的潜在风险。建议有生殖潜力的女性在使用BLINCYTO®治疗期间和最后一剂后48小时内使用有效的避孕措施。。

Adverse Reactions

不良反应

The safety of BLINCYTO® in adult and pediatric patients one month and older with MRD-positive B-cell precursor ALL (n=137), relapsed or refractory B-cell precursor ALL (n=267), and Philadelphia chromosome-negative B cell precursor ALL in consolidation (n=165) was evaluated in clinical studies. The most common adverse reactions (≥ 20%) to BLINCYTO® in this pooled population were pyrexia, infusion-related reactions, headache, infection, musculoskeletal pain, neutropenia, nausea, anemia, thrombocytopenia, and diarrhea..

。在这个汇集的人群中，BLINCYTO®最常见的不良反应（≥20%）是发热，输液相关反应，头痛，感染，肌肉骨骼疼痛，中性粒细胞减少症，恶心，贫血，血小板减少症和腹泻。。

Dosage and Administration Guidelines

剂量和给药指南

BLINCYTO® is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm.

BLINCYTO®使用输液泵以恒定流速连续静脉输注，输液泵应可编程，可锁定，非弹性，并具有警报。

It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).

严格遵守完整处方信息中提供的准备（包括混合）和给药说明，以最大程度地减少用药错误（包括剂量不足和过量），这一点非常重要。

Please see BLINCYTO® full Prescribing Information, including BOXED WARNINGS.

请参阅BLINCYTO®完整的处方信息，包括盒装警告。

About BiTE® TechnologyBispecific T-cell Engager (BiTE®) technology is a targeted immuno-oncology platform that is designed to engage patient's own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE® immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens.

关于BiTE®技术特异性T细胞接合器（BiTE®）技术是一种靶向免疫肿瘤学平台，旨在使患者自身的T细胞与任何肿瘤特异性抗原结合，激活T细胞的细胞毒性潜力以消除可检测的癌症。BiTE®免疫肿瘤学平台有可能通过肿瘤特异性抗原治疗不同的肿瘤类型。

The BiTE® platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing multiple BiTE® molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE® technology with the goal of enhancing patient experience and therapeutic potential.

BiTE®平台的目标是产生现成的解决方案，这些解决方案有可能在患者需要时为所有提供者提供创新的T细胞治疗。安进正在推动多种BiTE®分子跨越广泛的血液恶性肿瘤和实体瘤，进一步研究BiTE®技术，以提高患者体验和治疗潜力。

To learn more about BiTE® technology, visit https://www.amgenoncology.com/bite-platform.html..

要了解有关BiTE®技术的更多信息，请访问https://www.amgenoncology.com/bite-platform.html..

About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.

关于安进安进安进发现、开发、制造和提供创新药物，以帮助数百万患者对抗世界上一些最严重的疾病。40多年前，安进（Amgen）帮助建立了生物技术产业，并一直处于创新的前沿，利用技术和人类基因数据超越了当今已知的领域。

Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.  .

安进正在推进一条广泛而深入的管道，该管道以其现有的药物组合为基础，用于治疗癌症、心脏病、骨质疏松症、炎症性疾病和罕见疾病。。

In 2024, Amgen was named one of the 'World's Most Innovative Companies' by Fast Company and one of 'America's Best Large Employers' by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. .

2024年，安进被Fast Company评为“世界上最具创新性的公司”之一，被福布斯评为“美国最佳大型雇主”之一，以及其他外部认可。安进是道琼斯工业平均指数（Dow Jones Industrial Average®）的30家公司之一，也是纳斯达克100指数（Nasdaq-100 Index®）的一部分，该指数包括根据市值在纳斯达克股票市场上市的最大和最具创新性的非金融公司。。

For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, TikTok, YouTube and Threads.

有关更多信息，请访问Amgen.com，在X、LinkedIn、Instagram、TikTok、YouTube和Threads上关注安进。

Amgen Forward-Looking StatementsThis news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd.

安进前瞻性声明本新闻稿包含基于安进当前期望和信念的前瞻性声明。除历史事实陈述外，所有陈述均为可被视为前瞻性陈述的陈述，包括与任何其他公司（包括BeiGene，Ltd.）合作或潜在合作的结果、利益和协同作用的任何陈述。

or Kyowa-Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Teneobio, Inc. acquisition, the ChemoCentryx, Inc. acquisition, or the Horizon Therapeutics plc acquisition (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), and any projected impacts from the Horizon acquisition on our acquisition related expenses going forward, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results.

。

Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K.

前瞻性陈述涉及重大风险和不确定性，包括下文讨论的风险和不确定性，以及安进提交的证券交易委员会报告中更详细描述的风险和不确定性，包括我们最近的10-K表年度报告、10-Q表后续任何定期报告以及8-K表当前报告。

Unless otherwise noted, Amgen is providing this .

除非另有说明，安进将提供此服务。

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product.

无法保证前瞻性陈述，实际结果可能与我们预测的结果存在重大差异。无法保证发现或识别新的候选产品或开发现有产品的新适应症，并且不确定从概念到产品的变化；。

Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future.

此外，临床前结果不能保证候选产品在人体内的安全有效性能。计算机或细胞培养系统或动物模型无法完美地模拟人体的复杂性，有时甚至无法充分模拟人体的复杂性。过去，我们完成临床试验并获得产品营销监管批准所需的时间长短各不相同，我们预计未来也会出现类似的变化。

Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship.

即使临床试验成功，监管机构也可能对我们选择的试验终点的批准是否充分提出质疑。我们在内部以及通过许可合作、伙伴关系和合资企业开发候选产品。源自关系的候选产品可能会在双方之间产生争议，或者可能被证明不如我们在建立这种关系时所认为的那样有效或安全。

Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market..

此外，我们或其他人可以在我们的产品（包括我们的设备）上市后发现其安全性、副作用或制造问题。。

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions.

我们的业绩可能会受到以下因素的影响：我们在国内外成功营销新产品和现有产品的能力，涉及当前和未来产品的临床和监管发展，最近推出的产品的销售增长，包括生物仿制药在内的其他产品的竞争，制造我们产品的困难或延误以及全球经济状况。

In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment.

此外，我们产品的销售受到第三方付款人（包括政府、私人保险计划和管理式护理提供者）施加的定价压力、政治和公共审查以及报销政策的影响，并可能受到监管、临床和指南发展以及国内外管理式护理和医疗保健成本控制趋势的影响。

Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities.

此外，我们的研究、测试、定价、营销和其他业务都受到国内外政府监管机构的广泛监管。我们的业务可能会受到政府调查、诉讼和产品责任索赔的影响。此外，我们的业务可能会受到新税法的通过或额外纳税义务的影响。

If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation.

如果我们未能履行我们与美国政府之间的企业诚信协议中的合规义务，我们可能会受到重大制裁。此外，虽然我们经常为我们的产品和技术获得专利，但我们的专利和专利申请所提供的保护可能会受到竞争对手的质疑、无效或规避，或者我们可能无法在当前和未来的知识产权诉讼中胜诉。

We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a .

我们在包括波多黎各在内的几个关键设施进行了大量的商业制造活动，并且还依赖第三方进行生产。

CONTACT: Amgen, Thousand Oaks Elissa Snook, 609-251-1407 (media) Justin Claeys, 805-313-9775 (investors)

联系人：安进，千橡Elissa Snook，609-251-1407（媒体）贾斯汀·克莱斯，805-313-9775（投资者）

Editor's note: Dr. Luger has received honoraria for an Amgen-sponsored educational symposium.

编者按：卢格博士获得了安进赞助的教育研讨会的酬金。

National Cancer Institute. Available at: https://seer.cancer.gov/statfacts/html/alyl.html. Accessed on February 8, 2024.

国家癌症研究所。网址：https://seer.cancer.gov/statfacts/html/alyl.html.2024年2月8日访问。

Terwilliger T, et al. Blood Cancer J. doi:10.1038/bcj.2017.53.

Terwilliger T等人，《血癌杂志》doi:10.1038/bcj.2017.53。

Cancer.org. Available at: https://www.cancer.org/cancer/types/acute-lymphocytic-leukemia/about/what-is-all.html Accessed on February 8, 2024.

Cancer.org。网址：https://www.cancer.org/cancer/types/acute-lymphocytic-leukemia/about/what-is-all.html2024年2月8日访问。

Leukemia & Lymphoma Society. Available at: https://www.lls.org/research/acute-lymphoblastic-leukemia-all#:~:text=B%2DALL%20is%20more%20common,about%2075%20percent%20of%20cases. Accessed on February 8, 2024.

白血病和淋巴瘤协会。网址：https://www.lls.org/research/acute-lymphoblastic-leukemia-all#:~：text=B%2呼叫%20是%20更多常见的，约占%20案例的%2075%20%。2024年2月8日访问。

SOURCE Amgen

来源：安进