Dexamethasone

In the EXCALIBER study, results showed a progression-free survival hazard ratio of 0.49 compared with daratumumab, bortezomib and dexamethasone PRINCETON, N.J.--(BUSINESS WIRE)-- $BMY #Myeloma -- Bristol Myers Squibb Announces ZENBEXUS TM (iberdomide) in Combination with Daratumumab and Dexamethasone (ZDd) Demonstrates Superior Progression-Free Survival vs. Standard of Care in Relapsed and Refractory Multiple Myeloma in Phase 3 EXCALIBER-RRMM Study Bristol Myers Squibb (NYSE: BMY) today announced positive topline results from the Phase 3 EXCALIBER-RRMM study, evaluating ZENBEXUS TM (iberdomide) in combination with daratumumab and dexamethasone (ZDd) in 800 patients with multiple myeloma (MM), as early as first relapse. Results showed ZDd demonstrated a statistically significant improvement in the dual-primary endpoint of progression-free survival (PFS), with median PFS of 42 months for ZDd vs. 20 months for daratumumab, bortezomib and dexamethasone (DVd) [HR:0.49, p<0.000001], representing a 51% reduction in the risk of disease progression or death. Median follow-up was 23 months. The safety pro ZENBEXUS in combination with standard therapies remained consistent with previously reported safety findings from the study. These results build on the previously reported improvement in minimal residual disease (MRD)-negative complete response vs. DVd, the other dual-primary endpoint, which supported the U.S Food and Drug Administration approval of ZENBEXUS for RRMM. Detailed MRD results were presented at the International Myeloma Society 23rd annual meeting and simultaneously published in Lancet Oncology . “The results from EXCALIBER-RRMM reinforce the clinical value of ZENBEXUS in combination with daratumumab and dexamethasone as a treatment approach for relapsed or refractory multiple myeloma, demonstrating the strong benefit observed for minimal residual disease negativity translated to a meaningful improvement in progression free survival for patients,” said Cristian Massacesi, MD , chief medical officer and head of development at Bristol Myers Squibb. “These findings further underscore the value of ZENBEXUS as an effective oral treatment option that can be easily used in diverse care settings, including community settings, where many patients receive their care. We look forward to sharing full results from the study.” This data will be presented at the 68 th Annual Meeting of the American Society of Hematology in New Orleans, L.A. Bristol Myers Squibb thanks the patients and investigators who participated in the EXCALIBER-RRMM clinical trial. About EXCALIBER-RRMM EXCALIBER-RRMM (NCT04975997) is a Phase 3, multicenter, two-stage, randomized, open-label study evaluating the efficacy and safety of ZENBEXUS (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma (RRMM). The study included a dose optimization stage and was designed to assess dual-primary endpoints of minimal residual disease (MRD) negativity and progression-free survival (PFS), with additional secondary endpoints including overall survival (OS), overall response rate (ORR), safety and sustained MRD negativity. Eligible participants included adults with 1 to 2 prior lines of anti-myeloma therapy and progressive disease. The PFS confirmatory analysis population included all 800 patients randomized to ZDd (n=400) or DVd (n=400). Treatment in both arms was administered until disease progression or unacceptable toxicity. Indication ZENBEXUS (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION WARNING: EMBRYO-FETAL TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM EMBRYO-FETAL TOXICITY ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. In females of reproductive potential, obtain 2 negative pregnancy tests before starting ZENBEXUS treatment. Females of reproductive potential must use 2 effective forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after last dose of ZENBEXUS treatment. Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted distribution program called ZENBEXUS REMS. SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM Increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS with daratumumab and hyaluronidase-fihj and dexamethasone. Anti-thrombotic prophylaxis is recommended. CONTRAINDICATIONS Based on the mechanism of action and findings in animal studies, ZENBEXUS can cause birth defects or embryo-fetal death in humans. ZENBEXUS is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus. WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity Females of Reproductive Potential: Must avoid pregnancy while taking ZENBEXUS and for at least 4 weeks after completing therapy. Advise females of reproductive potential of the potential risk to a fetus and to use 2 methods of effective contraception for at least 4 weeks before beginning ZENBEXUS therapy, during therapy, during dose interruptions and for at least 4 weeks after the last dose of ZENBEXUS therapy. Refer patients who can become pregnant to a qualified provider of contraceptive methods, if needed. Two negative pregnancy tests with a sensitivity of at least 25 mIU/mL must be obtained prior to initiating therapy. Pregnancy testing should be performed weekly during the first 4 weeks of treatment. Thereafter, testing should occur every 4 weeks in patients with regular menstrual cycles, or every 2 weeks in patients with irregular menstrual cycles. Females of reproductive potential taking ZENBEXUS must not donate eggs during treatment and for 4 weeks after completion. Males: ZENBEXUS may pass into human semen. Advise patients who can impregnate partners to use effective contraception during treatment and for 4 weeks following the discontinuation of ZENBEXUS therapy. Male patients taking ZENBEXUS must not donate sperm during treatment and for 4 weeks after completion. Blood Donation: Patients must not donate blood during treatment with ZENBEXUS and for 4 weeks following discontinuation of ZENBEXUS therapy. ZENBEXUS REMS ZENBEXUS is available only through a restricted program called ZENBEXUS REMS, because of the risk of embryo-fetal toxicity. Prescribers must be certified with and patients must be enrolled in the ZENBEXUS REMS Program and comply with ongoing monitoring and contraception requirements. Further information about ZENBEXUS REMS, including information for pharmacies, wholesalers, and distributors, is available at or by telephone at 1-888-423-5436. Serious Venous and Arterial Thromboembolism ZENBEXUS can cause serious and life-threatening venous thromboembolic events (DVT and PE) and arterial thromboembolic events (myocardial infarction and stroke). In the EXCALIBER-RRMM study (N=204), venous thromboembolic events occurred in 6.4% of patients treated with ZENBEXUS combined with daratumumab and hyaluronidase-fihj and dexamethasone (IberDd) despite mandatory thromboembolism prophylaxis. The incidence of DVT was 3.4% and the incidence of PE was 1.5%. Arterial thromboembolic events occurred in 3.4% of patients. The incidence of myocardial infarction was 2.0%, and the incidence of stroke (CVA) was 1.5%. Monitor patients for signs and symptoms of thromboembolic events during treatment with ZENBEXUS. Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors. In patients who develop a thromboembolism, interrupt ZENBEXUS and initiate anticoagulant therapy according to guidelines. Neutropenia ZENBEXUS can cause severe neutropenia. In the EXCALIBER-RRMM study, all-grade neutropenia was reported in 90.2%, Grade 3 in 30.9%, and Grade 4 in 53.4% of patients in the IberDd arm. Febrile neutropenia occurred in 5.4% of patients. Monitor complete blood count throughout treatment with ZENBEXUS. Interrupt, reduce dosage, or discontinue ZENBEXUS, as necessary. Initiate granulocyte colony-stimulating factor (GCSF) as appropriate per guidelines. Infections ZENBEXUS can cause serious infections, including life-threatening or fatal infections. Patients with active or uncontrolled infection should not start ZENBEXUS treatment until the infection is controlled. In the EXCALIBER-RRMM study, infections, including opportunistic infections, were reported in 78.9%, Grade 3 in 35.8%, Grade 4 in 3.4%, and fatal infections in 2% of patients receiving IberDd. Serious infections occurred in 40% of patients. Discontinuations due to infections occurred in 1.5% of patients. Monitor patients for signs and symptoms of infection prior to and during treatment with ZENBEXUS and treat appropriately. Withhold or reduce the dose based on severity. Consider prophylactic anti-infective medications according to current practice guidelines. Second Primary Malignancies In the EXCALIBER-RRMM study, at a median follow-up time of 16 months, second primary malignancies (SPM) occurred in 6.9% of patients in the IberDd arm and 4.9% of patients in the daratumumab and hyaluronidase-fihj, bortezomib, and dexamethasone (DVd) arm. Monitor patients for the development of SPM. ADVERSE REACTIONS Serious adverse reactions occurred in 58.3% of patients receiving ZENBEXUS. Serious adverse reactions in ≥2% of patients included pneumonia (26%), upper respiratory tract infection (6.4%), SPM (5.9%), neutropenia (4.9%), febrile neutropenia (3.9%), COVID-19 (4.4%), and sepsis (2.9%). Fatal adverse reactions occurred in 10 patients (4.9%) who received ZENBEXUS. Sepsis (1.5%) was the only fatal drug reaction that occurred in more than 1 patient. The following fatal adverse reactions occurred in 1 patient each: listeria encephalitis, influenza, lung adenocarcinoma, cardiac arrest, large intestine perforation, metabolic acidosis, and respiratory failure. The most common adverse reactions (≥20%) in the IberDd arm and DVd arm, respectively, were upper respiratory tract infection (54% and 52%), fatigue (36% and 33%), musculoskeletal pain (35% and 33%), pneumonia (34% and 17%), diarrhea (33% and 36%), motor dysfunction (26% and 17%), rash (26% and 15%), sleep disorder (25% and 28%), hypogammaglobulinemia (24% and 12%), COVID-19 (23% and 16%), and constipation (20% and 22%). The most common Grade 3 to 4 laboratory abnormalities (≥30%) in the IberDd arm and DVd arm, respectively, were neutropenia (77% and 11%), leukopenia (69% and 18%), and lymphopenia (62% and 51%). DRUG INTERACTIONS Effects of Other Drugs on ZENBEXUS Strong or Moderate CYP3A Inhibitors: Coadministration of ZENBEXUS with strong or moderate CYP3A inhibitors should be avoided. If a strong or moderate CYP3A inhibitor must be used in combination with ZENBEXUS, reduce the ZENBEXUS dose. Concomitant use with strong or moderate CYP3A inhibitors may increase the risk of adverse reactions. Strong or Moderate CYP3A Inducers: Coadministration of ZENBEXUS with strong or moderate CYP3A inducers should be avoided. Concomitant use with a strong or moderate CYP3A inducer may decrease the efficacy of ZENBEXUS. SPECIFIC POPULATIONS Pregnancy (See the BOXED WARNINGS) There is a pregnancy exposure registry that monitors outcomes in patients exposed to ZENBEXUS during pregnancy. See the ZENBEXUS REMS WARNINGS AND PRECAUTIONS section. Lactation Advise women not to breastfeed during treatment with ZENBEXUS. Refer to the Prescribing Information for daratumumab hyaluronidase-fihj or dexamethasone for additional information. Females and Males of Reproductive Potential ZENBEXUS can cause fetal harm when administered during pregnancy. Pregnancy Testing, Females of Reproductive Potential, and Males: See the Embryo-Fetal Toxicity WARNINGS AND PRECAUTIONS section. Geriatric Use In patients treated with IberDd, the incidence of serious adverse reactions was 53%, 56%, and 74% in adult patients younger than 65 years of age, 65 years of age to younger than 75 years of age, and 75 years of age and older, respectively. Renal Impairment Reduce the ZENBEXUS dose in patients with estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 not on dialysis. If dose modification is needed due to adverse events, reduce the ZENBEXUS dose to 1 mg every other day on Days 1 to 21 of a 28-day cycle. Please see full Prescribing Information for ZENBEXUS including Boxed WARNINGS. About Targeted Protein Degradation and CELMoD Targeted protein degradation (TPD) is a differentiated research platform at Bristol Myers Squibb built on more than two decades of scientific expertise, providing new avenues to degrade therapeutically relevant proteins that were previously considered difficult to address. BMS is the only company that has successfully developed and commercialized protein degrader agents for the treatment of multiple myeloma. These agents, known as immunomodulatory drugs (IMiDs), helped establish the current standard of care in the treatment of this disease, which remains without a cure. BMS is building on this foundation with several investigational protein degraders in clinical trials, leveraging three different modalities including cereblon E3 ligase modulators (CELMoDs), ligand-directed degraders (LDDs), and degrader antibody conjugates (DACs). This three-pronged approach enables matching the right therapeutic modality to a molecular mechanism of action to modulate targets most effectively and ultimately provides more opportunities for potential breakthroughs that may offer meaningful new options for patients across a broad range of diseases, in and beyond hematology and oncology. Learn more about the science behind TPD at Bristol Myers Squibb here . About Ongoing Trials Zenbexus ™ is also being evaluated in the EXCALIBER Maintenance study. About Bristol Myers Squibb: Transforming Patients’ Lives Through Science At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com or follow us on LinkedIn , X , YouTube , Facebook and Instagram . Cautionary Statement Regarding Forward-Looking Statements 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. 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. These risks, assumptions, uncertainties and other factors include, among others, that results of future post-marketing studies will be consistent with the results of this study, that ZENBEXUS TM (iberdomide) in combination with daratumumab and dexamethasone (ZDd) for the indication described in this release may not be commercially successful, any marketing approvals, if granted, may have significant limitations on their use, and, that continued approval of ZENBEXUS TM for such indication may be contingent upon verification and description of clinical benefit in additional confirmatory trials. 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, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news Contacts Bristol Myers Squibb M edia Inquiries: media@bms.com Investors: investor.relations@bms.com

创新药审批持续提速，2026 年第三季度，中美药监机构接连批准多款全新治疗药物，覆盖抗肿瘤、神经精神、血液疾病、自身免疫、抗感染、内分泌代谢及罕见病等多个赛道，为恶性肿瘤、自身免疫性疾病、神经系统疑难病症提供了新的临床干预方案。 中国国家药品监督管理局（NMPA）：2026 年第三季度，NMPA 批准多款一类创新药，同时多款中药创新制剂获批，覆盖阿尔茨海默病、发作性睡病、抑郁症、肺癌、胆管癌、多发性骨髓瘤、阵发性睡眠性血红蛋白尿症、银屑病、痛风、新冠感染、RSV 预防、糖尿病等适应症，代表性药物如下： 中西药持续聚集催眠、抑郁药 奥普雷顿片（奥泽悦） 获批时间：2026 年 7 月 23 日 适应症：用于 16 岁及以上青少年与成人 1 型发作性睡病。 亮点：中国首个获批的口服高选择性食欲素2型受体（OX2R）激动剂，也是目前唯一获批用于治疗1型发作性睡病的创新药物‌，实现了从“对症治疗”到“对因治疗”的突破。 醒脾解郁片 获批时间：2026 年 9 月 3 日 适应症：用于湿浊困脾、气机郁滞证的轻中度抑郁症，改善情绪低落、睡眠异常、脾胃失调等身心表现。 亮点：1.1类中药创新药，填补了中医情志病精准治疗的创新空白。 肿瘤靶向治疗新突破 甲磺酸氘申艾替尼片（卡达沙） 获批时间：2026 年 8 月 31 日 适应症：EGFR19 外显子缺失或 L858R 突变、合并中枢转移的局部晚期 / 转移性非小细胞肺癌成人一线治疗。 亮点：是国内首款针对EGFR突变非小细胞肺癌脑转移一线治疗的国产1类创新药，专攻肺癌脑转移，颅内疗效数据显著优于现有标准疗法‌。 替恩戈替尼片（捷恩泰） 获批时间：2026 年 8 月 11 日 适应症：既往经过系统治疗及 FGFR 抑制剂用药，携带 FGFR2 融合 / 重排的晚期胆管癌成人患者。 亮点：‌全球首个获批专门针对FGFR抑制剂经治耐药胆管癌的药物‌，填补了这一领域的治疗空白。 注射用菲泽妥单抗（境斐） 获批时间：2026 年 8 月 13 日 适应症：联合来那度胺、地塞米松，用于至少接受过一线方案的多发性骨髓瘤成人患者。 亮点：精准靶向CD38、清除致病浆细胞，同时输注时间短、不良反应更少‌，并且是这款药在全球的首次获批上市。 纬利妥米单抗注射液（维可妥） 获批时间：2026 年 8 月 31 日 适应症：经蛋白酶体抑制剂、免疫调节剂、抗 CD38 单抗等至少三线治疗失败的复发难治多发性骨髓瘤成人。 亮点：国产首个获批上市的BCMA/CD3双特异性抗体‌，打破了该赛道进口产品垄断的局面，为国内患者提供了新的治疗选择。‌‌ 酒石酸凡瑞格拉替尼片（爱领达） 获批时间：2026 年 8 月 31 日 适应症：既往接受系统治疗、携带 FGFR2 融合或重排的不可切除肝内胆管癌成人患者。 亮点：中国首个自主研发的高选择性FGFR1/2/3抑制剂，用于治疗携带FGFR2融合或重排的晚期肝内胆管癌‌。 银屑病患者获得新希望 瑞西奇拜单抗注射液（华亦净） 获批时间：2026 年 7 月 29 日 适应症：体重≥40kg 成人泛发性脓疱型银屑病急性发作。 亮点：国内首个自主研发获批的靶向IL-36R人源化单克隆抗体‌，用于治疗成人（体重≥40kg）泛发性脓疱型银屑病（GPP）发作，填补了国产药物在这一罕见病领域的空白。 莱康奇塔单抗注射液（丽倍坦） 获批时间：2026 年 8 月 31 日 适应症：适合系统或光疗干预的中重度斑块状银屑病成人。 亮点：是‌中国首个自主研发的IL-17A/F双靶点抑制剂‌，能更全面地阻断炎症通路，且在临床试验中疗效优于现有标杆药物司库奇尤单抗。       以上便是 2026Q3 中美新药速递上篇，盘点了 NMPA 三季度集中获批的多款一类创新药与中药创新制剂，众多难治疾病迎来全新治疗方案。       大洋彼岸美国 FDA 本季度也迎来多款重磅新药获批，创新靶点与临床数据同样值得关注。下篇带来 FDA 新药详细解读，持续追踪全球新药前沿，不要错过。 关于玄合医疗 玄合医疗于2019年8月8日在上海浦东张江国际医学园区成立。由国内著名医学专家丁罡教授创建，秉承“仁爱、诚信、创新、追求卓越、社会责任感”的价值观，致力于科技创新、管理变革、服务升级，整合国际先进生物医药技术、医疗管理、互联网技术、患者教育等资源，开展多学科一体化精准综合治疗和学科建设与管理。同时创建国内患者教育中心，提供中国居民的主动健康教育。 集团的肿瘤中心是目前国内最早和最大规模专注难治性肿瘤多学科综合诊治。团队开展包含肿瘤的影像、病理、手术、放疗、内科、微创介入、重症、心理、中医药、康复护理、营养和临床试验等专科医疗服务。主要服务机构上海国际医学中心肿瘤中心，建立国内肿瘤一站式全程全周期个性化服务，获得国家药监局批准的上海地区社会办医最早开展肿瘤药物临床试验单位，创建中国高品质肿瘤服务创新平台，成为中国非公立医疗机构肿瘤医协体中心，中国抗癌协会临床培训、康复上海基地。 集团的健管中心是中国第一家研究型综合门诊部。秉持着“主动预防，科技引领，健康生活”的理念，致力于将最先进的科技应用于健康领域，特别在社区与家庭主动健康管理领域，开启数智健康科技发展和创新。帮助人们实现更健康、更长寿、更高质量的生活，让健康触手可及。 主动健康创新业务范围包括： 1. 智能穿戴设备：开发和生产具有实时监测、数据分析功能的智能手环、智能手表等穿戴设备，帮助用户实时了解身体状况，预防疾病。 2. 健康管理平台：提供个性化的健康管理方案，包括营养饮食、运动健身、心理健康等方面的建议和指导，帮助用户建立健康的生活方式。 3. 远程医疗服务：利用互联网和移动医疗技术，为用户提供线上问诊、药品配送、健康咨询等一站式服务，方便用户随时随地获取医疗服务。 4. 社区队列研究：针对浦东周浦镇社区慢病人群，开展队列研究。整合医学院校、医疗机构、生物医药企业、政府机构等资源，开展社区慢病健康管理，健康教育，流行病研究，预防干预。建立样本库，数据库，细胞库和基因库等生物医药科研平台。 玄合医疗始终坚持以技术创新为核心竞争力，不断投入研发资源，推动健康科技的创新发展。企业拥有多项国内外专利，其技术成果在行业内具有广泛的影响力。2024年5月18日与美国马里兰州蒙特马利郡合作，共建国际生物医药转化中心。建立上海市浦东新区东方肿瘤神经科学研究院和上海市浦东新区东方智慧康养研究院。 玄合医疗积极履行社会责任，致力于提高公众健康意识和水平。定期举办健康科普讲座、公益活动，普及健康知识，帮助更多人建立健康的生活方式。同时，企业还关注弱势群体的健康问题，为他们提供力所能及的帮助和支持。玄合医疗是上海市浦东新区癌症康复促进会的会长单位。上海市癌症康复俱乐部的医疗服务副会长单位。 未来，玄合医疗将继续秉承“主动预防，科技引领，健康生活”的理念，不断创新和发展健康科技，为人们提供更加便捷、高效、个性化的健康服务。企业还将积极拓展国际市场，与全球合作伙伴共同推动健康科技的全球发展，为人类健康事业贡献中国方案与智慧。 供稿：黄   艳 编辑：崔加奇 审核：诸颖莹