FDA approves Sarclisa® for patients with relapsed refractory multiple myeloma

FDA 批准 Sarclisa ®用于复发难治多发性骨髓瘤患者

2020-03-03 05:00:35 CISION

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The U.S. Food and Drug Administration has approved Sarclisa® in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is expected to be available to patients in the U.S. shortly. Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. "Today's FDA approval of Sarclisa provides a new treatment option for patients with difficult-to-treat multiple myeloma. These are patients whose disease has returned or become resistant to their prior treatments," said Paul Hudson, Chief Executive Officer, Sanofi. "At Sanofi, we are focused on discovering and developing medicines that may change the practice of medicine, and Sarclisa offers a potential new standard of care in the United States. We continue to evaluate Sarclisa in a comprehensive clinical program in multiple myeloma, as well as in other blood cancers and solid tumors." Sarclisa Safety Profile and Efficacy in Difficult-to-Treat Patients In the ICARIA-MM study, Sarclisa added to pom-dex (Sarclisa combination therapy) demonstrated a statistically significant improvement in progression free survival (PFS) with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone (HR 0.596, 95% CI: 0.44-0.81, p=0.0010). Sarclisa combination therapy also demonstrated a significantly greater overall response rate compared to pom-dex alone (60.4% vs. 35.3%, p<0.0001).   "Most patients with multiple myeloma unfortunately relapse and become refractory to currently available therapies. Sarclisa used in combination with pomalidomide and dexamethasone offers an important new treatment option for patients in the United States living with this incurable disease," said Paul Richardson, MD, principal investigator of ICARIA-MM, and clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute. "The pivotal ICARIA-MM trial was the first Phase 3 study of a CD38 antibody in combination with pom-dex to present results demonstrating significant clinical benefit in this setting. The study enrolled a broad population of patients with relapsed and refractory multiple myeloma that is particularly difficult to treat and with poor prognosis, which is reflective of real-world practice." The most common adverse reactions (occurring in 20% or more of patients) in patients who received Sarclisa combination therapy were neutropenia (96%), infusion-related reactions (39%), pneumonia (31%), upper respiratory tract infection (57%) and diarrhea (26%). Serious adverse reactions that occurred in more than 5% of patients who received Sarclisa combination therapy included pneumonia (25.3%) and febrile neutropenia (12.3%). Permanent discontinuation of Sarclisa combination therapy due to an adverse reaction (Grades 3-4) occurred in 7% of patients, and 3% of patients discontinued due to an infusion-related reaction. An Important New Option for Treating Multiple Myeloma Sarclisa offers an intravenous (IV) administration and is dosed at 10 mg/kg, in combination with pom-dex, every week for four weeks and then every two weeks, until disease progression or unacceptable toxicity. The first cycle is administered in an infusion time of 200 minutes, which can decrease to 75 minutes for the third cycle onwards. A treatment cycle is 28 days. The U.S. list price (wholesale acquisition cost, or WAC) for Sarclisa is $650 per 100 mg vial and $3,250 per 500 mg vial. For a typical patient in the U.S., between 70-80 kg (154-176 lbs), this correlates to a cost of $5,200 per infusion. Actual costs to patients are generally anticipated to be lower as the list price does not reflect insurance coverage, copay support, or financial assistance from patient support programs. Sanofi is committed to responsible pricing while bringing innovative and valuable therapies to patients with significant unmet need. Patients in the U.S. who have been prescribed Sarclisa may be eligible to enroll in the CareASSIST Patient Support Program, which provides reimbursement support and financial assistance to eligible patients. For more information, please call 1-833-WE+CARE (1-833-930-2273) or visit SanofiCareAssist.com/Sarclisa. Multiple Myeloma Leads to Significant Disease Burden Multiple myeloma is the second most common hematologic malignancy,i affecting more than 130,000 patients in the United States; approximately 32,000 Americansii are diagnosed with multiple myeloma each year. Despite available treatments, multiple myeloma remains an incurable malignancy, and is associated with significant patient burden. As patients relapse, they can become refractory to therapies they have received. There is a need for new agents so that patients and physicians can have options as the disease progresses over time. Relapsed (or recurrent) multiple myeloma means that the cancer returns after treatment or a period of remission. Since multiple myeloma does not have a cure, most patients will relapse at some point. Refractory multiple myeloma refers to cancer that does not respond to therapy. About Sarclisa Sarclisa is a monoclonal antibody (mAb) that binds to the CD38 receptor on multiple myeloma cells. It is designed to induce programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on multiple myeloma cells and cell surface receptors, making it a potential target for antibody-based therapeutics such as Sarclisa. Sarclisa has Orphan Drug Designation status from the FDA and the European Medicines Agency (EMA). In the second quarter of 2019, the EMA accepted for review the Marketing Authorization Application for use of Sarclisa in combination with pom-dex for the treatment of certain patients with RRMM. The safety and efficacy of Sarclisa has not been fully evaluated by any regulatory authority outside of the U.S. Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments for people with relapsed refractory or newly diagnosed multiple myeloma. It is also under investigation for the treatment of other blood cancer types (hematologic malignancies) and solid tumors. IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS What is SARCLISA? SARCLISA is a prescription medicine used in combination with pomalidomide and dexamethasone to treat adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor, to treat multiple myeloma. It is not known if SARCLISA is safe and effective in children. Do not receive SARCLISA if you have a history of severe allergic reaction to isatuximab-irfc or any of the ingredients in SARCLISA (see the list of ingredients in full Prescribing Information). Before receiving SARCLISA, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment with SARCLISA. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive SARCLISA? Your healthcare provider will decide how long you should receive SARCLISA. What are the possible side effects of SARCLISA? SARCLISA may cause serious side effects, including: Tell your healthcare provider right away if you develop any of the following symptoms of infusion reaction during or within 24 hours after an infusion of SARCLISA:  Your healthcare provider will check your blood cell counts during treatment with SARCLISA. Your healthcare provider may prescribe an antibiotic or antiviral medicine to help prevent infection, or a medicine to help increase your white blood cell counts during treatment with SARCLISA. Tell your healthcare provider right away if you develop any fever or symptoms of infection during treatment with SARCLISA. The most common side effects of SARCLISA include: These are not all the possible side effects of SARCLISA. For more information, ask your healthcare provider or pharmacist. Please see full Prescribing Information, including Patient Information. About Sanofi Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi, Empowering Life Media Relations ContactAshleigh KossTel.: +1 908-981-8745[email protected] Investor Relations ContactFelix Lauscher Tel.: +33 (0)1 53 77 45 45[email protected] Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the absence of guarantee that the product will be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2018. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. i Kazandjian. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676-681. doi:10.1053/j/seminoncol.2016.11.004ii  National Cancer Institute. Myeloma Cancer Stat Facts. Available at: www.seer.cancer.gov/statfacts/html/mulmy.html. Accessed on December 12, 2019. Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY) SOURCE Sanofi Related Links http://www.sanofi.us
美国食品药品监督管理局(Food and Drug Administration)已经批准了 Sarclisa ®与 Pomalidide 和地塞米松联合用于治疗复发的难治多发性骨髓瘤成人,他们已经接受至少两种先前的治疗,包括来那度胺和蛋白酶体抑制剂。预计 Sarclisa 不久将在美国上市。 Sarclisa 是一种单克隆抗体,与多发性骨髓瘤细胞 CD38受体结合。 “今天 FDA 批准 Sarclisa 为难以治疗的多发性骨髓瘤患者提供了一种新的治疗选择。这些患者的疾病已经恢复或成为抵抗他们以前的治疗,”保罗哈德森说,首席执行官,赛诺菲(Sanofi)。“在赛诺菲(Sanofi),我们专注于发现和开发可能改变医学实践的药物,而 Sarclisa 在美国提供了一个潜在的新的护理标准。我们继续在多发性骨髓瘤以及其他血液肿瘤和实体肿瘤的综合临床项目中评估 Sarclisa 。” Sarclisa 在难治患者中的安全性和有效性 在 ICARIA-MM 研究中, Sarclisa 加入了 pom-dex ( Sarclisa 组合疗法)后,无进展生存期( PFS )有统计学意义的改善,其中 PFS 为11.53个月,而仅 pom-dex 为6.47个月( HR 0.596,95% CI :0.44-0.81, p =0.0010)。Sarclisa 联合治疗与单纯的 pom-dex 相比,总体反应率显著提高(60.4% vs.35.3%, p <0.0001)。 “大多数多发性骨髓瘤患者不幸复发,并变得难以接受目前可用的治疗。Sarclisa 与 Pomaldomide 和地塞米松联合使用,为美国患有这种不治之症的患者提供了一个重要的新治疗选择。Dana-Farber 癌症研究所 Jerome Lipper 多发性骨髓瘤中心临床研究项目负责人和主任。“关键的 ICARIA-MM 试验是 CD38抗体与 Pom-dex 联合进行的第一个第3阶段研究,其结果表明在此背景下具有显著的临床益处。这项研究招募了大量复发和难治性多发性骨髓瘤患者,这些患者特别难以治疗,预后差,这反映了现实世界的实践。 接受 Sarclisa 联合治疗的患者中最常见的不良反应(20%或以上患者)为中性粒细胞减少(96%)、输液相关反应(39%)、肺炎(31%)、上呼吸道感染(57%)和腹泻(26%)。5%以上接受 Sarclisa 联合治疗的患者出现严重不良反应,包括肺炎(25.3%)和发热中性粒细胞减少(12.3%)。7%的患者因不良反应(3-4级)而永久停止 Sarclisa 联合治疗,3%的患者因输液相关反应而停止治疗。 治疗多发性骨髓瘤的新方法 Sarclisa 提供静脉( IV )给药,每周给药10毫克/千克,与 pom-dex 联合给药4周,然后每两周给药,直到疾病进展或不可接受的毒性。第一个周期的输注时间为200分钟,第三个周期的输注时间可减少到75分钟。治疗周期为28天。 Sarclisa 的美国定价(批发收购成本,简称 WAC )为每100毫克瓶650美元,每500毫克瓶3250美元。对于一个典型的美国患者,70-80公斤(154-176磅)之间,这与每次输液的费用5,200美元有关。患者的实际成本通常被认为是较低的,因为标价并不反映保险范围、共同自付费费用或患者支持计划的财政援助。赛诺菲(Sanofi)致力于负责任的定价,同时为未满足重大需求的患者提供创新和有价值的治疗。 在美国,处方 Sarclisa 的患者可能有资格参加 CareASSIST 患者支持计划,该计划为符合条件的患者提供报销支持和财政援助。如需更多信息,请致电1-833-WE + CARE (1-833-930-2273)或访问 SanofCareAssistant 。com / Sarclisa 。 多发性骨髓瘤导致重大疾病负担 多发性骨髓瘤是第二大最常见的血液恶性肿瘤,我影响了130,000多名美国病人;每年大约有32,000名美国人被诊断为多发性骨髓瘤。尽管有可用的治疗方法,多发性骨髓瘤仍然是不可治愈的恶性肿瘤,并与重大的病人负担。随着患者复发,他们可能变得难以接受治疗。需要新的药物,使病人和医生可以选择随着疾病的进展。复发(或复发)多发性骨髓瘤是指治疗后或缓解期后肿瘤复发。由于多发性骨髓瘤没有治愈方法,大多数患者会在某个时候复发。难治性多发性骨髓瘤是指对治疗无效的癌症。 关于 Sarclisa Sarclisa 是一种单克隆抗体( mAb ),与多发性骨髓瘤细胞 CD38受体结合。其目的是诱导程序性肿瘤细胞死亡(细胞凋亡)和免疫调节活性。CD38在多发性骨髓瘤细胞和细胞表面受体上高度一致地表达,使其成为 Sarclisa 等抗体疗法的潜在靶标。 Sarclisa 拥有来自 FDA 和欧洲药品管理局( EMA )的孤儿药物指定地位。2019年第二季度, EMA 受理了《 Sarclisa 与 pom-dex 联合用于治疗某些 RRMM 患者的上市许可申请》。Sarclisa 的安全性和有效性尚未得到美国以外任何监管机构的充分评估。 Sarclisa 将继续在多个正在进行的3期临床试验中进行评估,并结合目前对复发难治性或新诊断的多发性骨髓瘤患者的标准治疗。它也正在研究治疗其他血癌类型(血液肿瘤)和实体肿瘤。 美国旅客的重要安全资料及标记 什么是 SARCLISA ? SARCLISA 是一种处方药,与泊马林多和地塞米松联合使用,用于治疗已接受至少2种先前治疗的成年人,包括来那度胺和蛋白酶体抑制剂,以治疗多发性骨髓瘤。 目前尚不清楚 SARCLISA 是否对儿童安全有效。 如果您有过严重过敏反应的历史,不接受 SARCLISA 或 SARCLISA 中的任何成分(请参阅全部压力信息中的成分列表)。 在收到 SARCLISA 之前,向您的医疗保健提供者告知您的所有医疗状况,包括: 如果你认为你怀孕或在 SARCLISA 治疗期间怀孕,马上告诉你的医疗保健提供者。 告诉你的保健提供者你服用的所有药物,包括处方和非处方药,维生素和草药补充剂。 我将如何收到 SARCLISA ? 您的医疗保健提供者将决定您应该接收 SARCLISA 的时间。 SARCLISA 的可能副作用是什么? SARCLISA 可能导致严重的副作用,包括: 如果您在注射 SARCLISA 期间或之后24小时内出现以下任何输液反应症状,请立即告知您的医疗保健提供者: 您的医疗保健提供者将检查您的血液细胞计数治疗与 SARCLISA 。您的医疗保健提供者可能会开一种抗生素或抗病毒药物,以帮助防止感染,或一种药物,以帮助增加您的白血球计数在治疗过程中与 SARCLISA 。 如果在 SARCLISA 治疗期间出现发烧或感染症状,请立即告知您的医疗保健提供者。 SARCLISA 最常见的副作用包括: 这些并不是 SARCLISA 的所有可能的副作用。有关更多信息,请咨询您的医疗保健提供者或药剂师。 请参阅完整的处方信息,包括患者信息。 关于赛诺菲(Sanofi) 赛诺菲(Sanofi)致力于通过健康挑战来支持人们。我们是一家致力于人类健康的全球生物制药公司。我们用疫苗预防疾病,提供创新的治疗方法来对抗疼痛和减轻痛苦。我们站在少数几个患有罕见疾病和数百万长期慢性病的人面前。 赛诺菲(Sanofi)在全球100多个国家拥有超过10万名员工,正在将科学创新转化为医疗解决方案。 赛诺菲(Sanofi),赋予生命权力 媒体关系联系人 Ashleigh KossTel 。:+1908-981-8745[受电子邮件保护] 投资者关系联系人 Felix Lauscher 电话.:+33(0)1537745[受电子邮件保护] 赛诺菲(Sanofi)前瞻性陈述本新闻稿包含前瞻性陈述,定义见1995年《私人证券诉讼改革法案》修订。前瞻性陈述是不属于历史事实的陈述。这些报表包括关于产品营销和其他潜力的预测和估计,或关于产品的潜在未来收入。前瞻性陈述通常用“预期”、“预期”、“相信”、“意向”、“估计”、“计划”和类似表述来标识。尽管赛诺菲管理层认为该等前瞻性陈述所反映的预期是合理的,但提请投资者注意,前瞻性信息和陈述存在各种风险和不确定性,其中许多风险和不确定性难以预测,且一般超出赛诺菲(Sanofi)的控制范围。这可能导致实际结果和事态发展与前瞻性信息和声明所表达或暗示或预测的结果和事态发展存在重大差异。这些风险和不确定性包括,意外的监管行动或延迟,或一般的政府监管,可能影响产品的可用性或商业潜力,没有保证产品将在商业上成功,研究和开发固有的不确定性,包括与产品相关的现有临床数据的未来临床数据和分析,包括上市后、意外安全、质量或制造问题、一般竞争、与知识产权和任何相关未来诉讼相关的风险以及此类诉讼的最终结果,以及不稳定的经济状况;以及赛诺菲(Sanofi)向 SEC 和 AMF 提交的公开文件中讨论或识别的风险,包括在赛诺菲截止2018年12月31日的20-F 年度报告中“风险因素”和“关于前瞻性陈述的谨慎声明”中列出的风险。除适用法律要求外,赛诺菲(Sanofi)不承担任何更新或修改任何前瞻性信息或声明的义务。 i Kazandjian 。多发性骨髓瘤流行病学与生存:一种独特的恶性肿瘤。Semin Oncol 。2016年;43(6):676-681。doi :10.1053/ j / seminopal 。2016.11.004ii 国家癌症研究所。米洛玛癌症统计资料.网址: www.seor.cancer.gov / statfacts / html / mulmy 。html 。于2019年12月12日进场。 来源:赛诺菲(Sanofi)( EURONEEXT : SAN )(纳斯达克: SNY ) SOURCE 赛诺菲(Sanofi) 相关链接 http://www.sanofi.us

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