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【drug-news】FDA：辉瑞主动在美国市场撤回麦罗塔

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辉瑞麦罗塔Mylotarg (gemtuzumab ozogamicin) 主要用于治疗急性髓系白血病，日期辉瑞主动在美国市场撤回该药。

fizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

Mylotarg was approved in May 2000 under the FDA’s accelerated approval program. This program allows the agency to approve a drug to treat serious diseases with an unmet medical need based on a surrogate endpoint – a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that directly measures how a patient feels, functions, or survives.

Under accelerated approval, the company is required to conduct additional clinical trials after approval to confirm the drug’s benefit. If those trials fail to confirm clinical benefit to patients, or if the company does not pursue the required confirmatory trials with due diligence, the FDA can withdraw the drug from the market using expedited procedures.

Mylotarg was approved to treat patients ages 60 years and older with recurrent AML who were not considered candidates for other chemotherapy. The initial approval was based on the surrogate endpoint of response rate (i.e., the percentage of patients whose leukemia decreased or disappeared in laboratory tests), observed in 142 patients with AML across three clinical trials.

A confirmatory, post approval clinical trial was begun by Wyeth (now Pfizer) in 2004. The trial was designed to determine whether adding Mylotarg to standard chemotherapy demonstrated an improvement in clinical benefit (survival time) to AML patients. The trial was stopped early when no improvement in clinical benefit was observed, and after a greater number of deaths occurred in the group of patients who received Mylotarg compared with those receiving chemotherapy alone.

At initial approval, Mylotarg was associated with a serious liver condition called veno-occlusive disease, which can be fatal. This rate has increased in the postmarket setting.

“Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products, part of FDA’s Center for Drug Evaluation and Research. “However, a confirmatory clinical trial and years of postmarketing experience with the product have not shown evidence of clinical benefit in patients with AML.”

As a result of the withdrawal, Mylotarg will not be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy following consultation with their health care professional. Health care professionals should inform all patients receiving Mylotarg of the product’s potential safety risks.

Following the withdrawal, any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA.

Mylotarg is manufactured by New York City-based Pfizer.

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2010-06-22 09:37 浏览 : 1608 回复 : 3

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认领本文翻译，若48小时内未完成，请其他战友继续。

2010-06-22 09:44

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初译：

（June 21, 2010）Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.
2010年6月21日，辉瑞公司（Pfizer Inc.）宣布自动将用于治疗一种名为急性骨髓性白血病（AML）的骨髓癌药物麦罗塔（Mylotarg，通用名为gemtuzumab ozogamicin吉妥单抗）从美国市场上撤出。该公司采取上述行动是在美国食品药品监督管理局（FDA）的要求下而进行的，因为一项最新的临床试验引发了有关该药安全性的新问题，并且麦罗塔亦未能证明对纳入相关试验的患者有临床疗效。
Mylotarg was approved in May 2000 under the FDA’s accelerated approval program. This program allows the agency to approve a drug to treat serious diseases with an unmet medical need based on a surrogate endpoint – a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that directly measures how a patient feels, functions, or survives.
麦罗塔是于2000年5月通过FDA的快速审批程序（accelerated approval program）而获准上市的。该程序允许FDA根据替代终点（surrogate endpoint）来批准用于治疗当前医学无法满足的严重疾病的药物，所谓替代终点是一种用于代替直接检查患者感受、功能恢复或存活情况的临床终点的实验室研究或身体体征。
Under accelerated approval, the company is required to conduct additional clinical trials after approval to confirm the drug’s benefit. If those trials fail to confirm clinical benefit to patients, or if the company does not pursue the required confirmatory trials with due diligence, the FDA can withdraw the drug from the market using expedited procedures.
在快速审批的过程中，FDA要求辉瑞在药物被批准后进行附加的临床试验以证实麦罗塔的疗效。如果这些试验无法证实该药对患者有临床疗效，或该公司未认真进行FDA所要求的证实性试验，则FDA会撤消该药通过快速审批程序所获得的上市许可。
Mylotarg was approved to treat patients ages 60 years and older with recurrent AML who were not considered candidates for other chemotherapy. The initial approval was based on the surrogate endpoint of response rate (i.e., the percentage of patients whose leukemia decreased or disappeared in laboratory tests), observed in 142 patients with AML across three clinical trials.
麦罗塔已被批准用于治疗60岁及以上伴有复发性AML且不考虑接受其他化疗的患者。该药的最初获批是基于在3项临床试验中的142名AML患者中所观察到的反应比率的替代终点（如在实验室检验中显示白血病减少或消失的患者百分比）。
A confirmatory, post approval clinical trial was begun by Wyeth (now Pfizer) in 2004. The trial was designed to determine whether adding Mylotarg to standard chemotherapy demonstrated an improvement in clinical benefit (survival time) to AML patients. The trial was stopped early when no improvement in clinical benefit was observed, and after a greater number of deaths occurred in the group of patients who received Mylotarg compared with those receiving chemotherapy alone.
由惠氏公司（现已被辉瑞收购）进行的一项证实性、批准后临床试验始于2004年。该试验的目的是用于确定在常规化疗中加用麦罗塔是否真的对AML患者在临床疗效（存活时间）上有提高。当观察到该药在临床疗效方面并无改善，并且在接受麦罗塔治疗的患者组的死亡人数大于接受单独化疗患者组时，这项试验很早就被停止了。
At initial approval, Mylotarg was associated with a serious liver condition called veno-occlusive disease, which can be fatal. This rate has increased in the postmarket setting.
在最初被批准使用时，麦罗塔就已与一种名为静脉闭塞性疾病（veno-occlusive disease）的致命性严重肝病有关联，并且这种疾病的发生率在该药上市后的使用过程中有增加。
“Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products, part of FDA’s Center for Drug Evaluation and Research. “However, a confirmatory clinical trial and years of postmarketing experience with the product have not shown evidence of clinical benefit in patients with AML.”
FDA药物评估和研究中心的肿瘤药品办公室主任Richard Pazdur医学博士表示，“麦罗塔是通过一种快速审批程序而获得上市的，这种审批程序可允许患者使用被认为对某种伤害性极大的癌症类型有治疗希望的新药物。不过，一项证实性临床试验和该药数年的上市后体验均未显示麦罗塔对AML患者有临床疗效的证据。”
As a result of the withdrawal, Mylotarg will not be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy following consultation with their health care professional. Health care professionals should inform all patients receiving Mylotarg of the product’s potential safety risks.
在这次撤市之后，麦罗塔将不在以商业的形式用于新患者。正在接受该药治疗的患者在与其医护人员沟通后可结束治疗。医护人员应告知所有接受麦罗塔治疗的患者有关该药的潜在安全风险。

Following the withdrawal, any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA.
在此次撤市之后，麦罗塔将来在美国的任何一种使用都将需要向FDA提交一项研究性新药申请。
Mylotarg is manufactured by New York City-based Pfizer.
麦罗塔由总部位于纽约市的辉瑞公司生产。

2010-06-22 15:12

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整理：

FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg from U.S. Market
FDA：辉瑞主动在美国市场撤回抗癌药麦罗塔

2010年6月21日，辉瑞公司（Pfizer Inc.）宣布自动将用于治疗一种名为急性骨髓性白血病（AML）的骨髓癌药物麦罗塔（Mylotarg，通用名为gemtuzumab ozogamicin吉妥单抗）从美国市场上撤出。该公司采取上述行动是在美国食品药品监督管理局（FDA）的要求下而进行的，因为一项最新的临床试验引发了有关该药安全性的新问题，并且麦罗塔亦未能证明对纳入相关试验的患者有临床疗效。
麦罗塔是于2000年5月通过FDA的快速审批程序（accelerated approval program）而获准上市的。该程序允许FDA根据替代终点（surrogate endpoint）来批准用于治疗当前医学无法满足的严重疾病的药物，所谓替代终点是一种用于代替直接检查患者感受、功能恢复或存活情况的临床终点的实验室研究或身体体征。
在快速审批的过程中，FDA要求辉瑞在药物被批准后进行附加的临床试验以证实麦罗塔的疗效。如果这些试验无法证实该药对患者有临床疗效，或该公司未认真进行FDA所要求的证实性试验，则FDA会撤消该药通过快速审批程序所获得的上市许可。
麦罗塔已被批准用于治疗60岁及以上伴有复发性AML且不考虑接受其他化疗的患者。该药的最初获批是基于在3项临床试验中的142名AML患者中所观察到的反应比率的替代终点（如在实验室检验中显示白血病减少或消失的患者百分比）。
由惠氏公司（现已被辉瑞收购）进行的一项证实性、批准后临床试验始于2004年。该试验的目的是用于确定在常规化疗中加用麦罗塔是否真的对AML患者在临床疗效（存活时间）上有提高。当观察到该药在临床疗效方面并无改善，并且在接受麦罗塔治疗的患者组的死亡人数大于接受单独化疗患者组时，这项试验很早就被停止了。
在最初被批准使用时，麦罗塔就已与一种名为静脉闭塞性疾病（veno-occlusive disease）的致命性严重肝病有关联，并且这种疾病的发生率在该药上市后的使用过程中有增加。
FDA药物评估和研究中心的肿瘤药品办公室主任Richard Pazdur医学博士表示，“麦罗塔是通过一种快速审批程序而获得上市的，这种审批程序可允许患者使用被认为对某种伤害性极大的癌症类型有治疗希望的新药物。不过，一项证实性临床试验和该药数年的上市后体验均未显示麦罗塔对AML患者有临床疗效的证据。”
在这次撤市之后，麦罗塔将不在以商业的形式用于新患者。正在接受该药治疗的患者在与其医护人员沟通后可结束治疗。医护人员应告知所有接受麦罗塔治疗的患者有关该药的潜在安全风险。
在此次撤市之后，麦罗塔将来在美国的任何一种使用都将需要向FDA提交一项研究性新药申请。
麦罗塔由总部位于纽约市的辉瑞公司生产。

译者提示：经查SFDA网站数据库，该药尚未在我国上市。

2010-06-22 15:14

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