Mylotarg (gemtuzumab ozogamicin): Market Withdrawal Audience: Oncology, Hematology [Posted 06/21/2010] ISSUE: FDA notified healthcare professionals that 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. BACKGROUND: Mylotarg (gemtuzumab ozogamicin), indicated for treatment of acute myeloid leukemia (AML), a bone marrow cancer, was approved in May 2000 under the FDA’s accelerated approval program. 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. RECOMMENDATION: 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. Any future use of Mylotarg in the United States will require submission of an investigational new drug application to the FDA. [06/21/2010 - News Release - FDA] Ref: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm216458.htm 缩：http://0rz.tw/kMrI2 　　Pfizer进行的post-approval clinical trial在实验初期即因临床效果不好而 终止，并发现在接受Gemtuzumab的族群死亡率较接受单一化疗的受试者还高。 故FDA将Gemtuzumab下市。 　　* 新发病的病人：不建议使用Gemtuzumab * 正在用Gemtuzumab的病人：可能可以继续完成疗程，并请谘询专业医疗人员。 　　* 医事人员：需知会正在使用Gemtuzumab的病人此药的安全性疑虑。 　 --------- 每天看湖人版有好多外电 希望 药师/药学版 也可以有很多外电资讯 ^^ --------- -- ┌ 暗恋--->时间久---->痛苦--->结束 朋友---->喜欢─┤ ┌ 失败--->避不见面--->痛苦-->结束 (常在一起) └ 表白 ┤ ┌ 恋爱-->日久无趣-->痛苦-->结束 (挣扎) └ 成功 ├ 恋爱-->移情别恋-->痛苦-->结束 └ 恋爱-->结婚-->更大的痛苦-->无法结束 --

※ 发信站: 批踢踢实业坊(ptt.cc) ◆ From: 118.170.193.88 ※ 编辑: pharmawind 来自: 118.170.193.88 (06/24 00:54)