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 縮：http://0rz.tw/kMrI2 　　Pfizer進行的post-approval clinical trial在實驗初期即因臨床效果不好而 終止，並發現在接受Gemtuzumab的族群死亡率較接受單一化療的受試者還高。 故FDA將Gemtuzumab下市。 　　* 新發病的病人：不建議使用Gemtuzumab * 正在用Gemtuzumab的病人：可能可以繼續完成療程，並請諮詢專業醫療人員。 　　* 醫事人員：需知會正在使用Gemtuzumab的病人此藥的安全性疑慮。 　 --------- 每天看湖人版有好多外電 希望 藥師/藥學版 也可以有很多外電資訊 ^^ --------- -- ┌ 暗戀--->時間久---->痛苦--->結束 朋友---->喜歡─┤ ┌ 失敗--->避不見面--->痛苦-->結束 (常在一起) └ 表白 ┤ ┌ 戀愛-->日久無趣-->痛苦-->結束 (掙扎) └ 成功 ├ 戀愛-->移情別戀-->痛苦-->結束 └ 戀愛-->結婚-->更大的痛苦-->無法結束 --

※ 發信站: 批踢踢實業坊(ptt.cc) ◆ From: 118.170.193.88 ※ 編輯: pharmawind 來自: 118.170.193.88 (06/24 00:54)