FDA alerts patients and health care professionals about clinical trial results showing an increased risk of death associated with Pepaxto (melphalan flufenamide) - CDER Alert
ISSUE: FDA is alerting patients and health care professionals that a clinical trial (OCEAN, Study OP-103) evaluating Pepaxto (melphalan flufenamide) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death.
The trial compared Pepaxto with low-dose dexamethasone to pomalidomide with low-dose dexamethasone in patients with relapsed or refractory (resistant) multiple myeloma following 2-4 lines of prior therapy and in patients who were resistant to lenalidomide in the last line of therapy.
BACKGROUND: In February 2021, FDA approved Pepaxto for use in combination with dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease was refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
RECOMMENDATIONS:
• FDA encourages health care professionals to review patients' progress on Pepaxto and discuss the risks of continued administration with each patient in the context of other treatments.
• Patients currently receiving Pepaxto should also discuss with their health care professional the risks and benefits of receiving Pepaxto.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-about-clinical-trial-results-showing-increased?utm_medium=email&utm_source=govdelivery
美國FDA於2021年2月加速核准Pepaxto（melphalan flufenamide）與dexamethasone併用於治療已至少使用4線治療且曾使用一種蛋白酶體抑制劑(proteasome inhibitor)、一種免疫調節藥品及一種CD38導向之單株抗體，疾病仍復發之復發型或頑固型多發性骨髓瘤成人患者。並要求廠商需執行上市後的臨床試驗(OCEAN trial) 。
美國FDA提醒患者和醫療專業人員，Pepaxto（melphalan flufenamide）治療多發性骨髓瘤的臨床試驗（OCEAN，其研究又名OP-103），結果顯示Pepaxto可能增加多發性骨髓瘤的死亡風險。該試驗比較Pepaxto合併低劑量dexamethasone與pomalidomide合併低劑量dexamethasone於先前已接受2-4線治療後的復發型或頑固型多發性骨髓瘤患者及最後一線治療中對lenalidomide無效的患者。
建議：
• 美國FDA鼓勵醫療專業人員回顧病人使用Pepaxto後疾病的進展，並在有其他治療的狀況下與每位患者討論繼續給藥的風險。
• 目前正在接受Pepaxto治療的患者應與其醫療專業人員討論持續接受Pepaxto治療的風險和益處。
[Posted 07/28/2021]
更多相關訊息與連結請參考FDA網址：https://reurl.cc/EZZpOm
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
回首頁 |
