[Posted 02/03/2022]
AUDIENCE: Oncology, Patient, Health Professional, Pharmacy
ISSUE: The FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib) approved to treat two specific types of lymphomas, which are cancers that affect the body's immune system. The FDA determined that initial findings from a clinical trial evaluating Ukoniq to treat a related type of cancer found a possible increased risk of death in patients taking the medicine. Because of the seriousness of this safety concern and the similarities between the two types of cancer for which this drug is approved and the type of cancer that was studied in the clinical trial, the FDA is alerting patients and health care professionals that FDA is re-evaluating this risk against the benefits of Ukoniq for its approved uses.
The FDA is continuing to evaluate the results from the clinical trial called UNITY. The FDA may also hold a future public meeting to discuss these findings and explore the continued marketing of Ukoniq. The FDA has also suspended enrollment of new patients in other ongoing clinical trials of Ukoniq while the FDA continues to review the UNITY findings. The FDA will communicate our final conclusions and recommendations when the FDA has completed the review or has more information to share.
For more information about this alert, click on the red button "Read Alert" below.
BACKGROUND: Ukoniq is a prescription medicine approved to treat adults with marginal zone lymphoma (MZL) when the disease has returned or it did not respond to prior treatment with at least one specific type of medicine. Ukoniq is also approved to treat adults with follicular lymphoma (FL) when the disease has returned or it did not respond to at least three prior treatments.
RECOMMENDATIONS:
• Health care professionals should review patients' progress on Ukoniq and discuss with them the risks and benefits of continuing Ukoniq in the context of other available treatments.
• Patients should talk to your health care professionals about the risks and benefits of Ukoniq or any concerns you may have, including about possible alternative treatments.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at: https://reurl.cc/mGKkv9
Ukoniq (umbralisib)為處方藥，美國FDA核准用於兩種淋巴癌：治療疾病復發或先前治療時曾對至少一種特定類型藥物治療沒有反應之邊緣區型淋巴癌(marginal zone lymphoma, MZL)的成人及治療疾病復發或先前曾對至少三種治療沒有反應之濾泡性淋巴癌(follicular lymphoma, FL)的成人（所謂淋巴癌為影響人體免疫系統的癌症）。美國FDA針對此癌症藥物可能增加的死亡風險正在進行調查。
美國FDA根據一項評估Ukoniq用於相關癌症的臨床試驗的初步結果發現，服用該藥的病人死亡風險可能增加。考量此安全問題的嚴重性及此藥品已核准使用的兩種癌症與臨床試驗中研究的癌症類型之相似性，美國FDA發布藥物安全警訊提醒病人和醫療專業人員，美國FDA正在重新評估Ukoniq已核准之適應症之臨床效益與其可能之相關風險。
美國FDA正在持續評估UNITY臨床試驗的結果，未來可能召開公開會議討論臨床試驗結果及評估Ukoniq是否可持續行銷使用。在審查UNITY臨床試驗結果的同時，美國FDA亦已暫停Ukoniq其他正在進行中之臨床試驗的新病人招募。一旦完成評估審查或有更多資訊時，美國FDA將提出最終結論和建議。
建議：
• 醫療專業人員應審查病人在使用Ukoniq 時的病程，並與其討論在有其他可使用之治療下繼續使用 Ukoniq的風險和益處。
• 病人應與醫療專業人員討論 Ukoniq的風險和益處或任何疑慮，包括其他可能的替代療法。
更多相關訊息與連結請參考FDA網址：https://reurl.cc/mGKkv9
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
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