Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold
ISSUE: Based on data from two recently halted clinical trials, the U.S. Food and Drug Administration today is issuing this statement to inform the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma.
The FDA statement is based on review of data from two clinical trials (KEYNOTE-183 and KEYNOTE-185) evaluating the use of Keytruda (pembrolizumab) combined with other treatments in patients with multiple myeloma. On July 3, 2017, the FDA required that all patients in these trials be discontinued from further investigation with this drug, because interim results from both trials demonstrated an increased risk of death for patients receiving Keytruda (pembrolizumab) when it was combined with an immunomodulatory agent as compared to the control group (see statistical analysis section below). Merck & Co., Inc. was made aware of the issue through an external data monitoring committee recommendation and suspended the trials to enrollment on June 12, 2017.
BACKGROUND: This does not apply to patients taking Keytruda (pembrolizumab) for an approved indication. Patients on Keytruda (pembrolizumab) for an approved use should continue to take their medication as directed by their health care professional.
Keytruda (pembrolizumab) is currently approved by the FDA for treatment of: Melanoma, Lung Cancer, Head and Neck Cancer, Classical Hodgkin Lymphoma, Urothelial Carcinoma, Microsatellite Instability-High (MSI-H) Cancer.
For a summary of the statistical analysis and findings, please refer to the FDA Statement.
RECOMMENDATION: Other multiple myeloma clinical trials of Keytruda (pembrolizumab), other PD-1/PD-L1 cancer drugs and other combinations are currently undergoing clinical evaluation. The FDA will be working directly with sponsors of Keytruda and other PD-1/PD-L1 cancer drugs, as well as clinical investigators conducting clinical trials in patients with multiple myeloma, to determine the extent of the safety issue. The agency will communicate any new information to the public as soon as it is able.
Read the MedWatch safety alert at:
根據近期終止的兩個臨床試驗，美國FDA發布Keytruda (pembrolizumab)合併dexamethasone及免疫調節劑(lenalidomide或pomalidomide)，用以治療多發性骨髓瘤(multiple myeloma)之相關警訊。美國FDA發布此警訊是根據回顧近期兩個臨床試驗(KEYNOTE-183以及KEYNOTE-185)，評估多發性骨髓瘤病人使用Keytruda (pembrolizumab)合併其他治療之效果。此兩臨床試驗之期中分析發現使用Keytruda (pembrolizumab)合併其他治療，相較於安慰劑組，其死亡風險較高，因此2017年7月3日美國FDA要求此兩個臨床試驗之病人，停止使用此治療；此研究也已於2017年6月暫停納入新病人。Keytruda (pembrolizumab)目前尚未被美國FDA核可用以治療多發性骨髓瘤。
目前Keytruda (pembrolizumab)於美國已核准用於黑色素瘤(Melanoma)、肺癌(Lung Cancer)、頭頸癌(Head and Neck Cancer)、典型何杰金氏淋巴癌(Classical Hodgkin Lymphoma), 泌尿道上皮細胞癌(Urothelial Carcinoma), 微小衛星體高度不穩定性之癌症(Microsatellite Instability-High (MSI-H) Cancer)。此資訊並不適用於使用Keytruda (pembrolizumab)於美國FDA核准適應症之病人，故使用Keytruda (pembrolizumab)於美國FDA核准適應症之病人仍因遵照醫療專業人員指示，持續使用Keytruda (pembrolizumab)。