**Due to an update in May 2019 to the FDA.gov website, provided links may not appropriately redirect. Please visit www.fda.gov/drugs/drug-safety-and-availability to see the most recent FDA Medication Safety Alerts and Safety Communications or to search for specific alerts or communications.**
Pembrolizumab (Keytruda) in combination with dexamethasone and either lenalidomide or pomalidomide increased the risk of death in patients with multiple myeloma based on interim analyses from 2 phase 3 clinical trials. FDA issued a MedWatch alert to inform clinical trial investigators, health care providers, and members of the public concerning this risk. Merck & Co., the manufacturer of Keytruda, halted the KEYNOTE-183 and KEYNOTE-185 trials on June 12, 2017 after an external data monitoring committee performed a safety analysis showing that patients in the pembrolizumab groups were at an increased risk of death compared with control groups. The analysis included 259 patients from the KEYNOTE-183 trial and 301 patients from the KEYNOTE-185 trial. The relative risk of death for patients taking pembrolizumab increased by more than 50% in KEYNOTE-183 trial and more than doubled in KEYNOTE‑185 trial when compared with patients in the control groups. FDA mandated that all patients in these trials discontinue pembrolizumab on July 3, 2017.
Pembrolizumab is not labeled to treat multiple myeloma. Patients receiving pembrolizumab for a labeled indication should continue therapy. Labeled indications for pembrolizumab include head and neck cancers, Hodgkin lymphoma, lung cancers, melanoma, microsatellite instability-high cancer, and urothelial carcinoma.
Pembrolizumab is being studied in other clinical trials in patients with multiple myeloma. FDA will continue to work with Merck & Co. and investigators of other clinical trials to assess patient safety in ongoing trials of pembrolizumab for the treatment of multiple myeloma.
More information is available at the following links:
- FDA Medwatch Alert – August 31, 2017
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574347.htm - FDA Safety Alert – August 31, 2017
www.fda.gov/Drugs/DrugSafety/ucm574305.htm