Rare Disease Report

Janet Woodcock Issues Statement on Safety Concerns Regarding Keytruda

AUGUST 31, 2017
James Radke
Last month, the U.S. Food and Drug Administration (FDA) put clinical holds on 2 studies involving Keytruda (pembrolizumab) in patients with multiple myeloma following an increased number of deaths being reported in those trials.

The clinical trials were:
  • KEYNOTE-183: A Phase III study of pomalidomide and low-dose Dexamethasone with or without pembrolizumab in refractory or relapsed and refractory multiple myeloma.
  • KEYNOTE-185: A Phase III study of lenalidomide and low-dose Dexamethasone with or without pembrolizumab in newly diagnosed and treatment naïve multiple myeloma.
Today, Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research (CDER) issued a statement about the hold and to clarify any safety concerns that doctors and patients may have about using Keytruda.

First, Dr. Woodcock noted that Keytruda can still be safely used to treat patients that the drug is currently approved to treat, including:
  • Malignant Melanoma (rare)
  • Lung Cancer
  • Head and Neck Cancer
  • Classical Hodgkin Lymphoma (rare)
  • Urothelial Carcinoma
  • Microsatellite Instability-High (MSI-H) Cancer
However, a clinical hold is still in place for the 2 clinical trials testing Keytruda in combination with two other therapies.

Dr Woodcock noted that the FDA is actively examining the data from the Keytruda trials and working with the develops of the drug, Merck, to determine the true cause of the safety concerns.

The FDA is also working with sponsors of other PD-1/PD-L1 inhibitors and assessing any safety concerns that have arisen when these drugs are used in combination with immunomodulatory agents.

Dr Woodcock stated that “We are communicating now, given the serious nature of the safety issue, to remind doctors and patients that Keytruda is not approved for the treatment of multiple myeloma and should not be given to patients in combination with any immunomodulatory agents, including Revlimid (lenalidomide) and Pomalyst (pomalidomide), for the treatment of multiple myeloma.”

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