The US Food and Drug Administration (FDA) has issued a statement clarifying its position on Keytruda (pembrolizumab) after scientists monitoring studies of the drug found an excess of deaths among patients given the drug in combination with certain other medicines.
Currently, Keytruda is indicated for a number of cancer treatments, including melanoma; non-small cell lung cancer; head and neck squamous cell cancer; Hodgkin lymphoma; and certain bladder and urinary tract cancers. In May 2017, the drug was granted accelerated approval as a treatment for patients whose cancer has a specific biomarker.
Concerns were raised following two clinical trials into the use of Keytruda in combination with two other therapies in the treatment of multiple myeloma. The FDA announced it is examining data from the latest trials and is working alongside Merck to get a full understanding of the cause of the safety concerns. It also asserted it would take "appropriate action" to ensure patients enrolled in trials are properly protected.
Once safety concerns emerged in June 2017, Merck and the FDA took immediate action to protect patients, ceasing further enrollment in trials. Last month, the FDA acted on data from Merck to put a full clinical hold on the trials, ceasing further treatment with Keytruda in the trials.
This move was described as an "important first for the cancer community" by Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and director of the FDA's Oncology Center of Excellence.
"We… want to ensure that patients taking Keytruda and other PD-1/PD-L1 inhibitors know that the FDA still believes the benefits of taking these drugs for their approved uses and as indicated in the labels continue to outweigh their risks," stated Janet Woodcock, director of the Center for Drug Evaluation and Research.
Patients currently taking Keytruda for their approved uses were approved to continue taking their medication as directed by their healthcare provider. However, the FDA highlighted that the drug is not approved for treating multiple myeloma, stating it should not be administered with any immunomodulatory agents, such as Pomalyst (pomalidomide) and Revlimid (lenalidomide).
Merck's Keytruda clinical development program includes more than 30 tumor types in more than 550 clinical trials, which include more than 300 examining combination treatment using Keytruda and other cancer treatments. Last month, Merck announced it would present studies involving Keytruda in 12 different types of cancer at the European Society for Medical Oncology 2017 Congress in Madrid between September 8th-12th.