FDA reinforces warning about Keytruda in multiple myeloma

1 September 2017

Based on data from two clinical trials halted about two months ago, the US Food and Drug Administration on Thursday issued a 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.

US pharma giant Merck & Co’s (NYSE: MRK) already blockbuster cancer drug Keytruda is not approved for treatment of multiple myeloma. Sales of the drug nearly tripled to $881 million in the second quarter of 2017, beating consensus estimates of $777 million.

Merck stopped enrolling multiple myeloma patients in the trials in June and notified the FDA. Shortly thereafter, the agency placed a full hold on these trials and patients are no longer receiving treatment.

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