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FDA Safety Alert: Pepaxto is Associated with Increased Risk of Death


The agency has stopped enrollment in all ongoing trials.

The FDA is alerting health care professionals that a clinical trial has shown that Pepaxto (melphalan flufenamide) with dexamethasone increased the risk of death.

The trial, OCEAN, Study OP-103, compared Pepaxto with low-dose dexamethasone to Pomalyst (pomalidomide) with low-dose dexamethasone in patients with relapsed or refractory multiple myeloma following two to four lines of prior therapy and in patients who were resistant to (Revlimid) lenalidomide.

Regulatory officials have required the manufacturer, Oncopeptides, to suspend enrollment in this and other ongoing Pepaxto trials. Patients in the OCEAN will be able to continue if they sign a revised written informed consent.

Company officials said in a statement that patient safety is paramount and they have ongoing dialogue with the FDA and will provide updated information as soon as more information becomes available. They say this plan to submit complete data from the OCEAN-study to the International Myeloma Workshop meeting in Vienna, Austria, on September 8-11, 2021.

The FDA granted accelerated approval to Pepaxto in February 2021. Oncopeptides was required to conduct the OCEAN trial as a post-approval requirement under the accelerated approval program.

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