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# FDA Says Pepaxto Trial Found Increased Death Risk
- URL: https://www.fdaweb.com/fda-says-pepaxto-trial-found-increased-death-risk/
- Published: 2021-07-28T12:00:00.000Z
- Updated: 2026-09-14T17:08:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149803

FDA is telling patients and healthcare professionals that the OCEAN study evaluating Oncopeptides’ Pepaxto (melphalan flufenamide) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death. An agency drug safety [alert](https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-about-clinical-trial-results-showing-increased?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the trial compared Pepaxto with low-dose dexamethasone to pomalidomide (Bristol-Myers Squibb’s Pomalyst) 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 lenalidomide (Bristol-Myers Squibb’s Revlimid) in the last line of therapy.

The agency says Pepaxto was granted accelerated approval 2/2021 for use in combination with dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease was refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

As part of the approval, Oncopeptides was required to conduct the OCEAN trial. “Due to the detrimental effect on overall survival in the OCEAN trial, FDA is requiring the manufacturer suspend enrollment in the trial,” the notice says. “FDA has also suspended enrollment in other ongoing Pepaxto clinical trials. Patients receiving clinical benefit from Pepaxto may continue treatment in the OCEAN trial provided they are informed of the risks and sign a revised written informed consent.”