The OCEAN study evaluating melphalan flufenamide and dexamethasone for the treatment of patients with multiple myeloma (MM) found an increased risk of death, according to a U.S. Food and Drug Administration (FDA) alert.
The FDA requires that Oncopeptides AB, the manufacturer of melphalan flufenamide, suspend enrollment in the OCEAN trial and other ongoing clinical trials involving the treatment. Patients currently receiving clinical benefit from melphalan flufenamide may continue treatment in the OCEAN trial after being informed of these risks and signing a revised written informed consent.
Melphalan flufenamide was approved by the FDA in February 2021 for use in combination with dexamethasone to treat adult patients with relapsed or refractory MM 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. The OCEAN trial was conducted as a post-approval requirement under the FDA’s accelerated approval program.