Melphalan Flufenamide Withdrawn From U.S. Market

Oncopeptides AB has announced its decision to withdraw melphalan flufenamide from the U.S. market after results from the phase III OCEAN study showed an overall survival rate in the intention-to-treat population with a hazard ratio of 1.104.According to the U.S. Food and Drug Administration (FDA), the results of the OCEAN trial do not meet their criteria for a confirmatory study.

On February 26, 2021, melphalan flufenamide received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

While no new patients should begin taking melphalan flufenamide, Oncopeptides and the FDA will continue to make the drug available to patients who are currently receiving a benefit from treatment.

An application to the European Medicines Agency for a Conditional Marketing Authorization of melphalan flufenamide in the E.U., based on data from the phase II HORIZON study, remains pending.

Source: Oncopeptides press release, October 22, 2021.