On October 22, Oncopeptides announced its decision to withdraw melphalan flufenamide (Pepaxto), a first-in-class peptide-drug conjugate, from the market in the United States, following results from the phase III OCEAN study in patients with relapsed or refractory multiple myeloma. The decision to withdraw was made after interactions and dialogue with the U.S. Food and Drug Administration (FDA); melphalan flufenamide was granted accelerated approval by the agency on February 26, 2021.
In a press release from the company, Oncopeptides representatives wrote, “During our dialogue with FDA, it has become evident that the FDA does not consider that the phase III OCEAN study meets the criteria of a confirmatory study.” Oncopeptides will immediately refocus as a company and return to being a Sweden-based R&D company, dedicated to further develop its proprietary peptide drug-conjugate platform.
An application to the European Medicines Agency for a potential conditional marketing authorization of melflufen (melphalan flufenamide) in the European Union based on the pivotal phase II HORIZON study in patients with relapsed or refractory multiple myeloma remains pending.
Oncopeptides will work together with the FDA to continue to make the drug available for patients currently treated with melphalan flufenamide.
