Oncopeptides Withdraws Pepaxto from U.S. Market

Oncopeptides has decided to withdraw Pepaxto (melphalan flufenamide) from the market in the United States. FDA officials don’t believe that the phase 3 study meets the standards of a confirmatory trial.

The FDA granted accelerated approval for Pepaxto on Feb. 26, 2021 in combination with dexamethasone, 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.

In May, the company released data from the OCEAN study, which found that positive topline results evaluating the efficacy and safety of Pepaxto versus pomalidomide in patients with relapsed refractory multiple myeloma.

Company officials, however, believe the data are scientifically meaningful, and the application in European is pending. But as a result of the FDA decision, Oncopeptides will close down its business units in the United States and Europe to focus exclusively on being a Sweden-based R&D company.

“The decision to withdraw Pepaxto from the market has been a difficult decision, that has been made with great consideration and with the best intentions for patients and shareholders,” says Marty J. Duvall, chief executive officer at Oncopeptides, said in a statement.”The company now needs to refocus its resources and energy on R&D and remain true to its mission of bringing hope to patients through science. We believe that this is the only viable path forward to accomplish this goal.”