FDA formally pulls Oncopeptides’ cancer drug after prolonged back-and-forth

More than a year af­ter the FDA called on On­copep­tides to with­draw Pepax­to (mel­pha­lan flufe­namide), the Swedish com­pa­ny has fi­nal­ly lost its ap­peal, and the FDA is with­draw­ing the drug. Pepax­to ini­tial­ly won an ac­cel­er­at­ed ap­proval in 2021 as a fifth-line ther­a­py for the blood can­cer known as mul­ti­ple myelo­ma.

In its fi­nal de­ci­sion let­ter to On­copep­tides, dat­ed Fri­day, CBER chief Pe­ter Marks wrote that the grounds for with­draw­ing Pepax­to’s ap­proval have been met be­cause: “(1) the con­fir­ma­to­ry study con­duct­ed as a con­di­tion of ac­cel­er­at­ed ap­proval did not con­firm Pepax­to’s clin­i­cal ben­e­fit and (2) the avail­able ev­i­dence demon­strates that Pepax­to is not shown to be safe or ef­fec­tive un­der its con­di­tions of use.”

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