FDA publishes Oncopeptides’ withdrawal appeal for Swedish biotech’s cancer drug Pepaxto

On­copep­tides’ ap­peal to the FDA’s with­draw­al pro­pos­al for the blood can­cer drug Pepax­to has been made pub­lic, shed­ding new light on the see­saw­ing that’s been go­ing on at the Swedish biotech.

Pepax­to has been on a rocky jour­ney since its ac­cel­er­at­ed ap­proval in ear­ly 2021 for use in com­bi­na­tion with dex­am­etha­sone as a fifth-line treat­ment for adults with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma. The FDA alert­ed pa­tients in the sum­mer of 2021 that the con­fir­ma­to­ry tri­al was halt­ed af­ter con­cerns of in­creased risk of death in pa­tients tak­ing a com­bi­na­tion of Pepax­to (mel­pha­lan flufe­namide) and dex­am­etha­sone. FDA’s re­view­ers con­clud­ed that a con­fir­ma­to­ry tri­al did not show safe and ef­fi­ca­cious treat­ment ben­e­fit.

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