CDER chal­lenges On­copep­tides’ ap­peal over Pepax­to with­draw­al

FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search is ob­ject­ing to On­copep­tides’ ap­peal of the agency’s re­quest to with­draw its can­cer drug Pepax­to.

Pepax­to was first grant­ed ac­cel­er­at­ed ap­proval in Feb­ru­ary 2021 for the fifth-line treat­ment of mul­ti­ple myelo­ma in com­bi­na­tion with dex­am­etha­sone. How­ev­er, the FDA halt­ed On­copep­tides’ con­fir­ma­to­ry tri­als in Ju­ly of that year af­ter not­ing an in­creased risk of death among pa­tients who took a Pepax­to and dex­am­etha­sone com­bi­na­tion. On­copep­tides ini­tial­ly in­di­cat­ed it would with­draw the drug from the mar­ket, but quick­ly re­versed course.

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