Two years on from confirmatory trial halt, FDA submits more questions to Oncopeptides over Pepaxto withdrawal

Fol­low­ing up on last week’s meet­ing on FDA’s long-await­ed pro­pos­al to with­draw the ac­cel­er­at­ed ap­proval for On­copep­tides’ blood can­cer drug Pepax­to (mel­pha­lan flufe­namide), the FDA has more ques­tions on the com­pa­ny’s con­fir­ma­to­ry tri­al.

It’s been more than two years since the Swedish-based On­copep­tides first pre­sent­ed to the FDA the failed re­sults of the tri­al, known as OCEAN, fol­low­ing its 2021 ac­cel­er­at­ed ap­proval of Pepax­to as a fifth-line ther­a­py for mul­ti­ple myelo­ma.

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