ODAC gives a big thumbs-down to On­copep­tides' dan­gling ac­cel­er­at­ed ap­proval in mul­ti­ple myelo­ma

ODAC on Thurs­day vot­ed over­whelm­ing­ly against keep­ing the ac­cel­er­at­ed ap­proval for On­copep­tides’ Pepax­to, 14 vot­ing “no,” and 2 “yes” to the FDA’s ques­tion of: “Is the ben­e­fit-risk pro­file of mel­pha­lan flufe­namide fa­vor­able for the cur­rent­ly in­di­cat­ed pa­tient pop­u­la­tion?”

It’s been more than 15 months since Swe­den-based On­copep­tides first pre­sent­ed to the FDA its failed re­sults from a con­fir­ma­to­ry tri­al, known as OCEAN, fol­low­ing its 2021 ac­cel­er­at­ed ap­proval of Pepax­to (mel­pha­lan flufe­namide) as a fifth-line ther­a­py for mul­ti­ple myelo­ma.

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