In halt­ing con­fir­ma­to­ry tri­al for On­copep­tides' ac­cel­er­at­ed ap­proval, FDA notes in­creased risk of death

The FDA on Wednes­day morn­ing alert­ed pa­tients and health­care pro­fes­sion­als that the con­fir­ma­to­ry tri­al for On­copep­tides’ mul­ti­ple myelo­ma drug Pepax­to (mel­pha­lan flufe­namide) has been halt­ed, as the com­bi­na­tion of Pepax­to and dex­am­etha­sone showed an in­creased risk of death.

The con­fir­ma­to­ry tri­al, re­quired as a con­di­tion of Pepax­to’s ac­cel­er­at­ed ap­proval in Feb­ru­ary and known as OCEAN, com­pared Pepax­to and low-dose dex­am­etha­sone with Bris­tol My­ers Squibb’s Po­m­a­lyst (po­ma­lido­mide) with low-dose dex­am­etha­sone in pa­tients with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma, fol­low­ing 2-4 lines of pri­or ther­a­py and in pa­tients who were re­sis­tant to lenalido­mide in the last line of ther­a­py.

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