Bris­tol-My­ers, Ab­b­Vie's mul­ti­ple myelo­ma drug wins sec­ond EU nod as part of triple reg­i­men

Less than a year af­ter the FDA cleared Bris­tol-My­ers Squibb $BMY and Ab­b­Vie’s $AB­BV ap­proved Em­plic­i­ti in­jec­tion for in­tra­venous use in com­bi­na­tion with Cel­gene’s $CELG po­ma­lido­mide (Po­m­a­lyst, or Im­novid, de­pend­ing on which side of the At­lantic you are) and the steroid dex­am­etha­sone for re­lapsed, re­frac­to­ry mul­ti­ple myelo­ma, the Eu­ro­pean Com­mis­sion has fol­lowed suit.

The ap­proval is based on da­ta from the 117 pa­tient-ELO­QUENT-3 tri­al in which the triplet dou­bled both me­di­an pro­gres­sion-free sur­vival (PFS) and over­all re­sponse rate (ORR) among pa­tients with re­lapsed and re­frac­to­ry mul­ti­ple myelo­ma, ver­sus po­ma­lido­mide and low-dose dex­am­etha­sone alone.

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