Pfizer’s Elrexfio, Astellas’ Veozah among new drugs recommended for authorization by European regulatory committee

The Eu­ro­pean Med­i­cines Agency’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) this week rec­om­mend­ed sev­en new drugs for au­tho­riza­tion, in­clud­ing Pfiz­er’s po­ten­tial mul­ti­ple myelo­ma block­buster el­ranatam­ab and Astel­las’ hot flash treat­ment fe­zo­line­tant.

El­ranatam­ab, mar­ket­ed as El­rex­fio, won an ac­cel­er­at­ed ap­proval in the US in Au­gust for re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma pa­tients who’ve had at least four pri­or ther­a­pies, in­clud­ing a pro­tea­some in­hibitor, an im­munomod­u­la­to­ry agent and an an­ti-CD38 mon­o­clon­al an­ti­body. Eu­ro­pean reg­u­la­tors are con­sid­er­ing El­rex­fio for con­di­tion­al au­tho­riza­tion af­ter just three pri­or ther­a­pies, and Pfiz­er has made clear that it’s fo­cused on ex­tend­ing the drug in­to ear­li­er lines of ther­a­py.

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