Roche with­draws EMA ex­pan­sion ap­pli­ca­tion for can­cer med­i­cine Gazy­varo af­ter lack of 'ro­bust' tri­al meth­ods

Roche pulled its mar­ket­ing au­tho­riza­tion ap­pli­ca­tion with the Eu­ro­pean Med­i­cines Agency (EMA) ear­li­er this month to ex­pand the la­bel for its can­cer med­i­cine Gazy­varo, be­cause the sub­mit­ted da­ta didn’t al­low the Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) to “con­clude on a pos­i­tive ben­e­fit/risk pro­file” for the drug.

Roche had hoped to get the in­di­ca­tion for Gazy­varo ex­pand­ed as a pre-treat­ment to re­duce the risk of cy­tokine re­lease syn­drome in pa­tients tak­ing Columvi (glofi­ta­m­ab), a can­cer med­i­cine used to treat adults with the blood can­cer dif­fuse large B-cell lym­phoma. The syn­drome is an im­mune sys­tem re­ac­tion that can be fa­tal.

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