FDA green­lights Roche's Po­livy, ex­pand­ing la­bel in­to first-line DL­B­CL com­bo ther­a­py

Roche and Genen­tech an­nounced Wednes­day that the FDA ap­proved its an­ti­body-drug con­ju­gate Po­livy, com­bined with the can­cer reg­i­men known as R-CHP, for first-line use in dif­fuse large B-cell lym­phoma, or DL­B­CL.

The la­bel ex­pan­sion is for adults with pre­vi­ous­ly un­treat­ed DL­B­CL, not oth­er­wise spec­i­fied (NOS) or high-grade B-cell lym­phoma (HB­CL) or those with an In­ter­na­tion­al Prog­nos­tic In­dex (IPI) score — de­vel­oped to bet­ter pre­dict out­comes of non-Hodgkin’s lym­phoma pa­tients — of two or greater. Reg­u­la­tors al­so con­vert­ed Po­livy’s pre­vi­ous ac­cel­er­at­ed ap­proval in­to a full ap­proval, for re­lapsed or re­frac­to­ry DL­B­CL af­ter at least two pri­or ther­a­pies. That orig­i­nal in­di­ca­tion was ap­proved in 2019.

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