FDA ad­comm votes 11-2 to ex­pand Roche's Po­livy la­bel in DL­B­CL

An FDA com­mit­tee of out­side can­cer ex­perts vot­ed 11-2 Thurs­day that the FDA should ex­pand Roche’s Po­livy la­bel to in­clude it as a treat­ment in com­bo with rit­ux­imab, cy­clophos­phamide, dox­oru­bicin, and pred­nisone (R-CHP) for the treat­ment of adult pa­tients with pre­vi­ous­ly un­treat­ed dif­fuse large B-cell lym­phoma (DL­B­CL).

The pos­i­tive On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee (ODAC) vote for the an­ti­body-drug con­ju­gate fol­lowed a four hour-plus meet­ing where the ad­comm hashed out con­cerns high­light­ed in brief­ing doc­u­ments re­leased by FDA. Those con­cerns in­clud­ed is­sues like a mod­est ben­e­fit in pro­gres­sion-free sur­vival, over­all sur­vival rates, and lim­i­ta­tions in ef­fi­ca­cy end­points.

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