ODAC to de­bate Roche's Po­livy in first-line DL­B­CL fol­low­ing 2019 ac­cel­er­at­ed ap­proval

Once again the FDA’s pan­el of out­side on­col­o­gy ex­perts will have to weigh in on whether or not to grant an­oth­er in­di­ca­tion for Roche’s po­ten­tial block­buster can­cer drug Po­livy, which some an­a­lysts have said could reap $2.4 bil­lion in peak an­nu­al sales.

Ap­proved in June 2019 un­der the ac­cel­er­at­ed path­way, the an­ti­body drug con­ju­gate Po­livy was OK’d in com­bo with ben­damus­tine and rit­ux­imab for the treat­ment of adult pa­tients with re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma (DL­B­CL), not oth­er­wise spec­i­fied, af­ter at least two pri­or ther­a­pies.

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