Roche’s Po­livy con­tin­ues its reg­u­la­to­ry dance, will head to FDA for a form of blood can­cer

While Roche has pre­vi­ous­ly tout­ed Po­livy da­ta for dif­fuse large B-cell lym­phoma (DL­B­CL), the drug has faced some de­lays on the reg­u­la­to­ry side. But the most re­cent news from the FDA looks en­cour­ag­ing for the Swiss phar­ma.

Roche an­nounced on Tues­day that the FDA ac­cept­ed the com­pa­ny’s sup­ple­men­tal Bi­o­log­ics Li­cense Ap­pli­ca­tion for Po­livy, a Seagen-de­vel­oped ADC tar­get­ing tu­mor cells. Po­livy is be­ing used in tan­dem with Rit­ux­an as well as cy­clophos­phamide, dox­oru­bicin and pred­nisone (R-CHP) for the treat­ment of pa­tients with DL­B­CL. The FDA is ex­pect­ed to hand down its ver­dict on the com­bi­na­tion by April of next year, ac­cord­ing to the com­pa­ny.

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