Ab­b­Vie, Roche post a big win with a block­buster FDA OK for Ven­clex­ta/Rit­ux­an com­bo for leukemia

Roche’s on­col­o­gy team has post­ed an­oth­er reg­u­la­to­ry win.

The phar­ma gi­ant — al­lied with Ab­b­Vie — says the FDA has ap­proved a com­bi­na­tion of Ven­clex­ta and Rit­ux­an as a sec­ond-line ther­a­py for chron­ic lym­pho­cyt­ic leukemia or small lym­pho­cyt­ic lym­phoma. This is the first chemo-free oral com­bi­na­tion with a fixed treat­ment du­ra­tion for CLL.

Ab­b­Vie and Roche are part­nered on Ven­clex­ta.

The ap­proval is based on the stel­lar da­ta gar­nered in their Phase III MU­RA­NO study, in which the com­bo sparked an 81% re­duc­tion in the risk of death or dis­ease pro­gres­sion com­pared to Rit­ux­an and chemo. In the tri­al, the 24-month PFS rate hit 84.9% for the Ab­b­Vie $AB­BV/Roche $RHH­BY com­bo against 36.3% for chemo/Rit­ux­an. And the com­plete re­sponse rate — no sign of the dis­ease — reg­is­tered at 26.8% against 8.2%.

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