Ab­b­Vie/Roche's Ven­clex­ta wins fourth ap­proval; WuXi, fel­low CRO Al­ta­sciences ink deal

→ Ab­b­Vie and Roche’s blood can­cer drug, Ven­clex­ta, has notched a fourth ap­proval. On Wednes­day, Ab­b­Vie $AB­BV said the drug was ap­proved in com­bi­na­tion with Genen­tech’s Gazy­va for treat­ment-naive pa­tients with chron­ic lym­pho­cyt­ic leukemia (CLL) or small lym­pho­cyt­ic lym­phoma (SLL). “The ap­proval is based on find­ings from the CLL14 tri­al in which pa­tients re­ceived a 12-month treat­ment reg­i­men. The ma­jor­i­ty of pa­tients re­ceiv­ing Ven­clex­ta in the tri­al re­mained pro­gres­sion-free at two years,” said Michael Sev­eri­no, Ab­b­Vie’s vice chair­man and pres­i­dent, in a state­ment. Ven­clex­ta was first ap­proved in 2016 by the FDA un­der the ac­cel­er­at­ed ap­proval path­way for use in cer­tain pa­tients with CLL — it is now sanc­tioned for use in more than 50 coun­tries and gen­er­at­ed $344 mil­lion in glob­al sales last year.

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