AbbVie, Roche's Venclexta endangers AML approval with flopped confirmatory trial

AbbVie, Roche's Venclexta endangers AML approval with flopped confirmatory trial

Source: 
Fierce Pharma
snippet: 

AbbVie and Roche notched a big win for blood cancer therapy Venclexta with a late 2018 FDA approval in the ultra-competitive acute myeloid leukemia market. But with only an early-stage trial to its name, Venclexta's approval was conditional—and a failed confirmatory trial could now jeopardize its green light.