AbbVie, Roche's Venclexta endangers AML approval with flopped confirmatory trial
AbbVie and Roche's Venclexta secured an FDA approval for acute myeloid leukemia in late 2018. (AbbVie)
AbbVie and Roche notched a big win for blood cancer therapy Venclexta with a late 2018 FDA approval in the ultracompetitive acute myeloid leukemia (AML) 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.
A combo of Venclexta and low-dose chemotherapy cytarabine (LDAC) failed to significantly extend AML patients' lives over LDAC alone in a phase 3 trial meant to confirm Venclexta's approval, AbbVie said Friday.
The Venclexta-LDAC combo posted a 25% reduction in the risk of death over solo LDAC and extended patients' lives by a median 7.2 months compared with 4.1 months in the LDAC arm, AbbVie said.
The company has submitted data from the phase 3 Viale-C study to the FDA and global regulators, it said, with Neil Gallagher, AbbVie's chief medical officer and VP of development, adding in a statement that the results, "while not statistically significant, are indicative of the clinical activity" of the pairing.