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.
De-risking the Development of Biotherapeutics Using Early Stage In Vitro Expression and Genetic Characterisation Tools
Wednesday, July 8, 2020 | 11am EST / 8am PST
This webinar will describe strategies to mitigate risks, reduce attrition and help improve the quality and safety of your drug candidate.
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.