Venclexta seeks to join the acute myelogenous leukaemia club

Though the small-molecule Bcl2-targeting drug Venclexta was touted as a revolutionary treatment for chronic lymphocytic leukaemia it has had a low profile since launch, eclipsed by such therapies as Imbruvica and Gazyva. So its additional development for acute myelogenous leukaemia (AML) might have gone virtually unnoticed – until now. Its joint originators, Roche and Abbvie, today said a US filing for chemo-ineligible first-line AML had been submitted; the drug is already available for second-line chronic lymphocytic leukaemia with the aggressive 17p deletion genotype. AML, an intractable cancer, has seen some progress at last, with the recent approvals of Novartis’s Rydapt, in first-line patients with FLT3 mutations, and Celgene’s Idhifa, in relapsed/refractory disease with an IDH2 mutation. Still, AML remains tough to treat, and a measure of this is the extremely early data on which Venclexta has been filed: two open-label, dose-escalation, phase I/II studies.