Kura gets a safety edge over Syndax

Kura, which has long claimed that its menin inhibitor ziftomenib could be safer than Syndax’s rival drug Revuforj, can now back this up. The FDA has just approved ziftomenib (now branded Komzifti) for relapsed/refractory AML with NPM1 mutations – the same indication for which Revuforj got the nod last month. But, unlike Revuforj, Komzifti has avoided a boxed warning for the cardiac side effects QTc prolongation and Torsades de Pointes. The newly approved drug still carries a regular warning for QTc prolongation, as well as a boxed warning for differentiation syndrome – the latter is seen as a class effect of menin inhibitors. Kura and its partner Kyowa Kirin will hope that this safety profile will give Komzifti an edge over Revuforj in terms of sales, as the drugs have produced similar efficacy in their registrational trials, Komet-001 and Augment-101 respectively. Kura also noted that Komzifti was given once daily, while Revuforj is a twice-daily pill. Revuforj, first approved last year for KMT2Ar leukaemia, sold $32m in the third quarter. The next battleground will be first-line AML, where combo studies are under way, and where Johnson & Johnson’s bleximenib is also challenging.

Approved menin inhbitors

Source: product labels.