Kura Oncology already had a broad development plan for ziftomenib in leukemias, but the agreement with Kyowa Kirin provides the cash to execute it and a partner to commercialize the drug globally. Ziftomenib is in the same class of medicines as Syndax Pharmaceuticals’ Revuforj, which won FDA approval last week.
The FDA placed the partial hold on the study last November following a patient death suspected to be linked to a known complication of leukemia therapies. Kura Oncology said it has reached agreement with the FDA on a mitigation strategy for that complication.
The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients.
The FDA placed a partial clinical hold on a Kura Oncology leukemia drug following the death of one patient in the early-stage study. Kura executives said the death may be related to differentiation syndrome, a known complication of leukemia therapies.