FDA stamps fast OK on Astellas' pioneering FLT3 AML drug gilteritinib, expanding on a record year for new approvals
Astellas has picked up boasting rights to gaining the first FDA approval of a FLT3 inhibitor for a specific group of FLT3 positive acute myeloid leukemia patients — which accounts for close to a third of the population.
Back in May the Japanese pharma reported that the agency had offered a snap 6-month review on its fast-track program for gilteritinib, something that’s become quite common in the oncology group.
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