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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