FDA grants fast track designation to HM43239 for leukemia subset
The FDA granted fast track designation to HM43239 for treatment of certain patients with acute myeloid leukemia.
The designation applies to use of the agent by patients with relapsed or refractory AML who harbor FLT3 mutations.
HM43239 (Aptose Biosciences) is an oral genotype-agnostic small molecule inhibitor of FLT3, SYK, mutant forms of cKIT, JAK1/JAK2 and other kinases, according to an Aptose Biosciences-issued press release.
The agent has been shown to be highly active in vivo against FLT3 internal tandem duplication, according to the release.
Results of an ongoing phase 1/phase 2 trial showed HM43239 induced complete remissions among patients with relapsed or refractory AML, including among patients who failed prior FLT3 inhibitors. The agent also appeared well-tolerated.
“Fast track status acknowledges HM43239’s potential to fill an unmet need for AML patient populations and supports our efforts as we advance it towards a potential registration study,” William G. Rice, PhD, chairman, president and CEO of Aptose Biosciences, said in the release.
The FDA granted orphan drug designation to HM43239 for AML in 2018.
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