The first monotherapy for leukemia received FDA approval

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The US FDA has approved gilteritinib Xospata ) for the treatment of adult patients with FLT3 mutation-positive relapse or refractory acute myeloid leukemia ( AML ).

When used with gilteritinib , it also awards companion diagnostic genetic testing technology. The LeukoStrat CDx FLT3 mutation detection method developed by Invivoscribe Technologies , Inc. is used to detect FLT3 mutations in AML patients .

“About 25 % -30 % of AML patients with FLT3 mutated genes, ” FDA Drug Administration Center for FDA director of the Oncology and Hematology and Oncology Center product acting director Richard Pazdur , MD, and Research, said in a statement. These mutations are particularly associated with cancer aggressiveness and a higher risk of recurrence. “

Pazdur added that gilteritinib is the first approved drug to be used as a monotherapy in AML patient populations.

FLT3 is the most frequently mutated gene identified in AML ,and FLT3 internal tandem repeat mutations are associated with high relapse rates, short remissions, and poor survival outcomes. Gilteritinib is a highly selective FLT3 tyrosine kinase inhibitor that has been shown to have activity against FLT3 ITD mutations, and also inhibits FLT3 D835 mutations that can confer clinical resistance to other FLT3 inhibitors .

The 252 patients enrolled in the early phase 1/2 trial showed that 49 % of patients with relapsed or refractory AML and FLT3 mutations responded to gilteritinib . The median survival of these participants was more than 7 months. Only 12 % of patients without FLT3 mutations responded to gilteritinib , providing evidence that it can be used as a selective inhibitor of mutant FLT3 .

The approval was based on data from the ADMIRAL study, a randomized phase 3 trial in which 138 adult patients with FLT3- positive relapsed / refractory AML received 120 mg of oral gefitinib daily . In this group, 21 % of patients achieved complete remission or complete remission with partial hematological recovery. The ADMIRAL trial itself is still in progress, and detailed response and overall survival data are expected to be published next year.

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