PrECOG 0905 Trial: Gefitinib vs. Midotuximab Plus Intensive Chemotherapy for Newly Diagnosed FLT3-Mutant Acute Myeloid Leukemia – aml-hub.com

Gefitinib was first approved by the U.S. FDA in 2015 for the treatment of patients with non-small cell lung cancer with specific EGFR mutations.

Gefitinib is a prescription drug approved for marketing in the United States in November 2018. It targets FMS-like tyrosine kinase 3 (FLT3) and its mutations (including FLT3-ITD and FLT3-TKD such as D835Y, I836, etc.). It should be used in strict accordance with the doctor's instructions.

Gipritinib is a potent, selective, oral FMS-like tyrosine kinase 3 (FLT3) inhibitor. The approval of gipritinib was based on the global, multicenter, open-label, randomized, controlled phase III clinical trial ADMIRAL, which ultimately enrolled 371 patients with relapsed or refractory AML who had FLT3 mutations detected in their blood or bone marrow. These patients were randomized 2:1 to receive either gipritinib or salvage chemotherapy. The primary composite endpoint of the ADMIRAL study was overall survival (OS) and the rate of complete remission (CR/CRh) with complete or partial hematologic recovery. The results of this study were published in the prestigious medical journal *The New England Journal of Medicine* (NEJM).