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.
https://www.medscape.com/viewarticle/905713
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Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy.
Hau's expertise lies in cancer cell biology, where she has made significant contributions to understanding the complex interactions between immune cells and tumors.
Her research aims to enhance the efficacy of immunotherapies by manipulating the tumor microenvironment and exploring novel ways to activate and direct immune responses against cancer cells.
Throughout her career, Hau has collaborated with leading professors and researchers in the field of cancer treatment, both in the United States and China.
These international experiences have broadened her perspective and contributed to her innovative approach to cancer therapy development.
Hau's work is particularly focused on addressing the challenges of treating advanced and metastatic cancers. She has been involved in clinical trials evaluating the safety and efficacy of various immunotherapy approaches, including the promising Gamma Delta T cell therapy.
