November 28, 2018
The U.S. Food and Drug Administration approved a new drug treatment for some leukemia patients on Wednesday.
The drug, gilteritinib, will benefit relapses or refractory acute myeloid leukemia patients whose disease has undergone an FLT3 gene mutation, the most common mutation associated with the disease. The drug, sold under the name Xospata, was clinically tested at the University of Pennsylvania.
About 19,000 people are diagnosed with acute myeloid leukemia each year, according to the American Cancer Society. The FLT3 gene mutation is found in about 30 percent of patients' leukemia cells.
Leukemia patients with these mutations have low response rates to chemotherapy if the disease relapses. But gilteritinib offers them another option.
The FLT3 gene mutation causes cancer cells to grow in an uncontrolled manner. Gilteritinib prevents the gene mutation from functioning.
“Today’s approval brings a new, highly-effective and well-tolerated treatment option to the clinic for a group of truly high-risk patients who, until today, had no specific therapies available beyond chemotherapy to treat their disease,” said Dr. Alexander Perl, who led clinical trials.
The drug comes in pill form and should be taken once a day. It is manufactured by Astellas Pharma.