The FDA said in a statement that another approved cancer treatment treatment based on a tumor biomarker instead of a site in the body where the tumor arose.
Vitraclavs will be used to treat solid tumors that have a phosphate NTRK gene fusion (neurotrophic receptor tyrosine kinase) that do not have a known metastatic resistance mutation or where surgical removal can lead to severe morbidity, which has no alternative treatments or has progressed after treatment.
NTRK genes are rare but occur in many types of cancers, said the FDA, such as secretarial secretariats and infantile fibrosarcoma.
In addition to the tablet, the agency also approved diagnostics to detect the mutation.
"About 25 to 30 percent of patients with AML have a mutation in the FLT3 gene, and these mutations are associated with particularly aggressive forms of the disease and a higher risk of relapse," said Dr. Richard Pazdur, director of the FDA's Oncology Excellence Center, said in a statement.
AML is a rapidly progressive cancer that affects the number of normal blood cells and calls for continuous transfusions, the FDA said.
Both treatments received a priority check mark.
"The priority label will direct general attention and resources to the evaluation of drug applications, which, if approved, will make significant improvements in the safety or effectiveness of treatment, diagnosis or prevention of serious conditions compared to standard applications," the FDA says.