The FDA confirmed that the treatment of second cancer was approved based on the tumor biomarker, where the tumor is located at the place where it is located.
Vitravias with NTRK (trisin kinase in the neurotrophic) may be used for the treatment of metastatic or chemotherapy with no mutation resistance to gene fusion, which will be used to treat solid tumors that can cause severe morbidity. No alternative treatment or after treatment.
NTRK genes are rare but they occur in many types of cancers, the FDA said, for example, mammary analogy constipation carcinoma and fibrosarcoma children.
Along with the tablets, the agency also admitted the diagnosis of a detection of a mutation.
"Approximately 25 to 30 percent of patients with AML, there is a mutation of the FLT3 gene, which is associated with a particularly aggressive type of disease and a greater risk of recovery," said Dr. Richard Pazdur, Director of the FDA's Oncology Center. Excellence, he said in the statement.
AML is a fast-changing cancer that helps the blood cells become normal and requires continuous transfusions.
Both treatments received a Priority Revision Appointment.
"The Priority Review Appointments will focus overall attention and resources, if approved, in the evaluation of applications for safety or efficiency in the prevention, treatment or diagnosis of serious conditions that would be significant improvements." FDA says.