The FDA said in a statement that it is the second approved cancer therapy, which is based on a tumor biomarker instead of the place in the body where the tumor originated.
Vitrakvi will be used to treat solid tumors that have a fusion of the NTRK genes (neurotrophic receptor tyrosine kinase) that do not have a known resistance mutation that are not metastatic or where surgical removal can lead to severe morbidity and which have no alternative treatment methods or progressed after treatment .
NTRK genes are rare, but are found in many types of cancer, the FDA said, for example, secretory carcinoma of the breast and infantile fibrosarcoma.
Along with the pills, the agency also approved the diagnosis for detecting mutations.
“Approximately 25-30% of patients with AML have a mutation in the FLT 3 gene. These mutations are associated with a particularly aggressive form of the disease and a higher risk of relapse,” said Dr. Richard Pazdur, director of the FDA Oncology Center for Excellence, the statement said.
AML is a rapidly progressing cancer that affects the number of normal blood cells and calls for continuous transfusions, the FDA said in a statement.
Both treatments received priority designation.
“The appointment of a priority review will focus overall attention and resources on evaluating drug bids, which, if approved, will be a significant improvement in the safety or effectiveness of treatment, diagnosis or prevention of serious conditions compared to standard applications,” the FDA said in a statement.