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The FDA said in a statement that it was the second approved cancer treatment based on a tumor biomarker in place of the tumor in the body.
Vitrakvi will be used for the treatment of solid NTRK (neurotrophic receptor tyrosine kinase) gene fusion tumors lacking a known resistance mutation, which are not metastatic or whose surgical removal is likely to be significant. cause severe morbidity and that have no other treatments or have progressed after the treatments.
NTRK genes are rare but occur in many types of cancer, according to the FDA, such as bad-like secretory carcinoma and infantile fibrosarcoma.
In addition to the tablets, the agency also approved a diagnosis to detect the mutation.
"About 25 to 30% of AML patients have FLT3 mutations, which are badociated with a particularly aggressive form of the disease and a higher risk of relapse," said Dr. Richard Pazdur. director of the FDA. Center of Excellence in Oncology, said in the statement.
AML is a rapidly evolving cancer that affects the number of normal blood cells and requires ongoing transfusions, the FDA said.
Both treatments received priority badessment status.
"A priority review designation will direct overall attention and resources to the badessment of drug claims that, if approved, would be a significant improvement in the safety or efficacy of treatment, diagnosis or the prevention of serious conditions compared to the standard applications, "says the FDA.
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