Vitrakvi, approved Monday, is "treatment for adults and children where cancer has a specific genetic property (biomarker)". The FDA said…
The FDA said in a statement that it is the second approved cancer treatment based on a tumor biomarker instead of the place in the body where the tumor originates. Vitracvi will be used for the treatment of solid tumors that have an NTRK gene fusion that has no known resistance mutation, which is not metastatic or where surgical removal is likely to lead to severe morbidity and has no alternative treatments or has developed after treatments .
NTRK genes are rare but occur in many types of cancer, the FDA says, such as the pancreas analog secretory carcinoma and infantile fibrosarcoma.
Xospata tablets, approved Wednesday, concern “treatment of adult patients with recurrent or refractory acute myeloid leukemia (AML) with a FLT3 mutation,” according to the FDA.
In addition to the tablets, the agency also approved a diagnosis to detect the mutation.
“About 25 to 30 percent of patients with AML have a mutation in the FLT3 gene. These mutations are associated with a particularly aggressive form of disease and a higher risk of relapse,” said Richard Pazdur, director of FDA’s Oncology Center of Excellence, said in the statement.
AML is a fast-moving cancer that affects the number of normal blood cells and requires continuous transfusions, “said the FDA.
Both treatments were granted priority review.
992, means that the FDA aims to examine the drug or treatment within six months, as opposed to 10 months for a standard assessment.
“A priority review will focus overall attention and resources on the evaluation of drug applications, which, if approved, would significantly improve the safety or effectiveness of treatment, diagnosis or prevention of serious conditions compared to standard applications,” says FDA.
Both treatments also received orphan drug designation, a status granted for rare diseases or conditions.