Friday , March 5 2021

FDA approves two cancer treatments after expeditious examination

Vitracer, approved on Monday, is "treating adult and pediatric patients whose cancer has a specific genetic trait (biomarker)".

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.

The Xospata tablets, approved on Wednesday, are for "treating adult patients who have relapses or acute myeloid leukemia (AML) with FLT3 mutations," according to the FDA.

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 Preliminary Review, established in 1992, means that the FDA aims to review the drug or treatment within six months, versus 10 months for a standard examination.

"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.

Both treatments also received an orphan treatment, a status approved for medicines for rare diseases or conditions.

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