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FDA approves two cancer treatments after accelerated reviews

Vitrakvi, approved on Monday, is a "treatment for adults and pediatric patients in whom cancer has a specific genetic function (biomarker)."

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.

The Xospata tablets, approved on Wednesday, are designed to "treat adult patients who have recurrent or refractory acute myeloid leukemia (AML) with a FLT3 mutation," according to the FDA.

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 Priority Review, created in 1992, means that the FDA aims to review a drug or treatment for six months, versus 10 months for a standard review.

“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.

Both methods of treatment were also prescribed orphan drugs, status granted to medicines for rare diseases or conditions.

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