FDA approves two cancer treatments after expedited reviews

Vitrakvi, approved on Monday, is "a treatment for adult and pediatric patients whose cancers have a specific genetic characteristic (biomarker)".

The FDA said in a statement that it was the second approved cancer treatment based on a tumor biomarker instead of the place in the body where the tumor originated.

Vitrakvi will be used for the treatment of solid tumors with NTRK gene fusion (neurotrophic receptor tyrosine kinase) that do not have a known resistance mutation, that are not metastatic or whose surgical ablation is likely to lead to severe morbidity. no alternative treatments or have progressed after the treatments.

NTRK genes are rare but exist in many types of cancer, the FDA said, such as secretory breast carcinoma and infant fibrosarcoma.

The Xospata tablets, approved Wednesday, are intended for the "treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation," according to the FDA.

In addition to the tablets, the agency has also approved a diagnosis to detect the mutation.

"About 25 to 30% of AML patients have FLT3 mutations, which are associated with a particularly aggressive form of the disease and a higher risk of relapse," said Dr. Richard Pazdur, Center Director. oncology of the FDA. Excellence, said in the statement.

AML is a rapidly progressive cancer that affects the number of normal blood cells and requires ongoing transfusions, the FDA said.

Both treatments received priority assessment status.

The Priority Review, established in 1992, means that the FDA's goal is to revise the drug or treatment within six months, instead of 10 months for a standard revision.

"A priority assessment designation will direct overall attention and resources on the assessment of drug claims that, if approved, would constitute significant improvements in safety or effectiveness." treatment, diagnosis or prevention of serious problems compared to standard applications "says the FDA.

Both treatments also received the orphan drug designation, status assigned to drugs for rare diseases.

Source link