US approval of the first drug to treat cancer on a genetic basis



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The Food and Drug Administration (FDA) has approved the world's first gene-based anti-cancer drug for children and adults.

The new drug, called Vitrakvi, is aimed primarily at genetic mutations of cancerous tumors, regardless of the type of disease or the origin of the disease, said the agency in a statement released on Thursday.

She added that the drug is designed to treat adult patients with cancer and children with solid tumors or if surgical removal of tumors is likely to result in serious illness and does not involve alternative treatment or cases that have not responded to available treatments.

The drug is administered on two bodies: the first in tablets or capsules and the other in syrup for children.

To test the safety and effectiveness of the drug, FDA approval comes after three clinical trials involving 55 patients, children and adults with solid tumors, who had no treatment alternative.

The team monitored a total response rate of 75% for different types of solid tumors and these responses were permanent.

Tumors included in the drug included soft tissue tumors, a rare type of cancer that affects muscles, adipose tissue or fibrosis, as well as salivary gland cancer, thyroid cancer and lung cancer.

"The approval of the release and the introduction of this drug is an important step in the treatment of cancer because it treats it from its source," said the Commissioner of the Food and Drug Administration, Scott Gottlieb.

Gottlieb added that the new drug will help cancer patients receive appropriate treatment and help treat people with different tumors but with common genetic mutations.

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