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Biomarkers: The FDA approves a new drug for the treatment of cancer



The Food and Drug Administration (FDA) approved a new treatment for cancer genetic biomarkers.

It was admission Vitrakvi, trade name larotectinib. This is a new method that allows you to do this developing specific anti-cancer medications; especially for colon or breast organs.

Vitraviri Bayer, a pharmacist and his oncology partner, founded his. It is designed to treat strong tumors anywhere in the body of certain biomarkers; That is, if there is a specific cancer mutation, medicine will not attack any where it occurs.

According to experts, It is based on a genetic approach to overcoming cancer in the future. In other words, it develops medications to identify the specific place where cancer is mutated.

Michael Winer, Oncologist at Pediatrics Department Columbia University, children diagnosed with cancer could achieve precision medicine between 40% and 50%.

As for Vitraviu, 75% of drug users responded. 73% of the responses lasted for at least six months; In one or more years they achieved 40%.

Scott Gottlieb, FDA Commissioner, has said it is a major change in cancer treatment based on tumor genetics. This is a reflection of the use of genetic biomarkers that guide the development of medication.

Rapid study allows the acceptance of serious conditions to predict a clinical benefit.

The FGA named Vitracvi Priority review and advanced therapy. In addition, it was classified as an orphan drug, which provides incentives to support and promote the development of rare diseases.

The disadvantage of this treatment is very expensive. The monthly version of the oral version is over $ 32,000. However, Bayer made known to both patients access programs:

  • The payment will be refunded if the patients do not receive treatment within 90 days.
  • Grants support services and patient support will be provided.

Biomarkers are the future of medicine

One of the greatest challenges in medicine is to predict and estimate the risk of suffering from a pathological condition to a specific patient or patient. That's why biomarkers have been important.

According to this The National Health Institute, Biomarkers are biological, biochemical, anthropometric and physiological characteristics. They are also measures; and the physiological or pathological processes or pharmacological response of therapeutic intervention.

There are several types of biomarkers: diagnosis, prognosis and therapeutics. The ideal biomarker, some researchers say, is sensitive, predictive, fast and inexpensive; It is also stable in vitro and in vivo; is not invaders; It has a clinical and preclinical relevance to change the decisions about the pathological process applied.


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