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Biomarkers: The FDA has approved a new remedy for cancer treatment



The Food and Drug Administration (FDA) has approved a new cancer treatment that focuses on genetic biomarkers.

Approved Vitrakvi, a trade name larotectinib. This is a new method that allows the development of specific cancer drugs; especially for organs such as colon or breast.

Vitraki was created by pharmaceutical Bayer and his partner Loxo oncology. It is intended for the treatment of solid tumors in any part of the body where certain biomarkers are present; that is, if the cancer has a specific mutation, the drug will attack him no matter where this has occurred.

According to experts, The future to overcome cancer lies in the genetic approachIn other words, it is about developing drugs from identifying the exact site where cancer is mutated.

Michael Winer, oncologist of the Department of Pediatric Medicine University of Columbia, said that between 40% and 50% of newly diagnosed cancer patients could benefit from precision medicine.

As for Vitravija, 75% of the drug recipient responded. 73% of the response lasted for at least six months; 40% reaches a year or more.

Scott Gottlieb, FDA Commissioner, said the approval was a major change to treating cancer based on his tumor genetics. This is a reflection of advances in the use of genetic biomarkers leading drug development.

Accelerated approval permits the approval of medicines for serious conditions that predict clinical benefit for patients.

The FDA assigned the Vitrace tag Priority overview and advanced therapyIn addition, it was classified as an orphan drug, which offers incentives to assist and encourage the development of rare diseases.

The disadvantage of this treatment is that it is very expensive. The monthly price of the oral version is more than $ 32,000. However, Bayer has released two approaches to patient programs:

  • The payment will be reimbursed if patients are not receiving clinical benefit within 90 days of treatment.
  • Support and support services are available to the patient.

Biomarkers are the future of medicine

One of the greatest challenges of medicine is to anticipate and assess the risk that a particular person or patient suffers from a pathological event. That is why biomarkers became important.

According to National Institutes of Health, Biomarkers are biological, biochemical, anthropometric and physiological properties. They are measurable in the same way; and allow the identification of physiological or pathological processes or pharmacological response to therapeutic intervention.

There are different types of biomarkers: diagnostic, prognostic and therapeutic. The ideal biomarker, say some researchers, is sensitive, predictable, fast and economical; Also, it is stable in vitro and in vivo; is not invasive; and has preclinical and clinical relevance that makes it possible to modify decisions regarding the pathological process to which it applies.


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