The Food and Drug Administration (FDA) approved a new cancer treatment that focuses on genetic biomarkers.
The approval was for Vitrakvi, The business name of larotectinib. This is a popup that allows the development of specific drugs against cancer; especially for organs like the colon or the sine.
Vitrakvi was created by the pharmacist Bayer and his partner, Loxo Oncology. It is designed to treat solid tumors in any part of the body where certain biomarkers are found; That is, if the cancer has a specific mutation, the medication will attack no matter where it came from.
According to the specialists, The future to overcome cancer is in the genetic approach. In other words, it is about developing medications from the identification of the exact site where cancer mutates.
Michael Winer, oncologist from the Department of Pediatrics of the University of ColumbiaHe stated that between 40% and 50% of children with cancer recently diagnosed could benefit from precision medicine.
As for Vitrakvi, 75% of the recipients of the medication responded. 73% of the response lasted for at least six months; 40% achieved the year or more.
Scott Gottlieb, FDA commissioner, said approval was a major change in the treatment of cancer based on its tumor genetics. This is a reflection of the advances in the use of genetic biomarkers that guide the development of medications.
Accelerated approval allows to give approval to drugs due to serious conditions and that predict a clinical benefit for patients.
The FDA granted Vitrakvi the designation of Priority review and advanced therapy. In addition it was classified as an orphan drug, which offers incentives to help and encourage development for rare diseases.
The inconvenience of this treatment is that it is very expensive. The monthly price of the oral version is more than 32 thousand dollars. However, Bayer announced two access programs for patients:
- Payment will be reimbursed if patients do not experience clinical benefit within 90 days after the treatment begins.
- Reimbursement support and patient assistance services will be provided.
Biomarkers are the future of medicine
One of the greatest challenges of medicine is in predicting and estimating the risk that a specific person or patient has to suffer from a pathological event. For this reason, biomarkers have become important.
according to him National Institutes Health, Biomarkers are the biological, biochemical, anthropometric and physiological characteristics. In the same way, they are measurable; and allow to identify physiological or pathological processes, or a pharmacological response to a therapeutic intervention.
There are different types of biomarkers: diagnoses, prognosis and therapeutics. The ideal biomarker, some researchers say, is sensitive, predictive, fast and economical; Likewise, it is stable in vitro and in vivo; it is not invasive; And it has preclinical and clinical relevance that allows to modify the decisions regarding the pathological process to which it applies.