A new cancer treatment based on genetic biomarkers rather than the specific type of cancer has gained accelerated approval from…
This week’s approval for Vitrakvi, the brand for larotrectinib, marks a new method for developing cancer drugs, which is “agnostatic tissue” – cancer that is not specific to a body like colon or breast cancer.
Vitrakvi, developed by Bayer and Loxo Oncology, is designed to treat solid tumors from TRK fusion cancer wherever it develops in the body. The particular mutation is rare – and the treatment is not cheap.
Only the cancer test costs thousands and the price of treatment can reach hundreds of thousands of dollars. It is not clear how much a patient would pay, but Bayer says that no one who needs the drug will do it without it.
“There had been no treatment for cancer that often expresses this mutation, such as the pancreas analogous secretory carcinoma, cellular or mixed congenital mesoblastic nephroma and infantile fibrosarcoma,” the FDA said in a statement.
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Treatment goes specifically for mutations in DNA, and the numbers are encouraging. Seventy-five percent of drug recipients answered and 73 percent of responses lasted at least six months. Almost 40 percent lasted one year or more, FDA said.
FDA Commissioner Scott Gottlieb called approval the latest step in “an important change in the treatment of cancer due to their tumor genetic”.
The approval reflects progress in the use of genetic engineering will biomarkers aim to guide drug development aimed at targeting delivery of medicine, he said. He added that the drug’s development would not have been possible a decade ago.
Vitracial accelerating approval allows the FDA to approve drugs for severe conditions to fulfill an unsaved medical need using clinical trial data that seems to predict a clinical benefit for patients. Further clinical trials are in place, says FDA.
The FDA had assigned the drug a priority review and breakthrough therapy term. Vitrakvi also received Orphan Drug designation, which provides incentives to help and encourage the development of drugs for rare diseases.
“We now have the opportunity to ensure that the right patients receive proper treatment at the right time,” says Gottlieb. .
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