State-of-the-art cancer treatment, focused on genetic biomarkers rather than a specific type of cancer, was quickly approved by the Food and Drug Administration.
The approval of Vitrakvi, the brand name of larotrectinib, this week marks a new method of developing "tissue agnostic" anti-cancer drugs, a non-organ-specific cancer such as colon cancer or cancer. breast.
Vitrakvi, developed by Bayer and Loxo Oncology, is designed to treat solid tumors of TRK fusion cancer, wherever they grow in the body. The particular mutation is rare – and the treatment is not cheap.
The only test for cancer costs thousands of dollars and the price of treatment could reach hundreds of thousands of dollars. It's unclear how much this patient would pay, but Bayer says anyone who needs this medication will not be able to do without it.
"There had been no treatment for cancers that frequently express this mutation, such as breast secretory carcinoma, mixed mesoblastic or mixed mesoblastic nephroma and infantile fibrosarcoma," the FDA said in a statement.
The treatment specifically targets the mutations of the DNA.
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The numbers are encouraging. Seventy-five percent of the recipients of the drug responded and 73% of the responses lasted at least six months. Nearly 40% lasted a year or more, the FDA said.
FDA Commissioner Scott Gottlieb said the approval was the last step in a "significant change in cancer treatment based on the genetics of their tumors."
The approval reflects the progress made in using genetic biomarkers to guide the development of drugs aimed at targeting drug delivery more closely, he said. He added that the development of the drug would not have been possible ten years ago.
Vitrakvi's accelerated approval allows the FDA to approve drugs to treat critical illnesses to address an unmet medical need, using clinical trial data that seems to predict a clinical benefit to patients. The FDA has announced that other clinical trials are underway.
The FDA had granted the drug a priority assessment designation and revolutionary therapy. Vitrakvi has also been awarded the Orphan Drug Title, which provides incentives to help and encourage the development of drugs for rare diseases.
"We are now able to ensure that the right patients receive the right treatment at the right time," Gottlieb said.
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