A cutting-edge cancer treatment focusing on genetic biomarkers rather than any specific type of cancer has won accelerated approval from the Food and Drug Administration.
The approval of this week for Vitrakvi, the brand name for larotrectinib, marks a new method for developing cancer drugs that are "tissue agnostic" – cancer that is not specific to one organs such as 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.
Just the test for the cancer costs thousands, and the price tag for the treatment could reach hundreds of thousands of dollars. It's not clear how much of that a patient would pay, but Bayer says nobody who needs the drug will do without it.
"There has been no treatment for cancer that frequently expresses this mutation, such as mammary analogue secretory carcinoma, cellular or mixed congenital mesoblastic nephroma and infantile fibrosarcoma," the FDA said in a statement.
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The treatment specifically goes after mutations in DNA, and the numbers are encouraging. Five-fifth percent of the drug's recipients responded, and 73 percent of respondents lasted for at least six months. Almost 40 percent lasted a year or more, the FDA said.
FDA Commissioner Scott Gottlieb called the approval the latest step in "a significant shift towards treating cancer based on their tumor genetics."
The approval reflects advances in the use of genetic biomarkers to guide drug development aimed at targeting the delivery of medicine, he said. He adds that the drug's development would not have been possible a decade ago.
Vitrakvi's accelerated approval allows the FDA to approve drugs for serious conditions to fill in unmet medical need using clinical trial data that appears to predict a clinical benefit to patients. Further clinical trials are in the works, the FDA says.
The FDA has granted the drug a priority review and breakthrough therapy designation. Vitrakvi also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
"We now have the ability to make sure the right patients get the right treatment at the right time," Gottlieb said.
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