A cutting-edge cancer treatment which is focusing on genetic biomarkers eventually won accelerated approval from the FDA.
Vitrakvi is the brand name for larotrectinib. Its approval marks a brand new method for developing cancer drugs that are “tissue agnostic.”
This means cancer that is not specific to one organ such as colon or any type of cancer. Vitrakvi was developed by Bayer and Loxo Oncology and it’s designed to treat solid tumors from TRK fusion cancer wherever it develops in the body.
The mutation is a very rare one and as you can imagine, the treatment is not cheap. Just the test for the cancer is priced at thousands of dollars and the price tag for the treatment could reach even hundreds of thousands.
According to Bayer, nobody who needs this drug will do without it.
“There had been no treatment for cancers that frequently express this mutation, like mammary analog secretory carcinoma, cellular or mixed congenital mesoblastic nephroma and infantile fibrosarcoma,” the FDA said in a statement.
The treatment kills mutations in DNA
It seems that the numbers are more than encouraging.
75% of the drug’s recipients responded great to the treatment and 73% of responses lasted for at least six months. Almost 40% lasted for a year or even more, according to the FDA.
FDA Commissioner Scott Gottlieb called the approval the latest step in “an important shift toward treating cancers based on their tumor genetics.”
This approval of the treatment marks a milestone in the use of genetic biomarkers to guide drug development which is aimed at more closely targeting the delivery of medicine.
It seems that the drug’s development would not have been possible 10 years ago for instance.
“We now have the ability to make sure that the right patients get the right treatment at the right time,” Gottlieb said.
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