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The Food and Drug Administration says it has approved the drug Vitrakvi for adult and pediatric patients whose cancers have a specific biomarker.
"Today's approval marks a new milestone in a significant shift to cancer treatment based on the genetics of their tumor rather than their original site in the body," said the FDA commissioner. Scott Gottlieb, MD "We are now able to ensure that good patients receive the right treatment at the right time."
Vitrakvi, the brand name of larotrectinib, has received the FDA seal for the treatment of adult and pediatric patients with solid tumors containing gene fusion of the neurotrophic receptor tyrosine kinase.
The researchers claim that the NTRK genes can be fused abnormally to other genes, which can lead to tumor growth. Although NTRK fusions are rare, they occur during cancers in many body sites, according to the FDA. Before Monday's announcement, there was no treatment for cancers containing the mutation.
According to the FDA, larotrectinib demonstrated an overall response rate of 75% to the tumors tested. These responses were sustainable: 73% of them lasted at least six months and 39% lasted a year or more at the time of the badysis of the results. Soft tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, thyroid cancer, and lung cancer tumors were among the groups tested that responded to treatment.
Doctors warn however that the drug does not work for all cancers – and that it is expensive. The wholesale price of children's syrup is $ 11,000 for a month's supply and that of adult oral capsules for adults is $ 32,000 a month. With insurance, most patients would pay $ 20 or less for a 30-day supply.
The success of these trials led to accelerated approval by the FDA, which allowed Vitrakvi to be used for patients with serious illnesses not currently treated in medicine.
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