Stamford-based Loxo gains FDA approval for cancer drug

November 27, 2018 GMT

Loxo Oncology has gained the U.S. Food and Drug Administration’s approval of its first cancer drug.

Vitrakvi is a medication for adult and pediatric patients whose cancers have the “TRK fusion” genetic mutation and who have previously taken other drugs or do not have other treatment alternatives. The FDA’s endorsement means Stamford-based Loxo can now start selling the drug.

“Today’s approval marks another step in an important shift toward treating cancers based on their tumor genetics rather than their site of origin in the body,” FDA Commissioner Scott Gottlieb said in a statement Monday. “This new site-agnostic oncology therapy isn’t specific to a cancer arising in a particular body organ, such as breast or colon cancer. Its approval reflects advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine. We now have the ability to make sure that the right patients get the right treatment at the right time.”


Founded in 2013, Loxo is developing several drugs to treat cancers linked to genetic mutations. In September, it gained “Breakthrough Therapy Designation” from the FDA to accelerate the agency’s review of another drug, Loxo-292.