Loxo Oncology Inc. said the U.S. Food and Drug Administration granted breakthrough therapy designation to its thyroid cancer medicine LOXO-292.
The Stamford, Conn.-based biopharmaceutical company said the FDA status was granted to treat patients with certain tumor mutations whose thyroid cancer worsened following other treatments.
Loxo said the breakthrough therapy designation is the third granted to LOXO-292. The company said the FDA decision was based on data from its ongoing phase 1/2 trial, dubbed Libretto-001, during which the drug has shown efficacy.
The FDA grants breakthrough therapy designation to expedite the development and review of drugs that demonstrate substantial improvement over existing therapies to treat a serious or life-threatening disease or condition.