Loxo Oncology Inc. said the U.S. Food and Drug Administration granted breakthrough therapy designation to LOXO-292, a potential treatment for certain types of lung and thyroid cancers.
The designation is based on the results of an ongoing early stage clinical trial where the drug demonstrated tumor reduction in about 80% of the patients enrolled in the study.
Under the FDA's breakthrough therapy designation, the regulator expedites the development and review of drugs, which demonstrate substantial improvement over existing therapies to treat a serious or life-threatening disease or condition.
The Stamford, Conn.-based biopharmaceutical company intends to update its program regarding the long-term development of the therapy after regulatory feedback in 2019.
Loxo is currently focused on the development of LOXO-195 and larotrectinib with Bayer AG.