Loxo Oncology: FDA Grants Orphan Drug Designation To Larotrectinib

(RTTNews) - Loxo Oncology Inc. (LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, announced Friday that the U.S. Food and Drug Administration has granted orphan drug designation to larotrectinib for the "treatment of solid tumors with NTRK-fusion proteins."

NTRK fusions are genetic abnormalities that occur rarely in various adult and pediatric solid tumors.

The FDA's Office of Orphan Drug Products grants orphan drug designation to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the United States.

Orphan drug designation provides to Loxo Oncology certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.