Loxo Oncology Inc. completed the rolling submission of its new drug application to the U.S. Food and Drug Administration for its cancer medicine larotrectinib.
The company seeks approval for the drug to treat solid tumors with the neurotrophic tyrosine receptor kinase, or NTRK, gene fusion that locally progressed or already spread. NTRK gene fusions are genetic alterations that can cause tumor growth.
Loxo Oncology initiated the rolling submission in December 2017. A marketing authorization application is expected to be filed with the EU in 2018.
The Stamford, Conn.-based company is co-developing the drug with Bayer AG.